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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

Two studies investigating the skin irritating properties of AES (C8-10) Na are available while no data on eye irritating properties of AES (C8-10) Na are available. As worst case scenario AES (C8-10) Na is classified according to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 as Xi, R41 and Eye Dam.1, H318, respectively. However, to assess specific concentration limits (SCL) for eye irritation a read across to structurally related AES, i.e. AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) and AES (C10-16, 1-2.5 EO) Na (CAS68585-34-2) was performed. 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 [1] and HERA [2], supporting the read across approach between structurally related AES. Within the HERA report [2] it was concluded that “The skin irritating properties of AES normally decrease with increasing level of ethoxylation.” Therefore read across was performed to AES with an ethoxylation grade of 1 - 2.5 reflecting the ethoxylation grade of AES (C8-10) Na.

 

There are two studies available addressing skin irritation.

The first in vitro study was performed according to OECD Guideline 431 to assess the skin corrosive potential of AES (C8-10, 2 EO) Na . 25 mg of the test substance was applied atop an EpiDerm ™ tissue, comprising of a reconstructed epidermis with a functional stratum corneum, for 3 and 60 minutes (Lehmeier, 2012). The viability of the treated tissue, as assessed via the MTT assay, was 84% of control after 3 min exposure and 48% of control after 60 min exposure period. Thus, AES (C8-10, 2 EO) Na was not corrosive.

The second study was performed according to OECD Guideline 439 with AES (C8-10, 2 EO) Na. 25 mg of the test substance was applied atop an EpiDerm ™ tissue, comprising of a reconstructed epidermis with a functional stratum corneum, for 60 minutes (Lehmeier, 2012). The viability of the treated tissue, as assessed via the MTT assay, was 7% of control after 60 min exposure. Thus, AES (C8-10, 2 EO) Na was irritating.

Data on eye irritation:

As worst case scenario AES (C9-11)NH4 (CAS 160901-27-9) is classified according to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 as Xi, R41 and Eye Dam.1, H318, respectively.

However, 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 a 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 supporting study with AES (C10-16, 2 EO) Na ( CAS 68585-34-2, 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 second 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 ether sulfates 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

[1] Danish EPA, Environmental Project No. 615, (2001),
http://www2.mst.dk/udgiv/publications/2001/87-7944-596-9/pdf/87-7944-597-7.pdf

[2] (HERA report, 2003),
http://www.heraproject.com/files/1-HH-04-HERA%20AES%20HH%20web%20wd.pdf


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

Justification for selection of eye irritation endpoint:
Worst case assumed

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.

It could be shown with experimental data on eye irritation that below 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).