1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

EC Number:

248-597-9

EC Name:

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Cas Number:

27676-62-6

Molecular formula:

C48H69N3O6

IUPAC Name:

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Details on test material:

- Physical state: solid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2080 t o 2310 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Swi tzerland (ad libitum)
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Controls:

other: untreated skin of same animal

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3 females

Details on study design:

An area of at least 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (20 cm2) bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80. The patches were loosely covered with aluminum foil held in place for by an adhesive tape. The animals were checked daily for systemic symptoms and mortality.

SCORING SYSTEM:
as described in OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item induced slight erythema reactions only at the 1h timepoint.

Any other information on results incl. tables

Individual skin reaction scores:

	Animal No.	1(f)	2(f)	3(f)
Erythema	1 h	1	1	1
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	mean 24-72 h	0	0	0
Edema	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	mean 24-72 h	0	0	0

Individual body weights (g):

Animal No.	1 (f)	2 (f)	3 (f)
at start of test	2095	2080	2310
after 3 days (end)	2170	2110	2380

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

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

Executive summary:

The primary skin irritation potential of the test substance was investigated according to OECD test guideline no. 404. The test item was applied by topical application of 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 after removal of the patches. The test item induced slight erythema reactions when applied to albino rabbit skin. The reactions were observed only one hour after removing the

bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test substance can be classified as non-irritant.