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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-3-chloropropane
EC Number:
203-697-1
EC Name:
1-bromo-3-chloropropane
Cas Number:
109-70-6
Molecular formula:
C3H6BrCl
IUPAC Name:
1-bromo-3-chloropropane
Details on test material:
Batch number : 9207093
Expiry : stable for at least three months
Purity : 99,6%
Appearence : colourless liquid
Storage conditions : room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three healthy adult rabbits, in the weight range 2,4 to 2,8 kg, aged 10 to 13 weeks. The rabbits were selected without conscious bias for the study.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70 %. These environmental parameters were recorded daily. Air exchange was maintened at approximately 19 air changes per hour and lighting was controlled by means of a time switch to provide 12 hours of artificial light (07:00-19:00 hours) in each 24 hours period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,5 ml of the test substance
Duration of treatment / exposure:
4-hour period
Observation period:
5 days
Number of animals:
3
Details on study design:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
A 0,5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for a four hours period. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dresisng and gauze pad were removed and the treatment site was washed with warm water (30° to 40 °C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 1 (30 minutes)
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 2
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 3
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 4
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 5
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 1 (30 minutes)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 2
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 3
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 4
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 5
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema with or without very slight oedema was observed in two animals 24 hours after the removal of the dressings.
Well-defined erythema accompanied by very slight oedema was seen in all animals on day 3. These reactions had ameliorated slightly by day 4, when very slight erythema and oedema was observed in all animals.
All reactions had resolved by day 5.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of 1-bromo-3-chloropropane to intact skin for four hours elicted very slight to well-defined dermal reactions. All reactions had resolved on day 5.
Since the 3 criteria contained in the table 3.2.2 of the annex 1 of the regulation 1272/2008 are not fulfilled, 1-bromo-3-chloropropane does not require labelling concerning skin irritation in accordance with the CLP regulation.