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Description of key information

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

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Remarks:
no data
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Eye irritation of allyl bromide is cited in a general handbook on product safety data
Guideline:
other: No data
GLP compliance:
not specified
Irritation parameter:
other: No data
Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Based on this handbook allyl bromide cause severe eye burns
Executive summary:

Based on this handbook allyl bromide cause severe eye burns

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:
Only one study available

Justification for selection of eye irritation endpoint:
This handbook contains the most important effect of allyl bromide on eyes

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Under experimental conditions, allyl bromide need to be classified as "Skin Corr. 1B" and assigned the hazard phrase "H314 Causes severe skin burns and eye damage" in accordance with the CLP regulation.