Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August to October 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiences, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Description: yellow liquid
Storage conditions: at room temperature, protected from light
Purity: > 98.5%
pH measured at the C.I.T. was 1.7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Number of animals: 3 animals were used
Weight: on the day of treatment, the animals had a mean body weight of 2.6±0.3 kg
Acclimatization: at least 5 days before the beginning of the study
Selection of the animals: the days before treatment, the skin of each animal was examined in order to use only animals without any signs of cutaneous irritation
During the acclimatization period and during the main test, the environmental conditions in the animal room were set as follows:
- temperature: 18±3°C
- relative humidity: 50±20%
- light/dark cycle: 12h/12h
The animals were housed individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm).
Each cage was equipped with a food container and a water bottle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: The opposite flank of each animal was used for control
Amount / concentration applied:
A dose of 0.5 mL of the test substance was applied to a 6 cm2 dry hydrophilic gauze patch and this was then applied to one flank of the animals.
The test substance and the gauze patch were held in contact with the skin by means of an adhesive hypoallergic aerated semi-occlusive dressing and a restraining bandage.
Duration of treatment / exposure:
First test with 3 minutes exposure and 2nd tests with 4 hours exposure.
The dressings were removed and no residual test substance was observed.
The animals were then replaced into their individual cages.
Observation period:
The skin was examined approximately 1, 24, 48 and 72 hours after removal of the dressing.
As there was persistent cutaneous irritation after 72 hours, the observation period was extended to day 15.
Number of animals:
3 : 1 for the 3 minutes test and 2 for the 4 hours tests
Details on study design:
As the test substance was anticipated to be irritant, a preliminary assay was conducted with an application of the test substance for 3 minutes in animal nb 1 and 4 hours in animal nb 2.
A second application was performed for 4 hours using animal nb 3.
Results from the 4 hour exposure are included in the analysis.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
2.5
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 d
Score:
2.5
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 d
Score:
3.5
Max. score:
4
Irritant / corrosive response data:
On day 6 necrosis of the skin was noted in one animal.
A crust persisted between days 6 and 15 in the second animal.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, allyl bromide was determined as corrosive when administrated by cutaneous route for a period of 4 hours in rabbits
Executive summary:

The skin irritation potential of allyl bromide was determined according to the following guideline, OECD 404.

Two rabbits were exposed to 0.5 mL of the test material for 4 hours. The area was then observed at intervals over a period of 15 days. The test material was determined as corrosive.

Under CLP regulation the test material should be classified as "Skin Corr. 1B" and assigned the hazard phrase "H314 Causes severe skin burns and eye damage".