Registration Dossier
Registration Dossier
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EC number: 243-296-9 | CAS number: 19780-11-1
Endpoint summary
Administrative data
Description of key information
n-Dodecenyl succinic anhydride has been tested for acute toxicity in rats via oral, inhalation and dermal administration. No acute toxicity effects were observed which would lead to classification and labelling.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- adequate
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- adequate
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- adequate
Additional information
n-Dodecenyl succinic anhydride (n-DDSA) has been tested for acute toxicity in rats via oral, inhalation and dermal administration. In a current guideline study (OECD 425) according to GLP, the LD50 of the material given by oral gavage was > 2000 mg/kg bw. In information obtained from a secondary source (U.S. Environmental Protection Agency), a 4-hour exposure to 5300 mg/m3, or 5.3 mg/L as n-DDSA aerosol (2.3 micron mean geometric diameter in ethanol), resulted in less than 50% mortality. In a guideline study (OECD 402) according to GLP, the LD50 of the material applied dermally under occlusive wrap for 24 hours was > 2000 mg/kg bw. These data indicate that nDDSA has a low potential for acute toxicity.
Justification for selection of acute toxicity – oral endpoint
Guideline study under GLP
Justification for selection of acute toxicity – inhalation endpoint
Data is from a secondary source, but has been evaluated by a reputable authoritative body, the U.S. Environmental Protection Agency.
Justification for selection of acute toxicity – dermal endpoint
Guideline study under GLP.
Justification for classification or non-classification
The substance does not meet the criteria for classification according to Regulation EC No. 1272/2008. The oral LD50 is > 2000 mg/kg bw (the criteria for classification being ≤ 2000 mg/kg bw). The acute inhalation toxicity is > 5.3 mg/L (the criteria for classification being ≤ 5.0 mg/L as a mist). The acute dermal toxicity is > 2000 mg/kg bw (the criteria for classification being ≤ 2000 mg/kg bw).
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