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

To cover the endpoint irritation of substance C16AE (CAS 52609-19-5), studies from similar substances were taken into account. 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. 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 attached in IUCLID section 13.

Exemplary study summaries are provided for the skin and eye irritating potential of C16/18 AE.

 

To assess the eye irritating potential of AEs with longer carbon chain length, a read-across from a study with C16-18 (CAS 68439-49-6) was performed (Sasol, 1986c). The study was conducted according to OECD 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.

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 C16AE (CAS 52609-19-5) is not classified for eye irritation. For further information please refer to the category justification.


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

Justification for selection of eye irritation endpoint:
Reliable Guideline study chosen.

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.