Registration Dossier
Registration Dossier
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EC number: 412-570-1 | CAS number: 119462-56-5
Endpoint summary
Administrative data
Description of key information
A 28-day oral toxicity study resulted in a NOAEL of 50 mg/kg bw and a NOEL of 10 mg/kg bw. A 28-day dermal toxicity test was cancelled because of rapid and severe skin reactions during the 5-day dose range-finding test.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
In a 28 -day oral test, the NOAEL was 50 mg/kg bw. A 5 -day RF dermal toxicity showed severe skin damage at levels of 1000, 300, 100 and 30 mg/kg bw/day. The dose not causing dermal reactions would be < 1/10 of the NOAEL found in the 28-day oral study (NOAEL oral = 50 mg/kg bw); hence a dermal study was deemed not to provide useful information with regard to systemic toxicity. Because Perkalink 900 is a strong skin sensitiser it may be assumed that during the 5 -day RF test, the animals develop a primary sensitisation and, upon continued exposure, subsequently a severe allergic reaction leading to the observed skin damage.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach
Justification for classification or non-classification
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.
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