Registration Dossier
Registration Dossier
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EC number: 615-247-5 | CAS number: 71060-57-6
Endpoint summary
Administrative data
Description of key information
Oral (subacute, rat): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day
Read-across based on grouping of substances (category approach) considering all available data on subacute repeated dose toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category.
Oral (subchronic, rat): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day
Read-across based on grouping of substances (category approach) based on combined subacute repeated dose toxicity studies with the reproductive / developmental toxicity screening test (OECD 422) conducted with several member substances of the 'linear' subgroup of the AE category. Pursuant to compliance check final decision for a number of substances in the AE category, several subchronic repeated dose toxicity studies according to OECD guideline 408 are currently ongoing. The NOAEL for subchronic systemic toxicity established for the linear AE substances will be re-evaluated once the results of the OECD 408 studies are available.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose 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
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxicologically relevant effects observed
- Key result
- Critical effects observed:
- no
- Conclusions:
- Applying read-across based on grouping of substances (category approach), no toxicologically relevant effects after subacute repeated dose administration and a NOAEL for systemic toxicity ≥ 1000 mg/kg bw/day are predicted for the target substance.
- Executive summary:
The available data on repeated dose toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category indicates no toxicologically relevant effects 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 AE category are unlikely to lead to differences with respect to subacute repeated dose toxicity.
- Endpoint:
- sub-chronic 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
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxicologically relevant effects observed
- Key result
- Critical effects observed:
- no
- Conclusions:
- Applying read-across based on grouping of substances (category approach), no toxicologically relevant effects after subchronic repeated dose administration and a NOAEL for systemic toxicity ≥ 1000 mg/kg bw/day are predicted for the target substance.
- Executive summary:
The available data on repeated dose toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category indicates no toxicologically relevant effects 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 AE category are unlikely to lead to differences with respect to subchronic repeated dose toxicity.
Referenceopen allclose all
For a detailed assessment of the repeated dose toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.
For a detailed assessment of the repeated dose toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The available information comprises reliable (Klimisch score 1) studies from various source 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 data pool of the AE category is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Section 8.6, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Subacute repeated dose toxicity
No data on subacute repeated dose toxicity of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are available. In order to assess repeated dose toxicity, studies in the data pool of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. Due to differences in systemic toxicity between AE substances containing only linear constituents and those containing linear and branched constituents, as observed in studies with repeated dose administration, only data obtained with AE substances in the 'linear' subgroup of the category are used to read-across systemic endpoints, incl. repeated dose toxicity, to AE substances containing only linear constituents. Adequate and reliable studies are available for the following linear AE members:
- Alcohols, C10, ethoxylated, < 2.5 EO (CAS No. 26183-52-8, EC No. 500-046-6): (OECD 422) Parental systemic NOAEL ≥ 1000 mg/kg bw/day
- Alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3): (OECD 422) Parental systemic NOAEL ≥ 1000 mg/kg bw/day
- Hexadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-95-9, EC No. 500-014-1): (OECD 422) Parental systemic NOAEL ≥ 1000 mg/kg bw/day, local NOAEL = 300 mg/kg bw/day
- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): (OECD 422) Parental systemic NOAEL ≥ 1000 mg/kg bw/day
- (Z)-9-Octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2): (OECD 422) Parental systemic NOAEL ≥ 1000 mg/kg bw/day
Conclusion
All available study results indicate a very low systemic toxicity, thus demonstrating the similarity of the linear AE substances with respect to systemic toxicological properties. Treatment with the substances was generally well tolerated and no treatment-related mortality ocurred in any study. Moreover, treatment did not cause any toxicologically relevant changes in relation to functional observations, body weight and food consumption, estrous cycle and measurement of thyroid hormones. Histopathological observations, e.g. hepatocellular hypertrophy and vacuolation in the lamina propria of the jejunum, were considered non-adverse due to minimal severity and the absence of any degenerative findings. Due to squamous cell hyperplasia and (lympho)granulacytic infiltration in the glandular stomach (forestomach) observed in the study with hexadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-95-9, EC No. 500-014-1), for this substance a local NOAEL of 300 mg/kg bw/day was derived additionally to a systemic NOAEL. The systemic NOAEL values determined in all studies are consistently ≥ 1000 mg/kg bw/day, i.e. the highest dose tested. Therefore, a NOAEL ≥ 1000 mg/kg bw/day is used for the hazard assessment and classification and labelling of the linear AE substances, incl. alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5). For a detailed assessment of the repeated dose toxicity of the linear AE member substances, please refer to the category justification attached to the category object.
Subchronic (90-day) repeated dose toxicity
No data on subchronic repeated dose toxicity of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are available. In order to assess subchronic repeated dose toxicity, studies in the data pool of the AE category will be considered. Pursuant to final compliance check decision for a number of substances in the AE category, several subchronic repeated dose toxicity studies according to OECD guideline 408 are currently ongoing. Until results of these studies will be available, a NOAEL of ≥ 1000 mg/kg bw/day for systemic toxicity as determined in the combined subacute repeated dose toxicity studies with the reproductive / developmental toxicity screening test performed with the linear AE substances listed above is considered as the subchronic NOAEL and used for the hazard assessment and the evaluation of classification and labelling of the linear AE substances. The NOAEL for subchronic systemic toxicity will be re-evaluated once the results of the OECD 408 studies are available. For a detailed assessment of the repeated dose toxicity of the AE category, please refer to the category justification attached to the category object.
Justification for classification or non-classification
The available data on repeated dose toxicity obtained with members of the 'linear' subgroup 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), alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) is predicted not to fulfil the classification criteria and is consequently not classified for Specific Target Organ Toxicity after Repeated Exposure (STOT RE).
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