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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (OECD guideline 423), rat > 2500 mg/kg bw (limit test)
Dermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute oral toxicity

An acute oral toxicity study performed according to OECD TG 423 and in compliance with GLP with Amides, C18, branched and linear is available (Sanders, 2003). In this limit test six fasted female Sprague-Dawley rats were administered one dose of 2000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. The acute oral LD50 was calculated to be greater than 2500 mg/kg bw according to the protocol of OECD TG 423. No signs of clinical toxicity were reported, no mortalities occurred during the observation period. Based on the study results and according to EU classification criteria, the test substance is not to be classified.

 

Acute dermal toxicity

An acute dermal toxicity study performed according to OECD TG 402 and in compliance with GLP with Amides, C18, branched and linear is available (Bradshaw, 2014). In this limit test five Wistar rats of each sex were exposed to 2000 mg/kg bw test substance for 24 h via semi-occlusive dressing (10% of the total body surface area) and observed for 14 days post application. No signs of clinical toxicity were reported and no mortalities occurred during the study period. The acute dermal LD50 was calculated to be greater than 2000 mg/kg bw. Based on the study results and according to EU classification criteria, the test substance is not to be classified.

 


Justification for selection of acute toxicity – oral endpoint
The reliable GLP compliant OECD Guideline study was chosen.

Justification for selection of acute toxicity – dermal endpoint
The reliable GLP compliant OECD Guideline study was chosen.

Justification for classification or non-classification

The available data on the acute toxicity of Amides, C18, branched and linear do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC and are thus conclusive but not sufficient for classification.