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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1-bromo-4-methoxybenzene

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.