Registration Dossier
Registration Dossier
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EC number: 298-995-1 | CAS number: 93841-25-9
Endpoint summary
Administrative data
Description of key information
In a 90 day repeated dose study performed according to OECD 408, hydroxyethyl-p-phenylenediamine sulfate induced an increase in the aspartate aminotransferase and alanine aminotransferase activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day. The NOAEL in the study was 35 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 35 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Organ:
- liver
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Hydroxyethyl-p-phenylenediamine sulfate when administered orally at 25, 35, 55 mg/kg bw/day revealed a NOAEL of 35 mg/kg bw/day based on an increase in the aspartate aminotransferase and alanine aminotransferase activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day. Due to the level of NOAEL and the nature of the effect, the substance was classified according to CLP criteria as STOT RE 2 (H373 : may cause damage to organs through prolonged or repeated exposure).
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