Alcohols, C16-18, ethoxylated, phosphates

Endpoint summary

Description of key information

Skin irritation (according to OECD 431 and 439; tiered testing strategy): not irritating to skin
Eye irritation (according to OECD 437, GLP): causes severe damage to eyes (Cat 1; H318)

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:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

One vitro study on skin corrosion is available for Alcohols, C16-18, ethoxylated, phosphates (CAS 106233-09-4), which was performed according to OECD 431 (In vitro skin corrosion: human skin model test) and in compliance with GLP.

The test substance (20 mg) was applied to an intact reconstructed human epidermis (purchased as EPISKIN^TM) for 3, 60, and 240 min (each in duplicate cultures). After the incubation the skin surface was washed and the cell viability of the tissue was assessed by MTT reduction assay. A viability of 92.3, 79.5, and 67.9% was observed after the 3, 60, and 240 min exposure time, respectively. The negative and positive controls complied with the acceptance criteria. Therefore the test substance was considered as non-corrosive, as the viability was ≥35% (criteria for non-corrosivity).

Furthermore, an in vitro skin irritation study with Alcohols, C16-18, ethoxylated, phosphates (CAS 106233-09-4) is available, which was performed according to OECD 439 (in vitro skin irritation).

The test substance (10 mg) was applied to an intact reconstructed human epidermis (purchased as EPISKIN^TM) for 15 min (in triplicate cultures). After the incubation the skin surface was washed and the cell viability of the tissue was assessed by MTT reduction assay after a 42 h post-exposure period. A viability of 94.4% relative to the negative control was observed. The negative and positive controls complied with the acceptance criteria. Therefore the test substance was considered as non-irritant, as the viability was > 50%.

 

Eye irritation:

A study identifying ocular corrosives and severe irritants is available for Alcohols, C16-18, ethoxylated, phosphates (CAS 106233-09-4), which was performed according to OECD 437 (Bovine Corneal Opacity and Permeability Test Method) and in compliance with GLP.

The test substance was applied as a 20% solution on the cornea dissected from a cattle eye for 4 h (three corneas per group). After the incubation the epithelium was washed and the opacity and permeability was assessed. The corneas were retained after testing for possible conduct of histopathology. Macroscopic examination of the corneas revealed a clear, cloudy, and slightly cloudy appearance of the negative control, positive control, and the test substance group corneas, respectively. The In-vitro Irritancy Score (IVIS) was 4.6, 90.3, and 105.8 for the negative control, positive control, and the test substance group, respectively. Thus, the test substance was considered to be a severe irritant/corrosive (criteria for irritancy/corrosivity: IVIS ≥ 55.1).

 

Justification for selection of skin irritation / corrosion endpoint:
No selection was made as 2 key studies are available. A tiered testing strategy approach according to OECD 404 (adopted 2002) was applied.

Justification for selection of eye irritation endpoint:
Most reliable study. Equivalent to OECD guideline and in accordance with GLP.

Effects on eye irritation: corrosive

Justification for classification or non-classification

The available data on skin irritation of the test substance do not meet the criteria for classification according to regulation (EC) 1272/2008 and to Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

The available data on eye irritation of the test substance meet the criteria for classification as 'Causes serious eye damage: Cat 1' (H318) according to regulation (EC) 1272/2008 and as "Risk of serious damage to eyes" (R41) according to Directive 67/548/EEC.