Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating 
Eye irritation (OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A voluntary industry programme to carry out Human and Environmental Risk Assessments on ingredients of household cleaning products (HERA) evaluated the irritation potential of AEs. According to HERA the irritation potential is decreasing with increasing ethoxylation degree. The lower ethoxylation level of EO 1 - 3, which includes all substances of the category, appeared to be more irritating (HERA, 2009). Since the category chemicals differ mainly from each other only by the number of -CH2- units (except for the unsaturated group), the category is very homogenous and it is assumed that each category member exhibits the same toxic mode of action.

Based on weight of evidence and interpolation on the given study reports the following subcategories for skin irritation can be derived:

Class I:          short chain AEO (C6-11) → not classified for skin irritation 

Class II:         detergent grade AEO (C12-15) → not classified for skin irritation

Class III:        saturated long chain AEO (C16-18) → not classified for skin irritation

Class IV:        unsaturated long chain AEO (C16/18 and C18 unsatd.) → H315

For further details please refer to the category justification. Exemplary study summaries are provided for the skin and eye irritating potential of C18AE.

A study comparable to OECD Guideline 404 with C18AE (CAS 9005-00-9) assessed the irritating potential to the skin (Croda, 1975). Six albino rabbits were exposed for 24 h to 0.5 mL test substance under semiocclusive conditions and observed for subsequent 72 h. Mean erythema and oedema scores over all animals within three days were 0, whereas no 48 h score is available. For calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

 

Regarding eye irritation, the test substance does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). This result is in line with the outcome of a trend analysis performed for eye irritating properties of the members of the AE Category to evaluate the impact of carbon chain length distribution on the eye irritating properties. All available studies, performed according to OECD Guideline 405 under GLP conditions, applying AE of a high purity (> 95%) and an ethoxylation degree ≤ 2.5 and allowing the evaluation of the recovery (until day 21), were evaluated. According to this evaluation AE of the AE Category having a carbon chain length ≥ C12 do not need to be classified for eye irritation/severe eye irritation. Based on this analysis C18 AE (CAS 9005-00-9) is not classified for eye irritation. For further information please refer to the category justification.

A study regarding the eye irritating potential of C18AE (CAS 9005-00-9, ethoxylation degree 2) was performed similar to OECD Guideline 405 (Croda, 1963) with New Zealand White rabbits. Six animals were treated with 0.1 mL of an aqueous solution of test item (60%) and eye reactions were scored 1, 2, 3, 4, 7, 10 and 14 days after instillation. The mean 24, 48 and 72 h cornea, iris, conjunctivae and chemosis scores of six rabbits were 0, 0, 0.4 and 0.5, respectively. All effects were fully reversible. Therefore, aqueous solutions of 60% C18AE were not eye irritating under the conditions of the study.

A further eye irritation study with C18AE (CAS 9005-00-9, ethoxylation degree 2, purity > 99%) was performed with six albino rabbits similar to OECD Guideline 405 (Croda, 1975). The rabbits were treated with the test substance without washing. The eyes were examined 24, 48 and 72 h and 7 days after test substance application. One animal showed conjunctival redness (grade 1) at the 24, 48 and 72 h reading time point, which resolved within 7 days. No further reactions were noted in any of the animals. Thus the test material is not considered to be irritating to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
Reliable Guideline study chosen.

Justification for selection of eye irritation endpoint:
Hazard assessment is based on the weight of evidence from relevant studies.

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.