p,p'-(2-pyridylmethylene)bisphenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-11-14 to 2002-11-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted under GLP conditions in accordance with the official OECD guideline No 404 (2002)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(April 2002)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(July 1992)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

p,p'-(2-pyridylmethylene)bisphenol

EC Number:

210-039-7

EC Name:

p,p'-(2-pyridylmethylene)bisphenol

Cas Number:

603-41-8

Molecular formula:

C18H15NO2

IUPAC Name:

4-[(4-hydroxyphenyl)(pyridin-2-yl)methyl]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: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France- Age at study initiation: 12 weeks (male), 12 - 13 weeks (females)- Weight at study initiation: 2102 g (male), 2056 to 2073 g (female)- Housing: Individually in stainless steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.ENVIRONMENTAL CONDITIONS- Temperature (°C): 17-23°C- Humidity (%): 30 to 70%- Air changes (per hr): 10 to 15 per hr- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g (per animal)VEHICLE- Amount(s) applied (volume or weight with unit): 0.1 ml of purified water

Duration of treatment / exposure:

4 hrs

Observation period:

1, 24, 48, 72 hrs

Number of animals:

3

Details on study design:

TEST SITE- Area of exposure: 4 cm * 4 cm, (flank)- Type of wrap if used: surgical gauze patch. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.REMOVAL OF TEST SUBSTANCE- Washing (if done): lukewarm tap water- Time after start of exposure: 4 hoursSCORING SYSTEM: according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Any other information on results incl. tables

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), Oxypicoline RF is considered to be 'not irritating' to rabbit skin.