Registration Dossier
Registration Dossier
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EC number: 905-908-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a 90-day oral repeated dose toxicity study with rats, conducted according to OECD/EC guidelines and GLP principles, abnormalities in estrous cycle (coinciding with microscopic alterations in ovaries and/or uterus and/or vagina) were observed in females dosed at 300 mg/kg bw/day. In males, increased incidence and severity of hypertrophy/hyperplasia of the follicular cells of the thyroid glands were found at 1000 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
- 100 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The study was performed according to OECD/EC guidelines and GLP principles (Klimisch 1 study).
- System:
- female reproductive system
- Organ:
- ovary
- uterus
- vagina
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
The observed adverse effects in a subchronic oral toxicity study, namely irregular estrous cycle and the reduction in corpora lutea, accompanied by the delay in fetal development, mandate a classification of CXN1-55 as reproductive toxicant category 2 according to Regulation (EC) No. 1272/2008. The substance is not further classified for repeated dose toxicity.
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