Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study has a reliability 1.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Rats were dosed with 0, 50, 250 or 1000 mg/kg bw/d B508 via gavage in a study screening reproduction/developmental toxicity performed according to OECD 421 and GLP principles.
No mortality occurred and no clinical signs were observed. No effect on body weight, food consumption or organ weight was noted. No difference in spermatogenic staging profile was seen between treated and control groups. At macroscopy a yellowish or greenish soft nodule was noted in the epididymides (tail), which correlated with an increased incidence and severity of sperm granulomas observed at 1000 mg/kg bw/d leading to a parental NOAEL of 250 mg/kg bw/d.
Breeding parameters were unaffected by treatment up to 1000 mg/kg bw/day. There were no findings in the reproductive organs of any male or female animals suspected of infertility that would account for poor reproductive performance. Therefore, the NOAEL for reproduction toxicity was established to be at least 1000 mg/kg bw/d.
There was no treatment-related change in postnatal loss, viability index, clinical symptoms of pups, sex ratio, pup weight or external appearance at necropsy. Therefore, the NOAEL for developmental toxicity was established to be at least 1000 mg/kg bw/d.
Short description of key information:
A study in the rat performed according to OECD 421 and GLP principles was available.
Justification for selection of Effect on fertility via oral route:
One key study is available.
Effects on developmental toxicity
Description of key information
see under fertility
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study has a reliability 1.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
see under fertility
Justification for selection of Effect on developmental toxicity: via oral route:
One key study is available.
Justification for classification or non-classification
Based on the available data the substance does not need to be classified for fertility or developmental toxicity according to EC regulation 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
