Ethyl 4,4,4-trifluoroacetoacetate

Endpoint summary

Description of key information

SKIN IRRITATION:
A study was carried out according to EU Method B.4 and OECD Guideline 404. Six NZW female rabbits were used in this study and treated with 0.5 ml test item. Slight skin reactions were noted in all animals, however they were found to be reversible within 72 hours. Therefore, P5117 is considered to be not irritating to rabbit skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, non-GLP

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull HU11 4QE
- Age at study initiation: 11 weeks
- Weight at study initiation: weight range 2.80-3.67 kg
- Housing: individually
- Diet (e.g. ad libitum): Standard Rabbit Diet, B.P. Nutrition (UK) Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 changes/hr
- Photoperiod (hrs dark / hrs light): 14 hours artificial light

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml test item

Duration of treatment / exposure:

4 hours

Observation period:

4, 24, 48 and 72 hours after treatment

Number of animals:

6 female rabbits

Details on study design:

Twenty four hours prior to treatment, the back of each animal was clipped free of hair using veterinary clippers (Model A2, Oster, Milwaukee, Wisconsin). The left side of the clipped area on each animal was left intact. The right side was abraded using a clipper head to penetrate the horny layer of the epidermis, but without causing bleeding or damage to the underlying dermis. Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm). A small plug of cotton wool weighing approximately 1 g was placed over the top of the pads to achieve uniform pressure over the whole treated surface. The pads were held in place by a strip of adhesive impermeable plaster, (Sleek,Smith and Nephew Ltd., Welwyn Garden City Herts). A polypropylene collar was placed around the neck of each animal to prevent removal of the wrapping. Four hours after treatment the wrappings and collars were removed.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

score of six animals

Time point:

other: 24, 48 and 72 h

Score:

0.2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

mean

Remarks:

score of six animals

Time point:

other: 24, 48 and 72 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

score of six animals

Time point:

other: 24, 48 and 72 h

Score:

1.2

Irritant / corrosive response data:

A primary irritation index of 1.2 was obtained. The test article was classified as a mild skin irritant. Redness, assessed as very slight to well-defined, was noted in all rabbits at some time during the observation period. All skin reactions regressed and all skin sites, with the exception of 2 abraded sites which showed very slight redness, appeared normal at the 72 hour observation. P5117 did not produce a corrosive response as defined by the Code of Federal Regulations, Title 49, Part 173, 1976.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was found to be slightly irritating to rabbit skin, however it can be classified as non-irritant.

Executive summary:

A study was carried out according to EU Method B.4 and OECD Guideline 404. Six NZW female rabbits were used in this study and treated with 0.5 ml test item. Slight skin reactions were noted in all animals, however they were found to be reversible within 72 hours. Therefore, P5117 is considered to be not irritating to rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Klimisch 2 guideline study, non-GLP

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).