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Appendix D - Dossier (PDF) - Tera

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date: 20–JUL–2005<br />

5. Toxicity Substance ID: 71–43–2<br />

______________________________________________________________________________<br />

Species: guinea pig Sex: male<br />

Strain: no data<br />

Route of administration: inhalation<br />

Exposure period: up to 269 days<br />

Frequency of treatment: 7 hours per day/5 days per week<br />

Post exposure period: 18–22 hours<br />

Doses: 0.28 mg/l; 5 or 10 guinea pigs tested<br />

Control Group: yes, concurrent no treatment<br />

NOAEL: < .28 mg/l<br />

LOAEL: = .28 mg/l<br />

Method: other<br />

GLP: no data<br />

Test substance: other TS<br />

Remark: All animals were weighed at regular intervals during the<br />

study and frequent observations made of their general<br />

appearance and behaviour. Records were kept of food<br />

consumption and mortality. The gross appearance of the<br />

lungs, heart, liver, kidneys, spleen and testes was observed<br />

and these organs weighed. Histopathological examination of<br />

these organs and the adrenals, pancreas and femoral bone<br />

marrow was made. Blood was collected from selected animals<br />

of each group at autopsy.<br />

Result: A group of five or ten animals used. Increased kidney,<br />

spleen and testes weights, growth depression and unspecified<br />

histopathological changes in the bone marrow and blood<br />

(including leucopenia) were noted.<br />

Source: BP Chemicals Ltd LONDON<br />

Test substance: 99.98% pure.<br />

13–DEC–1996 (1264)<br />

Species: guinea pig Sex: male<br />

Strain: no data<br />

Route of administration: inhalation<br />

Exposure period: 32 or 269 days<br />

Frequency of treatment: 7 hours per day, 5 days per week<br />

Post exposure period: 18–22 hours<br />

Doses: 0.28 mg/l; 5 to 10 guinea pigs tested<br />

Control Group: yes, concurrent vehicle<br />

Method: other<br />

GLP: no data<br />

Test substance: other TS<br />

Remark: Reliability: 3 (not valid)<br />

Significant methodological deficiencies<br />

one dose, low number of animals, one sex, no clinical<br />

biochemistry, limited hematology, limited pathology, no<br />

further data about results of enforced investigations, no<br />

statistical evaluation<br />

TS concentration analysed (no further data) and adjusted,<br />

variation was 10% of desired concentration.<br />

All animals were weighed at regular intervals during the<br />

study and frequent observations made of their general<br />

appearance and behaviour. Records were kept of food<br />

consumption and mortality. The gross appearance of the<br />

<strong>Appendix</strong> D: Benzene SIDS <strong>Dossier</strong><br />

– 390/957 –

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