tert-butyl 3-oxobutanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

The acute toxicity and primary irritancy potential of the test chemical

Author:

Bryan Ballantyne et.al

Year:

1986

Bibliographic source:

Drug and Chemical Toxicology, 1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To determine the primary dermal irritation potential of the test chemical in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pentane-2,4-dione

EC Number:

204-634-0

EC Name:

Pentane-2,4-dione

Cas Number:

123-54-6

Molecular formula:

C5H8O2

IUPAC Name:

2,4-Pentadione

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report):2,4-Pentandione- Molecular formula :C5H8O2- Molecular weight : 100.116 g/mol- Substance type:Organic- Physical state:Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Details on test animalTEST ANIMALS- Weight at study initiation: 2.0-3.0 kgENVIRONMENTAL CONDITIONS- Temperature (°C): 68-75 deg C- Humidity (%):30-65%- Photoperiod (hrs dark / hrs light): A 12 hr light-dark cycle was used in the animal accommodation rooms.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

1 hours and 1, 2,3,7, 14 days post instillation

Number of animals:

6

Details on study design:

Details on study designTEST SITE- Area of exposure: clipped dorsal skin- % coverage: no data available- Type of wrap if used: gauze and impervious polyethylene sheetingREMOVAL OF TEST SUBSTANCE- Washing (if done): yes- Time after start of exposure: after 4 hours of exposureSCORING SYSTEM: erythema and edema were scored by the method of Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

5 of 6 rabbits had a very slight local erythema, which also developed in the sixth animal by 24 hr. Edema, slight in 5 rabbits and moderate in one, was also present. After 3 days, only half the animals had just detectable erythema, and one had mild edema. Apart from mild desquamation, no effects were seen at 7 days.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

5 of 6 rabbits had a very slight local erythema, which also developed in the sixth animal by 24 hr. Edema, slight in 5 rabbits and moderate in one, was also present. After 3 days, only half the animals had just detectable erythema, and one had mild edema. Apart from mild desquamation, no effects were seen at 7 days.Since the effects were completely healed by 7 days, the test chemical can be considered to be not irritating to skin.

Executive summary:

A study was performed to determinethe primary dermal irritation potential of the test chemical in rabbits.

0.5 ml undiluted test chemical was applied to the clipped dorsal skin of 6 New Zealand White rabbits under occlusive wrapping for 4 hours. After 4 hours of exposure, the occlusive dressing was removed and the excess test chemical was gently removed. The test sites were inspected for erythema and edema at 1 hour, 1, 2, 3, 7 and 14 days post removal of the dressing. The dermal reactions were scored by the methods of Draize.

5of6rabbits had a very slight local erythema, which also developed in the sixth animal by 24 hr. Edema, slight in 5 rabbits and moderate in one, was also present. After 3 days, only half the animals had just detectable erythema, and one had mild edema. Apart from mild desquamation, no effects were seen at7days.

Since the effects were completely healed by 7 days, the test chemical can be considered to be not irritating to skin.