Alcohols, C8-10, ethoxylated

Endpoint summary

Description of key information

Skin irritation / corrosion: corrosive

Read-across based on the trend from corrosive (C8 substances) to non-irritant (C10-C12 substances) observed in the Alcohol Ethoxylates (AE) category for substances containing only saturated constituents.

Eye irritation / serious eye damage: serious eye damage

A study for eye irritation / serious eye damage is not required for alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) according to the REACH Regulation (EC) No. 1907/2006, Annex VII, Section 8.2, Column 2, because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

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.

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min exposure

Remarks on result:

other: Corrosive based on available skin irritation / corrosion data in the Alcohol Ethoxylates (AE) category.

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min exposure

Remarks on result:

other: Corrosive based on available skin irritation / corrosion data in the Alcohol Ethoxylates (AE) category.

For a detailed assessment of the skin irritation / corrosion potential of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.

Interpretation of results:

other: Skin corr. 1, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).

Conclusions:

Applying read-across based on grouping of substances (category approach), skin corrosion is predicted for the target substance.

Executive summary:

The available data on skin irritation / corrosion in the Alcohol Ethoxylates (AE) category indicate skin corrosion 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 in the skin irritation / corrosion potential.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

No data on skin irritation / corrosion of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are available. In order to assess skin irritation / corrosion, studies in the data pool of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. As opposed to endpoints related to systemic toxicity, all AE substances contribute to the data used for read-across of local endpoints, incl. skin irritation / corrosion. Adequate and reliable studies investigating skin irritation within the AE category are available for the following category member substances:

- Octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1): corrosive in vitro (OECD 431)

- Alcohols, C10, ethoxylated, < 2.5 EO (CAS No. 26183-52-8, EC No. 500-046-6): not irritating in vivo (OECD 404)

- Alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3): severely irritating under occlusive conditions in vivo (similar OECD 404)

- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): not irritating in vivo (OECD 404)

- Alcohols, C16-18 and C18 unsatd., ethoxylated, < 2.5 EO (CAS No. 68920-66-1, EC No. 500-016-2): irritating in first in vivo study (OECD 404) and not irritating in second in vivo study (OECD 404)

- Octadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9005-00-9, EC No. 500-017-8): not irritating in vivo (similar OECD 404)

- Alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3): not irritating in vivo (similar OECD 404)

- Alcohols, C12-13, branched and linear, ethoxylated, < 2.5 EO (CAS No. 160901-19-9, EC No. 500-457-0): not irritating in vivo (similar OECD 404)

- Alcohols, C12-15, branched and linear, ethoxylated, < 2.5 EO: not irritating in vivo (similar OECD 404)

Conclusion

Most of the available study results for AE substances with a carbon-chain length ≥ C10 containing only fully saturated constituents indicate a generally low irritating potential. Edema and erythema formation (if any) is slight to moderate and mean edema and erythema scores are below the threshold for classification according to the criteria of the CLP Regulation (EC) No. 1272/2008. All skin reactions (if any) are fully reversible within the observation period of the respective study. The exception is the findings of the study with alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3). The reason for the severely irritating result of the latter study might be the occlusive coverage applied in this study. Exposure to a test material under occlusive conditions is significantly higher than under semiocclusive conditions which is the standard in the current OECD 404 test guideline. It is reasonable to assume that higher exposures will most likely result in more severe effects. Hence, the results of the study over predict the irritation potential of alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3) when assessed against new OECD 404 criteria.

Based on all available data on skin irritation / corrosion in the AE category, it is established that the study with alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3) should be regarded as an outlier most probably related to methodological deviations. The study is not considered in the assessment of the skin irritation potential of the substances in the AE category. Furthermore, the length of the alkyl chain if ≥ C10 does not exert any influence on the skin irritation potential of AE substances. Members of the AE category containing only saturated constituents are generally not irritating to skin, irrespective of their carbon-chain length if it is ≥ C10.

The general trend is, however, not observed for octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) with a carbon-chain lenght of C8 and alcohols, C16-18 and C18 unsatd., ethoxylated, < 2.5 EO (CAS No. 68920-66-1, EC No. 500-016-2) which revealed a corrosive and irritating potential, respectively, in appropriate experimental investigations. For these AE substances it is concluded that the hazard assessment and conclusion on classification and labelling has to be based on their own data rather than on the evaluation of all data available in the AE category. Since alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) contains a substantial amount of constituents with a carbon-chain length < C10, similar to octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1), a corrosive potential is also predicted for alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) in a worst-case approach. This prediction is in contrast to the low irritation potential observed for AE substances with carbon-chain lengths ≥ C10. Moreover, since no additional studies with AE substances containing unsaturated constituents are available, a skin irritating potential is assumed for alcohols, C16-18 and C18 unsatd., ethoxylated, < 2.5 EO (CAS No. 68920-66-1, EC No. 500-016-2) and (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2) in a worst-case approach.

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

Eye irritation / serious eye damage

Data on eye irritation / serious eye damage of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are not required because the substance is classified as corrosive to skin, leading to classification as serious eye damage (Category 1). Although legally not required, eye irritation is discussed here based on studies available in the data pool of the AE category. Adequate and reliable studies investigating eye irritation / serious eye damage are available for the following AE substances:

- Alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3): not irritating in first in vivo study (OECD 405) and corrosive in second in vivo study (OECD 405, but only 1 animal tested)

- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): not irritating in vivo (OECD 405)

- Alcohols, C16-18 and C18 unsatd., ethoxylated, < 2.5 EO (CAS No. 68920-66-1, EC No. 500-016-2): not irritating in first in vivo study (OECD 405) and not irritating in second in vivo study (OECD 405)

- Octadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9005-00-9, EC No. 500-017-8): not irritating in first in vivo study (similar OECD 405) and not irritating in second in vivo study (similar OECD 405, but only 60% purity of test material reported)

- Alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3): not irritating in vivo (similar OECD 405)

- Alcohols, C12-13, branched and linear, ethoxylated, < 2.5 EO (CAS No. 160901-19-9, EC No. 500-457-0): not irritating in vivo (similar OECD 405)

Conclusion

All available study results indicate a generally low irritating potential of the AE substances towards the eye. Effects observed (if any) on corneal opacity, iridial and conjunctival irritation as well as chemosis are mainly mild and fully reversible within the observation period of the respective study. The mean scores determined in the studies are below the threshold for classification according to the criteria of the CLP Regulation (EC) No. 1272/2008. Only one study performed with alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3) resulted in irreversible effects indicating a potential to cause serious eye damage. However, in this study only one animal was used and it is the only study, out of the nine available studies, contradicting the general trend within the AE category. Based on all available experimental data on eye irritation in the AE category, it is therefore concluded not to consider the single study on only one animal demonstrating a potential for serious eye damage. Excluding this study, it is established that the length of the alkyl chain and the presence of unsaturated constituents do not exert any influence on the eye irritation potential of AE substances. However, experimental data regarding eye irritation for category members with a carbon-chain length < C12 are not available. Therefore, the eye irritation potential of AE member substances is also assessed based on the CESIO recommendation for the harmonised classification and labelling of surfactants (CESIO: the European Committee of Organic Surfactants and their Intermediates; www.cesio.eu/index.php/policy-legislation/classification-labelling). The CESIO approach also considers AE substances which are not members of the AE category, thus increasing the database for assessing the eye irritation potential.

In summary, adequate and reliable studies performed with category member substances (with ≥ C12) in combination with the CESIO recommendation for AE member substances with < C12 allow to conclude that category member substances containing at least one constituent with alkyl chain lengths < C12 exhibit an eye irritation potential whereas AE substances containing only constituents with an alkyl chain length of ≥ C12 are not irritating to the eye.

As mentioned above, alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) is a special case with respect to eye irritation because it is classified as skin corrosive. Thus, an individual, substance-specific approach is chosen for hazard assessment and classification and labelling purposes. As a result of the classification for skin corrosion, the substance needs also to be classified for serious eye damage. For a detailed evaluation of the eye irritation potential of the substances in the AE category, please refer to the category justification attached to the category object.

Justification for classification or non-classification

Alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) is classified as skin corrosion in a read-across approach based on grouping of substances (category approach) considering all available relevant data in the Alcohol Ethoxylates (AE) category. As a result of the classification for skin corrosion, the substance needs also to be classified for serious eye damage according to the provisions of the CLP Regulation (EC) No. 1272/2008. In conclusion, alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) is therefore classified as Skin Corr. 1 and Eye Damage 1 (H314).