Registration Dossier

Administrative data

Description of key information

Oral LD50 (OECD guideline 401), rat = 2730 mg/kg bw
Dermal LD50 (OECD guideline 402), rat > 2000 mg/kg bw (limit test)
Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 730 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Additional information

The acute toxicity of alcohol ethoxysulfates has been extensively evaluated in numerous oral and dermal toxicity studies. Therefore this endpoint is covered by read across from structurally related AES. The AES reported within the AES category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read across approach between structurally related AES. For details please refer to the category justification attached in IUCLID section 13.

The oral LD50 values based on the test material were all at least above 2 g/kg and the same result was achieved for the dermal route when tested.

Acute toxicity by inhalation was not tested as according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2.

In summary, no classification is warranted for either route of acute toxicity.

The following information is taken into account for any hazard / risk assessment:

Many high quality studies investigating the acute toxicity of alcohol ethoxysulfates (AESs) have shown that in terms of acute toxicity the use of these compounds are of low concern. They are of low oral and dermal toxicity.

References:

Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28

HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject. com.


Justification for selection of acute toxicity – oral endpoint
The reliable OECD Guideline study which resulted in the LD50 was chosen.

Justification for selection of acute toxicity – dermal endpoint
Reliable OECD guideline study.

Justification for classification or non-classification

Classification criteria according to 67/548/EEC and (EC) 1272/2008 are not fulfilled.