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EC number: 203-631-1 | CAS number: 108-94-1
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Neurotoxicity
Administrative data
Description of key information
American Biogenic Corporation (1986) reported a 2-generation study with rats in doses ranging from 250 - 1000 ppm. The NOAEL for parental animals was 1000 ppm, for F1 animals was 500 ppm and for the F2 animals 500 ppm.
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on neurotoxicity: via inhalation route
Link to relevant study records
- Endpoint:
- neurotoxicity: inhalation
- Remarks:
- 2-generation study
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- This reproduction study was conducted to ascertain the potential effects of inhalation exposure to the test material vapour upon reproductive performance, growth, and development of 2 consecutive generations of rats including neurotoxicity.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- see chapter Toxicity to reproduction
- Route of administration:
- inhalation: vapour
- Details on exposure:
- see chapter Toxicity to reproduction
- Duration of treatment / exposure:
- 2 generations
- Frequency of treatment:
- 6 h/d
- Dose / conc.:
- 250 ppm (nominal)
- Remarks:
- approximately 1.02 mg/L
- Dose / conc.:
- 500 ppm (nominal)
- Remarks:
- approximately 2.04 mg/L
- Dose / conc.:
- 1 000 ppm (nominal)
- Remarks:
- (resp. 1400 ppm) approximately 4.1 mg/L
- No. of animals per sex per dose:
- see chapter Toxicity to reproduction
- Control animals:
- yes, concurrent no treatment
- Observations and clinical examinations performed and frequency:
- see chapter Toxicity to reproduction
- Specific biochemical examinations:
- see chapter Toxicity to reproduction
- Neurobehavioural examinations performed and frequency:
- Assessments for potential neurotoxicologic/neuropathologic effects were conducted pre-weaning and post-weaning in each F1a litter.
- Sacrifice and (histo)pathology:
- see chapter Toxicity to reproduction
- Other examinations:
- Neurotoxicity: brain (forebrain, center of cerebrum, midbrain, cerebellum and pons, medulla oblongata and Gasserian ganglia.
- Statistics:
- see chapter Toxicity to reproduction
- Description (incidence and severity):
- Further observations for developmental neurotoxicity study
Details on results (for developmental neurotoxicity):Evaluation of the specified tissues of the nervous system of untreated control and and 1000 ppm F1a progeny selected for neurotoxicologic testing did not reveal lesions in any of the tissues. Microscopic examinations of the eyes from the F1a progeny revealed lenticular vacuolation (vacuolation of a few outer cortical fibers in the lens) for 2/115 of the 500 ppm progeny and 3/114 of the 1000 ppm progeny.
For details see chapter Toxicity to Reproduction. - Conclusions:
- The examining pathologist concluded that based on the low indicence and minimal nature of these changes, they were not treatment-related.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 4 100 mg/m³
- Study duration:
- subacute
- Species:
- rat
Effect on neurotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Evaluation of the specified tissues of the nervous system of untreated control and 1000 ppm F1a progeny selected for neurotoxicity testing did not reveal lesions in any of the tissues. Microscopic examinations of the eyes from the F1a progeny revealed lenticular vacuolation (vacuolation of a few outer cortical fibers in the lens) for 2/115 of the 500 ppm progeny and 3/114 of the 1000 ppm progeny (ABC, 1986).
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