Registration Dossier
Registration Dossier
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EC number: 700-102-1 | CAS number: 105112-76-3
Endpoint summary
Administrative data
Description of key information
A study was performed to test the effects of repeated doses of the test substance 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline to CD rats for 28 days
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 40 mg/kg bw/day
Additional information
Information about the repeated dose toxicity of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline is available from a valid 28-day oral dose test in CD rats that were exposed to 40, 200 or 1000 mg/kg body weight/day by gavage. A dosage of 1000 mg/kg bw/day was associated with a slight macrocytic anaemia and a dosage of 200 mg/kg bw/day or more was associated with an increase in lymphocyte and neutrophil numbers. These changes were fully recovered in a group of animals that received the high dose for 30 days and were observed for another 16 days without further exposure. The NOEL in the study was 40 mg/kg bw/day.
Justification for classification or non-classification
It is concluded that oral administration of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline to CD rats for 30 days at dosage of 1000 mg/kg/day was associated with a slight macrocytic anaemia and at 200 mg/kg/day or more with an increase in lymphocyte and neutrophil numbers. These changes were fully reversible. A classification does not apply for chronic oral toxicity of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline. This is also supported by section 3.9.2.8 in the GHS and CLP documents, where it is stated that small changes in blood chemistry would not justify classification.
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