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p-Tert-Butylphenol - UNEP Chemicals

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OECD SIDS P-TERT-BUTYLPHENOL<br />

110<br />

by an occlusive patch and fixed with a bandage for 48 hours. For the<br />

challenge treatment after 2 weeks, surgical gauze was covered with 0.2g of<br />

the 1 % test substance in Vaseline and placed onto the clipped right flank of<br />

the animals. An occlusive patch with the vehicle alone was applied to the left<br />

flank. The patches were held in contact with the skin by an occlusive patch<br />

and fixed with a bandage for 24 hours. Assessment took place 48 and 72<br />

hours after administration.<br />

Reference: Hüls Infracor GmbH: 1998<br />

(b)<br />

Type:<br />

Species/strain: Guinea pig<br />

Results: Sensitizing [X]; Not sensitizing [ ]; Ambiguous [ ]<br />

Classification: Sensitizing [ ]; Not sensitizing [ ]<br />

Method: Other<br />

GLP: Yes [ ] No [ ] ? [X]<br />

Test substance: purity: unknown<br />

Remarks: 20 white female guinea pigs were painted daily on the bare skin behind their<br />

ears with one drop of 30 % solution of a p-t-butylphenol resin in ethyl acetate<br />

for three weeks followed by a two weeks rest. 0.5 % resin and 1 % p-tbutylphenol<br />

in ethyl acetate was applied behind the right and left nipple,<br />

respectively and biopsies were conducted after 48 hours. In histological<br />

examination, 15 of 20 guinea pigs showed contact allergic reactions to the<br />

resin. 7 of these 15 animals showed positive reactions to p-t-butylphenol and<br />

in 8 of these 15 animals sensitization appears not to be based upon a<br />

demonstrable sensitivity to p-t-butylphenol. Starting with an application of<br />

30 % p-t-butylphenol behind both ears followed by application of 1 % p-tbutylphenol<br />

and 0.5 % resin behind the right and left ear, respectively, 14<br />

animals were sensitized with p-t-butylphenol and 9 of these also reacted to<br />

the resin (procedure as described above).<br />

Reference: Malten: 1967<br />

*5.4 REPEATED DOSE TOXICITY<br />

(a)<br />

Species/strain: Rats/Crj:CD (SD)<br />

Sex: Female [ ]; Male [ ]; Male/Female [ X ]; No data [ ]<br />

Route of Administration: Oral (gavage)<br />

Exposure period: 14 days<br />

Frequency of treatment: Daily<br />

Post exposure observation period: 1 day<br />

Dose: 0 (Vehicle), 250, 500, 1,000 mg/kg/day<br />

Control group: Yes [X]; No [ ]; No data [ ]; 0.5% aqueous methyl cellulose<br />

Concurrent no treatment [ ]; Concurrent vehicle [X]; Historical [ ]<br />

NOEL:<br />

LOEL: 250 mg/kg/day<br />

Results: At 1,000 mg/kg, the body weights were 10% lower than control at day 9, and<br />

3/5 females and 1/5 male died up to day 9. At this time, all other survivors<br />

were dissected but no toxic sign was observed by necropsy. Two females<br />

continuously showed difficulty of breathing with noisy respiratory sound.<br />

At 500 mg/kg, abnormality was only noisy respiratory sound in 3/5 animals<br />

of both sexes. At 250 mg/kg, 1/5 female showed noisy respiratory sound.<br />

Method: Other (Dose finding study)<br />

GLP: Yes [ ] No [X] ? [ ]<br />

<strong>UNEP</strong> Publications

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