Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6)


Eye irritation (OECD 405): not irritating

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Source, key, 68439-49-6, 1986b
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Source, key, 68439-49-6, 1986b
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Based on read-across data, the target substance is not expected to be irritating to skin.
Executive summary:

The skin irritation / corrosion potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). Exposure for 4 h of the test substances to the shaved skin of rabbits under occlusive conditions resulted in slight erythema formation. Effects were fully reversible within 14 days. No edema were observed at any time in the study. Therefore, based on read-across, for the target substance no hazard regarding skin irritation / corrosion is expected. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin irritation / corrosion potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Source, key, 68439-49-6, 1986c
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Source, key, 68439-49-6, 1986c
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Source, key, 68439-49-6, 1986c
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Source, key, 68439-49-6, 1986c
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Based on read-across data, the target substance is not expected to be an eye irritant.
Executive summary:

The eye irritation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). Application of the unchanged test substance to the eyes of rabbits resulted in no effects regarding corneal opacity, iridial, conjunctival and chemosis responses. The mean scores of all effects at 24/48/72 h over all animals was 0. Therefore, based on read-across, for the target substance no hazard regarding eye irritation / severe eye damage is expected. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the eye irritation potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

No data regarding skin irritation / corrosion are available for C16AE (CAS 9004-95-9). Therefore, the skin irritating potential was addressed using reliable data as available from the structurally-related substance C16-18AE (CAS 68439-49-6) for read-across. The study (Sasol, 1986b) was conducted according to OECD Guideline 404. Three albino rabbits were exposed for 4 h to 0.5 mL test substance under occlusive conditions and observed for subsequent 14 days. Mean 27/48/72 h erythema and oedema scores over all animals were 0.3 and 0, respectively. Erythema was fully reversible.

 

Eye irritation / severe eye damage

No data regarding eye irritation / sever eye damage are available for C16AE (CAS 9004-95-9). Therefore, the eye irritating potential was addressed using reliable data as available from the structurally-related substance C16-18AE (CAS 68439-49-6) for read-across. The study (Sasol, 1986c) was conducted according to OECD Guideline 405. Three rabbits were treated with 0.1 mL of undiluted test substance for 72 h until the exposed eyes were washed with lukewarm physiological sodium chloride solution. No irritating effects were noted.

 

For the endpoint eye irritation, no clear structure-activity relationship has been observed in the HERA-Report of alcohol ethoxylates (2009). Undiluted products induced response from non-irritating to severely irritating. From eye irritation study data submitted to CESIO (CESIO recommendations for Anionic and Non-ionic surfactants), classification as Eye damage, Cat. 1 (H318), is recommended for alcohol ethoxylates with a carbon chain length below C14 and an ethoxylation degree below 15. For carbon chain length ≥ C14 - < C18 classification as Eye irrit., Cat. 2 (H319), shall be applied independently of the ethoxylation degree. All alcohol ethoxylates with a carbon chain length ≥ C18 should not be classified as eye irritating.

Combining the CESIO recommendation and the available eye irritation data with C16-18AE (CAS 68439-49-6) it is obvious that also C16AE (CAS 9004-95-9) does not need to be classified for eye irritation.

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP), the test substance does not need to be classified for skin and eye irritation.