(Z)-9-Octadecen-1-ol ethoxylated

Endpoint summary

Description of key information

Oral: LD50 > 2000 mg/kg bw

Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach.

Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances.

Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

Please refer to the category justification provided in the category object.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: Read-across based on all available data on acute oral toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category.

For a detailed assessment of the acute oral toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Applying read-across based on grouping of substances (category approach), an oral LD50 (rat, m/f) > 2000 mg/kg bw is predicted for the target substance.

Executive summary:

The available data on acute oral toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category reveal an oral LD50 value > 2000 mg/kg bw indicating only low hazardous properties of the linear AE substances after acute exposure. Based on the category approach, an oral LD50 value > 2000 mg/kg bw is considered for the target substance. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the 'linear' subgroup of the AE category are unlikely to lead to differences in the toxicological properties with respect to acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various substances in the Alcohol Ethoxylates (AE) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AE category is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH 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 study available

Additional information

Acute toxicity: oral

No data on acute oral toxicity are available for (Z)-9-octadecen-1-ol ethoxylated (CAS No. 9004-98-2, EC No. 500-016-2). In order to assess acute oral toxicity, studies in the database of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. Studies investigating acute oral toxicity are available for the following AE substances:

 

CAS No.	EC No.	Substance	Study protocol	Hazard conclusion
68439-50-9	500-213-3	Alcohols, C12-14, ethoxylated	OECD 401	LD50 (rat, male/female) > 2000 mg/kg bw
68439-49-6	939-518-5	Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO	OECD 401	LD50 (rat, male/female) > 10000 mg/kg bw
9005-00-9	500-017-8	Octadecan-1-ol, ethoxylated	OECD 401	LD50 (rat, male/female) > 21000 mg/kg bw
66455-14-9	500-165-3	Alcohols, C12-13, ethoxylated	Similar OECD 401	LD50 (rat, male/female) > 2000 mg/kg bw
160901-19-9	500-457-0	Alcohols, C12-13, branched and linear, ethoxylated	Similar OECD 401	LD50 (rat, male) = 14865 mg/kg bw LD50 (rat, female) = 13627 mg/kg bw

 

Evaluation of acute oral toxicity as observed in studies

All available study results indicate a very low acute oral toxicity, thus demonstrating similar toxicological properties of the AE substances in regard to acute oral toxicity. The only sign of systemic toxicity was ruffled fur which was observed with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) at a dose of 10000 mg/kg bw. However, the effect ceased within 2 h post dosing. In all studies, animals showed the expected gain in bodyweight and no abnormalities were noted at the terminal necropsy of the animals. The LD50 values determined are consistently > 2000 mg/kg bw. Therefore, no / low acute oral toxicity and a LD50 > 2000 mg/kg bw is predicted for all substances in the AE category lacking acute oral toxicity data.

This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the acute toxicity of the substances in the AE category, please refer to the category justification attached to the category object.

 

Acute toxicity: inhalation

No data on acute toxicity via the inhalation route of exposure are available for AE substances as the inhalation route is considered less relevant than the dermal route.

 

Acute toxicity: dermal

No data on acute dermal toxicity are available for AE substances as none of the substances meets the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Justification for classification or non-classification

The available data on acute oral toxicity obtained with members of the Alcohol Ethoxylates (AE) category do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. Based on grouping of substances (category approach), (Z)-9-octadecen-1-ol ethoxylated (CAS No. 9004-98-2, EC No. 500-016-2) is predicted not to fulfil the classification criteria and is consequently not classified for acute oral toxicity.

No information on acute toxicity via the inhalation and dermal routes of exposure are available for AE substances because the inhalation route is considered less relevant than the dermal route and the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).