Reaction product of phosphorus trichloride with reaction mass of 4-tert-butylphenol and phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26-JUN-2001 - 18-JUL-2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-di-tert-butylphenyl diphenyl phosphite; 2-tert-butylphenyl diphenyl phosphite; 4-tert-butylphenyl diphenyl phosphite; triphenyl phosphite

EC Number:

941-802-9

Molecular formula:

Unspecified

IUPAC Name:

2,4-di-tert-butylphenyl diphenyl phosphite; 2-tert-butylphenyl diphenyl phosphite; 4-tert-butylphenyl diphenyl phosphite; triphenyl phosphite

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10-11 weeks (male), 10-12 weeks (females)

ENVIRONMENTAL CONDITIONS
details on husbandry are missing in the report

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 (1 male, 2 females)

Details on study design:

TEST SITE
- Area of exposure: flank
- Type of wrap if used: gauze patch, covered with semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Very slight to well-defined erythema was observed in two animals from 1 hour to 10 days after treatment and in the other animal from 1 hour to 7 days after treatment. Very slight to slight swelling was present in two animals from the 1- to 72-hour reading and in the other animal at both the 1- and 24-hour readings.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Applicant's summary and conclusion

Conclusions:

Based on the results of this study, the test item requires classification with R38 according to Dangerous Substance Directive (67/548/EEC).

Executive summary:

The primary skin irritation potential of the test article was investigated by topical semi-occlusive application of 0.5 ml to 6 cm² intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the the three animals was 2.00, 2.00 and 2.00, respectively and the mean oedema score was 2.00, 0.33 and 1.67, respectively. Very slight to well-defined erythema was observed in two animals from 1 hour to 10 days after treatment and in the other animal from 1 hour to 7 days after treatment. Swelling was also noted at the test site of all animals during the observation period. Very slight to slight swelling was present in two animals from the 1 - to 72-hour reading and in the other animal at both the 1 - and 24-hour readings. Scaling was evident at the test site of all animals on day 7 and persisted in two animals up to termination on day 14. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval.