1-isoctyloxycarbonyl ethylated 2,4,6 tris (2,4- hydroxyphenyl) -1,3,5 triazine derivatives

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline conform study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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: 11 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood (RCC Ltd, Fullinsdorf) and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 93/01) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis are archived at RCC Ltd, Itingen. Haysticks (QS no. 125/01) provided by Eberie Nafag AG, CH-9200 Gossau.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, aof libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES:
Experimental Starting Date 27-DEC-2001
Experimental Completion Date 16-JAN-2002
Delivery of the Animals 27-DEC-2001
Acclimatization 27-DEC-2001 to 01-JAN-2002
Treatment 02-JAN-2002
Observation Throughout 14 days after treatment.
Termination 16-JAN-2002
Study Completion Date 27-FEB-2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

The skin reaction was assessed 1, 24, 48 and 72 hours, as
well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: flank
- coverage: 100 cm2
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: 4h

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

ERYTHEMA AND ESCHAR FORMATION
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema)
reading 4

OEDEMA FORMATION
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure).... 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

3

Irritant / corrosive response data:

Slight erythema was observed in all animals 1 hour after treatment. The severity of the
erythema increased in all animals to moderate at the 24-hour reading but subsequently
cleared within 7 days of treatment.
No irreversible alterations of the treated skin were observed nor were corrosive effects
evident on the skin.

Other effects:

The application area was washed after removal of the dressing, however, the test item
strongly adhered to the test site and a residue was evident on the skin of all animals
throughout the 14 day observation period.
A light yellow staining was present at the test site of all animals throughout the 14 day
observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is considered to be "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of the test substance was investigated by topical semi-occlusive application of approximately 0.5 g to the 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 three animals was 1.33, 0.67 and 0.67, respectively and the mean oedema score was 0.00 for all animals. The application to the rabbit skin resulted in mild, eariy-onset and transient signs of irritation. Erythema was observed in all animals during the observation period but diminished to clear within 7 days of treatment. The application area was washed after removal of the dressing but a residue of the test item strongly adhered to the test site and was evident on the skin of all animals throughout the 14 day observation period. A light yellow staining was also present at the test site of all animals throughout the observation period. No corrosive effects were noted on the treated skin of any animal at any measuring interval.