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OECD SIDS m- / p-CRESOL MIXTURE 5. TOXICITY ID: 15831-10-4 DATE: 24.05.2004 and liver. Microscopic changes which were characterized by average severity score based on scale of 1 to 4 (1=minimal, 2=mild, 3=moderate, 4=marked) were reported from nose (contr., low dose to high dose, respiratory epithelium hyperplasia: male, 0/5, 300 and 1000 ppm: not performed, 0/5, 1/5[1.0], 5/5[1.6]; female, 2/5[1.5], low dose: not performed, 0/5, 3/5[1.0], 3/5[1.7], 4/5[1.5]; olfactorium epithelium: at 30000 ppm, male, atrophy 2/5[1.0] and respiratory metaplasia 3/5 [1.3]; female, olfactory epithelium respiratory metaplasia at 30000 ppm, 2/5[1.0]), lung (bronchiolar hyperplasia, minimal in males and females at 30000 ppm), oesophagus (males, minimum hyperplasia and hyperkeratosis at 30000 ppm), forestomach (males, at 30000 ppm, minimal hyperplasia of the squamous epithelium), bone marrow (minimal hypocellularity at 30000 ppm), atrophy of the ovary (mild) and uterus (moderate) at 30000 ppm local toxicity: NOAEL(male): 3000 ppm; NOAEL(female): 1000 ppm systemic toxicity: NOAEL(male): 300 ppm; NOAEL(female): 1000 ppm Reliability : (1) valid without restriction Flag : Critical study for SIDS endpoint 05.02.2004 (101) Type : Sub-acute Species : mouse Sex : male/female Strain : CD-1 Route of admin. : oral feed Exposure period : 14 d Frequency of treatm. : daily Post exposure period : no Doses : 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0 % (target dose: 0, 375, 750, 1500, 2250, 3000, 4500 mg/kg bw) Control group : yes, concurrent no treatment Method : other: NTP continuous breeding protocol, task 1 see freetext ME Year : 1990 GLP : yes Test substance : other TS: m-/p-cresol (60%/40%) Method : 48 male and 48 female mice: 8 per sex per dose, data collected included clinical signs, individual body weights, feed and water consumption, mortality data Result : mortality: 3.0 %-gr.: 1/8 (12.5 %) males, 1/8 (12.5 %) females (due to indeterminant causes) Clinical signs: all mice in 3.0 %-, and some in 2.0 %- and 1.0 %-group: lethargy, hunched back, squinted eyes, rough coat dose related reduced feed consumption, water consumption and reduced body weight gain 3 %-group: sign. terminal weight loss of males and females Reliability : (2) valid with restrictions preliminary dose range finding study for the two generation reproductive study: see also chapter 5.8.1 04.09.2002 (102) 362 UNEP PUBLICATIONS
OECD SIDS m- / p-CRESOL MIXTURE 5. TOXICITY ID: 15831-10-4 DATE: 24.05.2004 5.5 GENETIC TOXICITY ‘IN VITRO‘ Type : Ames test System of testing : Salmonella typhimurium TA 97, TA98, TA100, TA 1535 Test concentration : 0, 10, 33, 100 333, 1000, 3333 , 6666 ug/plate dissolved in DMSO Cycotoxic concentr. : High dose was limited by toxicity or solubility Metabolic activation : with and without Result : negative Method : other: EPA OTS 798.5265, see also fretext ME Year : 1990 GLP : yes Test substance : other TS: m/p-cresol (60/40), Method : detailed protocol in Zeiger 1988 Environ. Molec. Mutagen. 11 (Suppl.12), 1- 158: The metabolic activation system was prepared from Aroclor 1254- induced male Sprague-Dawley rat and male Syrian hamster livers, and used as 10% or 30% concentrations SOLVENT: DMSO CONTROL. DMSO and 2-aminoanthracene, 4-nitro-o-phenylenediamine, sodium azide, 9-aminoacridine served as negative and positive controls, respectively. Remark : The positive control was functional. Reliability : (2) valid with restrictions only 4 strains were used Flag : Critical study for SIDS endpoint 05.02.2004 (101) 5.6 GENETIC TOXICITY ‘IN VIVO‘ Type : Micronucleus assay Species : mouse Sex : male/female Strain : B6C3F1 Route of admin. : oral feed Exposure period : 13 weeks Doses : 0, 625, 1250, 2500, 5000, 10000 ppm (approx. m: 0,96, 194, 402, 776, 1513mg/kg bw; f: 116, 239, 472, 923, 1693 mg/kg bw) Result : negative Method : other: see ME Year : 1990 GLP : yes Test substance : other TS: m/p-<strong>Cresol</strong>: 60:40 Method : 10 mice/sex/dose treated for 13 weeks (see also Chapter 5.4) at termination smears were prepared from blood sampled by cardiac puncture from control and dosed mice: 10000 normochromatic erythrocytes from each mice scored for micronuclei Remark : for signs of toxicity see chapter 5.4 Result : No significant elevation in the frequency of micronucleated erythrocytes was observed in either male or female mice Reliability : (2) valid with restrictions not fully in accordance with the guideline, e.g. no positive control Flag : Critical study for SIDS endpoint 16.12.2002 (101) UNEP PUBLICATIONS 363
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OECD SIDS m- / p-CRESOL FOREOWRD IN
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OECD SIDS m- / p-CRESOL 11. Comment
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OECD SIDS m- / p-CRESOL of mice. In
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OECD SIDS m- / p-CRESOL SIDS Initia
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OECD SIDS m- / p-CRESOL Table 3: Es
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OECD SIDS m- / p-CRESOL m-cresol an
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OECD SIDS m- / p-CRESOL extensive s
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OECD SIDS m- / p-CRESOL et al. 1993
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OECD SIDS m- / p-CRESOL study in wh
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OECD SIDS m- / p-CRESOL Conclusion:
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OECD SIDS m- / p-CRESOL Table 5: m-
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OECD SIDS m- / p-CRESOL ≥300 ppm,
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OECD SIDS m- / p-CRESOL Atrophy and
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OECD SIDS m- / p-CRESOL p-Cresol p-
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OECD SIDS m- / p-CRESOL 3.1.7 Carci
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OECD SIDS m- / p-CRESOL 5 RECOMMEND
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OECD SIDS m- / p-CRESOL BRRC (Bushy
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OECD SIDS m- / p-CRESOL Hamster Ova
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OECD SIDS m- / p-CRESOL Nobel W, Ma
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OECD SIDS m- / p-CRESOL Vernot EH,
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OECD SIDS m- / p-CRESOL √ informa
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