Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 May 1990 - 11 June 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Internal, similar to OECD 404
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromoheptadecafluorooctane
EC Number:
207-028-4
EC Name:
1-bromoheptadecafluorooctane
Cas Number:
423-55-2
Molecular formula:
C8BrF17
IUPAC Name:
1-bromo-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane
Test material form:
liquid
Specific details on test material used for the study:
Physical state/Appearance: Clear colourless liquidStorage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Age of aniamls at study initiation: AdultWeight at study initiation: 2.0 -3.5 kgAcclimation period: At least 7 days Environmental controls for the animal room was set to maintain a temperature of 70 deg F ±3 deg F, a relative humidity of 50% ±20%, and a 12-hour light/12-hour dark cycle.

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,5 mL
Duration of treatment / exposure:
24 h exposure
Observation period:
72 h
Number of animals:
3 male and 3 female
Details on study design:
Test material was applied to two shaved test sites on each animal. Just before the test material was applied, crisscross epidermal abrasion were made on one of the exposed areas on each rabbit. The abrasions penetrated stratum corneum but they were not deep enough to penetrate the dermal layer and cause bleeding. Each treated area was covered with a gauze patch for 24 hours. The test site was washed with water after the 24h exposure period. Erythema and oedema was scored according to the Draize technique 30 minutes after the removal of the test material (24h). This was followed by a second reading after 72h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
0
Irritant / corrosive response data:
No signs of skin irritation were noted in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary dermal irritation of Imagent GI (PFOB) to the skin of rabbits was evaluated. The material produced no erythema or edema reactions. The primary dermal irritation index (the sum of the 24- and 72-hour scores divided by two) was determined to be 0.0, meaning that the material is not a primary skin irritant when tested by this method.