Ethyl 4-chloroacetoacetate

Endpoint summary

Description of key information

Skin irritation/corrosion

A study was carried out according to EU Method B.4 and OECD Guideline 404 (acute dermal irritation) on three Albino rabbits. Sicne the test item was expected to produce severe skin effects, exposure periods of 3 minutes, 1 hour and 4 hours were exsamined. When applied for 4 hours, the test substance caused moderate erythema, severe haemorrhages, moderate (black) incrustation, and severe oedema in the one rabbit treated. At l4 and 2l days atler treatment, scar tissue was observed.When applied for 1 hour, the test substance caused moderate erythema, slight haemorrhages (one rabbit), slight incrustation, and severe oedema in the three rabbits treated. At 21 days after treatment, scar tissue was observed in one rabbit and decreased hair growth in the other two rabbits. When applied for 3 minutes, the test substance caused well-defined or moderate erythema and severe oedema in the three rabbits trcated. At 2l days after treatment, all skin effects had cleared completely. 3. On the basis of the results obtained under the conditions of this study and according to the EC-standards, it was concluded that:

- P0026 is irritating, but not corrosive after a 3-min exposure period,

- P0026 is irritating and corrosive after a 1 -hour exposure period, and

- P0026 is irritating and corrosive after a 4-hour exposure period.

Eye irritation/corrosion

The test item was examined for eye irritating/corrosive potential in an ex vivo bioassay, namely the Enucleated Eye Test with chicken eyes (GEET). The chicken eyes were obtained from slaughter animals for human consumption. The sample caused severe corneal swelling, moderate to severe corneal opacity and moderate fluorescein retention of damaged corneal epithelium in the test eyes. On the basis of the results obtained with this ex vivo bioassay and according to the CEET scheme for (EC-)classification applied, it was concluded that the substance was severely irritating to eyes. In addition, a subsequent in vivo dermal toxicity study with rats and a sensitization study with guinea pigs also showed skin corrosivity by the test substance. It was therefore, decided not to carry out the in vivo eye irritation test with rabbits but to consider the test substance causing serious damage to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of the two studies, the test item needs to be classified as follows:

Skin corrosion cat.1B - H314: Causes severe skin burns and eye damage