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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, 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
Guideline:
other: The Consumer Product Safety Commission, Federal Register vol. 38, No. 187, 1500.42
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromopropane
EC Number:
203-445-0
EC Name:
1-bromopropane
Cas Number:
106-94-5
Molecular formula:
CH3CH2CH2Br
IUPAC Name:
1-bromopropane

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: NDA
- Age at study initiation: NDA
- Weight at study initiation: At least 2 kg
- Housing: The animals were housed singly and free of extraneous material which might cause irritation
- Diet (e.g. ad libitum): NDA
- Water (e.g. ad libitum): NDA
- Acclimation period: NDA
- Other: The animals were all in good health and free of eye defects and irritation.


ENVIRONMENTAL CONDITIONS
NDA


IN-LIFE DATES: NDA

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye served as negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL test material
- Concentration (if solution): N/A


VEHICLE
No vehicle used.


NEGTIVE CONTROL MATERIAL:
0.1 mL saline solution.
Duration of treatment / exposure:
The lids were gently held together for 10 seconds before releasing the rabbit. The eyes were not washed following treatment.
Observation period (in vivo):
The eyes were examined and grade of ocular reaction recorded at 24, 48, 72 hrs and 7 days with the aid of a hand ophthalmoscope. After 72 hrs and 7 days observation, the eyes were further examined, after applying fluorescein solution 2% in saline, to observe any corneal lesions, and the degree of irritation recorded.
Number of animals or in vitro replicates:
6 male albino rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
- Time after start of exposure: N/A


SCORING SYSTEM:
Grading of eye irritation was according to the scale of Draize and the Illustrated Guide for Grading Eye Irritation published by the F.D.A.
Scoring method was that of the Consumer Product Safety Commission, Federal Register vol. 38, No. 187, 1500.42


TOOL USED TO ASSESS SCORE: hand ophthalmoscope and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.21
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: First run
Irritation parameter:
other: Cornea area
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.21
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: First run
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.12
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days
Remarks on result:
other: First run
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: First run
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.88
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: First run
Irritation parameter:
other: Conjuctiva discharge
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.96
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: First run
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.04
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Second run
Irritation parameter:
other: Cornea area
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.04
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Second run
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.08
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Second run
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.83
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Second run
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.54
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Second run
Irritation parameter:
other: Conjunctive discharge
Basis:
mean
Time point:
other: mean of 24h, 48h, 72h and 7days
Score:
0.58
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Second run
Irritant / corrosive response data:
Since two out of the six animals tested exhibited a positive reaction (204, 206), the test was repeated using a group of six different rabbits. The second test was considered positive since three animals out of six tested exhibited positive reactions. Propylbromide is considered an eye irritant.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Two out of the six animals tested exhibited a positive reaction. Because of this, the test was repeated using a group of six different rabbits. The second test was considered positive since three animals out of six tested exhibited positive reactions. Propylbromide is considered an eye irritant.
Executive summary:

An acute eye irritation study was performed on 6 male rabbits weighing at least 2 kg. Grading of eye irritation was according to the scale of Draize and the Illustrated Guide for Grading Eye Irritation published by the F.D.A. Scoring method was that of the Consumer Product Safety Commission, Federal Register vol. 38, No. 187, 1500.42

Since two out of the six animals tested exhibited a positive reaction, the test was repeated using a group of six different rabbits. The second test was considered positive since three animals out of six tested exhibited positive reactions. Propylbromide is considered an eye irritant.