Fatty acids, C18-unsatd., dimers, ethoxylated

Endpoint summary

Description of key information

Oral: 
- acute toxicity, oral, rat, Wistar, OECD 423, discriminating dose-value (female/male)  2000 mg/kg bw (no treatment related effects) (BASFSE, 2012, 10A0072/12X137) 
Dermal:
- acute toxicity, dermal, rat, Wistar, OECD 402, dermal discriminating dose-value (female/male) 5000mg/kg bw (no treatment related effects)  (BASFSE, 2012, 11A0072/12X138)
Inhalation:
- No information on acute inhalation available for Fatty acids, C18-unsatd., dimers, ethoxylated

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study.

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

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study.

Additional information

There are valid study data available assessing the acute oral and dermal toxicity of Fatty acids, C18-unsatd., dimers, ethoxylated. No valid information for Fatty acids, C18-unsatd., dimers, ethoxylated on inhalation toxicity is available.

Oral:

OECD conform studies:

In an acute oral toxicity study according to OECD TG 423, the test substance was administered by oral gavage to two groups of three female Wistar rats 2000 mg/kg bw(BASFSE, 2012, 10A0072/12X137). The test substance was administered undiluted at 2 mL/kg bw. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 14 days. All gross and visible toxic or pharmacological effects were recorded. No animals died on account of the treatment nor did they show severe signs of toxicity. The oral discriminating dose value of the test substance in female Wistar rats was estimated to be 2000 mg/kg bw.

 

Dermal:

OECD conform studies:

In an acute dermal toxicity study according to OECD TG 402, the test substance was administered (single 24-hour dermal application) to five Wistar rats of each sex at 5000 mg/kg bw(BASFSE, 2012, 11A0072/12X138). All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 14 days. None of these animals died. Clinical signs or dermal symptoms were not observed during the 14 days post-treatment observation period. No effects on mean body weight and body weight gain were noted. Specific macroscopic alterations related to the toxic effect of the test substance were not found. The dermal discriminating dose value of the test substance in Wistar rats was estimated to be 5000 mg/kg bw.

 

Assessment of acute toxicity:

Oral: The only available animal study points to high acute oral toxicity. The discriminating dose determined is 2000 mg/kg without any substance related effect. Therefore a very low acute oral toxicity is assumed and no classification is derived.

Dermal: The information available for the available acute dermal toxicity study points to very low dermal toxicity. The discriminating dose (without any substance related effect) determined is 5000 mg/kg. Therefore a very low acute dermal toxicity is assumed and no classification is derived.

Inhalation: No acute inhalation study available is available. This study was not proposed or conducted because exposure consideration point to a more likely dermal and oral exposure and according to the REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5 only information on two application routes needs to be provided, with test item administration via the most appropriate route.

Key study assignment:

As there is only one relevant and reliable study available assessing each the oral and the dermal toxicity and both were well performed and documented according to OECD guidelines and under GLP, these study were therefore included as key studies.

No acute inhalation study available

Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant study.

Justification for selection of acute toxicity – dermal endpoint
GLP and guideline compliant study.

Justification for classification or non-classification

Based on the available results above,no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.

Labelling for acute toxicity:

GHS: no classification

DSD: no classification