Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
26 March to 9 April 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocol, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
EC Number:
603-094-7
Cas Number:
125904-11-2
Molecular formula:
C8 H6 Br2
IUPAC Name:
Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: young adult
- Weight at study initiation: 2087 to 2399 g
- Housing: individual suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow # 5322 ad libitum
- Water: tap water from on-site wells ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 70-73 Fahrenheit degrees
- Humidity: 40-66%
- Photoperiod: 12 hours light/12 hours dark

IN-LIFE DATES: from 26 March to 9 April 1987

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6 (3 males and 3 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: fissuring present on days 4 and 5 and desquamation observed from day 6 to 14
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: fissuring present on days 4 and 5; desquamation observed on days 6 to 13
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: desquamation observed on days 5 to 13
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: desquamation observed from day 5 to 14
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritant / corrosive response data:
The test substance was considered to be a moderately irritating substance based on a PII (primary irritation index calculated with 24 and 72 hours values) of 4.1.
According to the EU criteria, the test substance is classified as a skin irritant and labelled with R38
Other effects:
fissuring and desquamation were observed in most animals

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
Irritating to the skin - R38
Executive summary:

In a primary skin irritation study, 0.5 mL of undiluted test substance were applied to the intact shaved skin of 6 rabbits. Significant inflammation of the skin was observed. The test substance was therefore considered to be a skin irritant and should be labelled with R38.