Reaction mass of phenol and tetraphenylphosphonium phenolate

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

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.