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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
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetraphenylphosphonium phenolate
EC Number:
239-480-3
EC Name:
Tetraphenylphosphonium phenolate
Cas Number:
15464-47-8
Molecular formula:
C24H20P.C6H5O
IUPAC Name:
tetraphenylphosphanium benzenolate
Constituent 2
Chemical structure
Reference substance name:
Phenol
EC Number:
203-632-7
EC Name:
Phenol
Cas Number:
108-95-2
Molecular formula:
C6H6O
IUPAC Name:
phenol
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CHR. Fred Leuschner & Co., 24601 Löhndorf/Post Warendorf, Germany
- Age at study initiation: 4-6 months
- Weight at study initiation: 2.3 - 2-4 kg
- Acclimation period: at least 20 days

IN-LIFE DATES: From: 1998-01-29 To: 1998-02-01

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
pasted with water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per patch
Duration of treatment / exposure:
4 hour(s)
Observation period:
Scores were taken 60 min, 24, 48, and 72 hours after patch removal. Skin reactions were monitored until the changes observed have completely subsided, however not for more than 14 days after application.
Number of animals:
3
Details on study design:
The fur was removed by shaving the dorsal area of the trunk of 3 rabbits 24 hours prior to use. Only animals with healthy skin were used.
A dose of 500 mg was applied to the test sits (pulverized test substance moistened with water) and then covered with a gauze patch held in place with a semi-occlusive dressing. After 4 hours, the patches were removed and each site was assessed; the severity of the reaction was recorded 60 min, 24, 48, and 72 hours after patch removal.

- Scoring system: score range 0 - 4 for erythema and eschar formation; score range 0-4 for oedema formation; if other lesions occur, they will be listed


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No redness or swelling was observed on the skin of any of the 3 rabbits 60 min, 24, 48, and 72 hours after exposure to the test material. Therefore, the primary irritation score was 0.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was classified as not irritating to rabbit's skin on the basis of the scores which were 0.0 out of a possible 4.
Executive summary:

In a skin irritation test performed according to OECD 404 none of the three rabbits exposed for 4 hours under semi-occulsive conditions to the test substance showed any skin reaction (score 0.0 for erythema and edema). Thus, the test substance is not irritating to the skin of rabbits.