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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
The information was generated in 1978. Invitro/ ex-vivo tests were not available.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act Regulations, Federal Register vol. 33, section 1500.41
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A supplier local to the testing laboratory
- Age at study initiation: NDA
- Weight at study initiation: 2 - 3 kg
- Housing: NDA
- Diet (e.g. ad libitum): NDA
- Water (e.g. ad libitum): NDA
- Acclimation period: At least 3 weeks in laboratory conditions.


ENVIRONMENTAL CONDITIONS
NDA


IN-LIFE DATES: NDA

Test system

Type of coverage:
occlusive
Preparation of test site:
other: 3 animals with a clipped patch, 3 with an abraded patch
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): N/A


VEHICLE
No vehicle used
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 rabbits of unspecified sex.
Details on study design:
TEST SITE
- Area of exposure: less than one square inch.
- % coverage: NDA
- Type of wrap if used: one square inch sugical gauze. The trunk of the animal was wrapped in an impervious material in place for 24 hours.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing stated.
- Time after start of exposure: N/A


SCORING SYSTEM: Erythema, edema and primary irritation score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.17
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Edema only observed for one animal with abraded skin. No effects seen on animals with clipped skin.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.33
Max. score:
2
Reversibility:
no data
Remarks on result:
other: Edema only observed for one animal with abraded skin. No effects seen on animals with clipped skin.

Any other information on results incl. tables

Primary irritation score = 0.25

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Edema was observed in one out of the six animals tested. No eschar formation was observed. Propylbromide is considered to be a nonirritant.
Executive summary:

An acute dermal irritation study was performed on 1-bromopropane using 6 albino rabbits with weights from 2 - 3 kg (24 hour exposure, tests sites both intact and abraded) representing a worst case scenario for assessing irritation.

Edema was observed in one out of the six animals tested. No eschar formation was observed. Propylbromide is considered as a nonirritant.