Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline equivalent study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: lquid
Details on test material:
Purity 99.0%
Impurities present:
3,3,3,4,4-pentafluoro-1-butene = 0.87%
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octene = 0.08%
1,1,1,2,2,3,3,4,4-nonafluoro-4-iodobutane = 0.004%

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hrs
Observation period:
48 hrs
Number of animals:
6
Details on study design:
Six male albino rabbits were clipped free of hair on the trunk and lateral area and placed in FDA-type stocks. Doses of 0.5 ml of undiluted test material were applied to intact skin under 1 ½ inch x 1 ½ inch 12-ply gauze squares. Rubber sheeting was then loosely wrapped around the trunk and secured with adhesive tape. After 24 hours, the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Table 1: Results of PFBE Skin Irritation Test in Rabbits.

24-Hour Observation

48-Hour Observation

Erythema

Oedema

Erythema

Oedema

None 6/6

None 6/6

None 6/6

None 6/6

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused no skin irritation in 24 or 48 hrs when tested on the shaved intact skin of 6 male rabbits.
Executive summary:

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused no skin irritation in 24 or 48 hrs when tested on the shaved intact skin of 6 male rabbits.