Registration Dossier

Administrative data

Description of key information

skin irritation (OECD 404): irritating
eye irritation (OECD 405): highly irritating/corrosive
SCLs according to GHS:
>=5% - <10% Eye Irrit. Cat.2
< 5% No Classification

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on skin and eye irritation/corrosion are available for AES (C12-14, 1-2.5 EO) NH4 (CAS 125301-88-4). Therefore this endpoint is covered by read across to structurally related AES, i.e. AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) for skin and eye irritation/corrosion, AES (C12-14, 1-2.5 EO) TIPA (CAS 174450-50-1) for skin irritation and AES (C10-16, 1-2.5 EO) Na (CAS68585-34-2) for eye irritation. The AES reported within the AES category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read across approach between structurally related AES. Within the HERA report (2003) it was concluded that “The skin irritating properties of AES normally decrease with increasing level of ethoxylation.” Therefore read across was performed to C12-14AES with an ethoxylation grade of 1 - 2.5 reflecting the chain length and ethoxylation grade of AES (C12-14, 1-2.5 EO) NH4 (CAS 125301-88-4). In addition, supportive data for AES (C10-16, 1-4 EO) Na (CAS68585-34-2) were evaluated.

There are two studies available addressing skin irritation for the read-across substances AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3) and AES (C12-14) TIPA (CAS 174450-50-1).

The study conducted with AES (C12-14) Na (CAS 68891-38-3, no data on ethoxylation grade) was performed according to OECD Guideline 404 under semi-occlusive conditions (Pels Rijcken, 1994). Each of three New Zealand White rabbits was exposed for 4 h to 0.5 g of the unchanged test item (analytical purity 70%) and was observed for a period of 21 days for erythema and edema. The mean erythema score (24, 48 and 72 h reading) and the mean edema score over all animals was 3.2, which fully reversed within the 21 days observation period. Thus the test substance was classified as skin irritating Category 2 according to Regulation 1272/2008/EC and R38 according to Directive 67/548/EEC.

The second study regarding skin irritation/corrosion was conducted on three Small White Russian rabbits with AES (C12-14; 2 EO) TIPA (CAS 174450-50-1) according to OECD Guideline 404 (Krueger, 1997b). Each of the rabbits was exposed for 4 h to 0.5 mL of the unchanged test item and was observed for a period of 14 days for erythema and edema. The mean erythema score (24, 48 and 72 h reading) over all animals was 2.3 and the mean edema score over all animals was 2.8, which fully reversed within the 14 days observation period. Thus, the test substance was classified as skin irritating Category 2 according to Regulation 1272/2008/EC and R38 according to Directive 67/548/EEC.

 

There are two studies available addressing eye irritation for the neat substance for the read-across substance AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3).

In the first study, 0.1 mL of unchanged AES (C12-14; 2 EO) Na (CAS 68891-38-3, analytical purity 28%) was applied to one eye of each of three rabbits similar to OECD guideline 405 (Mürmann, 1986). The observation period lasted 21 days. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 1.3, 0.8, 3 and 1. The corneal and the effects on the iris were not fully reversible within 21 days while conjunctival redness and chemosis fully reversed within the observation period. Thus the test substance produced severe eye damage at a concentration of 28%.

The second weight of evidence study with 0.1 mL of unchanged AES (C12-14) Na (CAS 68891-38-3, analytical purity 70%, no data on grade of ethoxylation) on New Zealand White rabbits according to OECD guideline 405 was only available as brief overview (Kreiling, 1988). Therefore the reliability of the study could not be assessed (RL4). Except for the duration of treatment (24 h) and the result (irritating, R41) no details are available.

As corrosion and irritation depends on the concentration of the substance in a solvent, further studies with lower concentrations of the test substance were also considered to assess whether specific concentration limits can be set. For this purpose, two studies with AES (C12-14; 4 EO) Na (CAS 68891-38-3) and two studies with AES (C10-16; 2 EO) Na (CAS68585-34-2) with an concentration range of 1 to 10% were evaluated.

 

One study was performed with 0.1 mL AES (C12-14; 4 EO) Na (CAS 68891-38-3, analytical purity 10%) similar to OECD guideline 405 (Kukulinski, 1980a) on three New Zealand White rabbits with an observation period of 7 days. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 1.6, 0.6, 2 and 1.6 representing an eye irritating effect of the test substance at a concentration of 10% . The effects were not fully reversed within the 7 days observation period. Therefore the test substance showed eye irritating potential.

The second study was performed with 0.1 mL AES (C12-14; 4 EO) Na (CAS 68891-38-3) similar to OECD guideline 405 (Kukulinski, 1980b) on three New Zealand White rabbits with an observation period of 7 days, however at an concentration of 5%. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 0.4, 0, 1 and 0.3. All effects reversed within the 7 days observation period. Thus, the test substance was not irritating to the eye at a concentration of 5%.

In a further supporting study with AES (C12-14; 2 EO) Na (CAS 68891-38-3, analytical purity 27%) according to OECD guideline 405, 0.1 mL of the test substance was applied to the rabbits eye at a concentration of 20% resulting in an actual concentration of 5.4% (Biffi, 1997).The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 0, 0, 1.2 and 0. The conjunctival redness reversed within the 7 days observation period. Thus the test substance was not irritating to eyes at a concentration of 5.4 %.

The supporting study with AES (C10-16) Na (CAS 68585-34-2, no data on grade of ethoxylation, analytical purity 58%) was performed similar to OECD guideline 405 (York, 1980).The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 0.7, 1, 3 and 3.3. All findings were fully reversible within the observation period. Thus, the test substance showed eye irritating properties at a concentration of 5%.

Based on the above mentioned results with different concentrations of structurally related alkyl ethersulfates a cut of value for classification as severe irritating to eyes is set at a concentration of 10% and for classification as irritating at a concentration of 5% for the AES of the category.

 

References:

Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28

HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject. com.


Justification for selection of skin irritation / corrosion endpoint:
Reliable OECD guideline study.

Justification for selection of eye irritation endpoint:
Scientifically reliable study conducted similar to OECD guideline.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance needs to be classified with Xi, R38/R41 and Skin Irrit. 2, H315 and Eye Dam.1, H318, respectively.

It could be shown with experimental data on eye irritation that at about 10% active substance only the classification Eye Irrit. Cat.2 remains and below 5% active substance no classification at all is necessary. Hence, the Generic Concentration Limits (GCLs) can be substituted by the mentioned specific ones (SCLs).

Due to the fact, that these SCLs comply with the generic ones set in Directive 1999/45/EC (DPD), SCLs will only be applied according to Regulation (EC) 1272/2008 (CLP).