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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 October 1996-1 November 1996
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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:
4-bromoanisole
EC Number:
203-252-1
EC Name:
4-bromoanisole
Cas Number:
104-92-7
Molecular formula:
C7H7BrO
IUPAC Name:
4-bromoanisole

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A local supplier to the testing laboratory
- Age at study initiation: at least 12 to 16 weeks old
- Weight at study initiation:2.30 to 2.76 kg
- Housing: in suspended metals cages.
- Diet :Free access to food (SRANRAB SQC Rabbit Diet)
-Water: Free access to water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
Room temperature: 17-20oc
Relative humidity: 45-70%
air exchange rate: 15 changes per hour, 12 hr light and 12 hr darkness


IN-LIFE DATES: NDA

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Amount / concentration applied:
0.5 ml of p-Bromoanisole
Duration of treatment / exposure:
Only 1 dose, the skin area was banded after application for 4 hours.
Observation period:
For Irritation- after removal of dressing-1, 24, 48, 72 hr. and 7, 14, 21 days.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: after 1 and 24 hr
Score:
2
Remarks on result:
other: The score is 2R, R=skin reaction extending approximately 4cm beyond treatment site.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: after 48 and 72 hr
Score:
1
Remarks on result:
other: The score is 1R, R=skin reaction extending approximately 4cm beyond treatment site.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: after 7 days
Remarks on result:
other: Adverse reactions prevent accurate evaluation of erythema. Crust formation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: after 14 days
Score:
0
Remarks on result:
other: The score is 0D, D=slight desquamation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: after 1, 24, 48 & 72 hr,
Score:
2
Remarks on result:
other: The score is 2R, R=skin reaction extending approximately 4cm beyond treatment site.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: after 7 days
Remarks on result:
other: Adverse reactions prevent accurate evaluation of erythema. Crust formation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: after 14 days
Score:
0
Remarks on result:
other: The score is 0D, D=slight desquamation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: after 1, 24, 48 & 72 hr
Score:
2
Remarks on result:
other: The score is 2R, R=skin reaction extending approximately 4cm beyond treatment site.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: after 7 days
Remarks on result:
other: Adverse reactions prevent accurate evaluation of erythema. Crust formation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: after 14 days
Score:
0
Remarks on result:
other: The score is 0D, D=slight desquamation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 1, 24 & 48 hr
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: after 72 hr, 7 & 14 days
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: after 1 & 24 hr
Score:
2
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: after 48 & 72 hr
Score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: after 7 & 14 days
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 1, 24 & 48 hr
Score:
2
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 72 hr
Score:
1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: after 7 & 14 days
Score:
0

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material p-Bromoanisol, produced a primary irritation index of 3.0 and was classified as a moderate irritatnt to rabbit skin according to the draize classification scheme. No corrosive effects were noted.
The test material produced positive criteria in 2/3 rabbits according to the EU labelling regulations and was classified as IRRITANT to rabbit skin. The symbole "Xi" and risk phrase R 38 "IRRITATING TO SKIN" are therefore required.