Registration Dossier
Registration Dossier
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EC number: 238-677-1 | CAS number: 14634-93-6
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study the test substance was given as a 40% (w/v) suspension in propylene glycol to a group of ten male and ten female rats in one single dose of 25 ml/kg body weight. The rats were observed for signs of intoxication during a 14-day period. At the end of the observation period autopsies were carried out on the survivors. Four male and 1 female rats died. The LD50 is > 10000 mg/kg bw.
No acute inhalation or dermal toxicity studies are available.
According to Commission Regulation (EU) 2016/863 of May 2016, (point 8.5 of Annex VIII) for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Based on the physicochemical data (vapour pressure of the substance is of 1.0E-4 Pa at 50°C (measured), water solubility of 0.07 mg/l at 20 °C and the log Kow of 3.4 at 20 °C testing by dermal route seems appropriate.
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Study well documented, meets generally accepted scientific principles, acceptable for assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In an acute oral toxicity study theLD50 for male and female rats was >10000 mg/kg body weight.
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified for acute oral and dermal toxicity.
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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