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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Due to the physical-chemical properties, the test substance had to be applied by weight.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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, white
- Analytical purity: > 95%
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: (Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: not specified
- Weight at study initiation: 207 to 273 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on dermal exposure:

TEST SITE
- Area of exposure: back of the rat
- % coverage: 10
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied (ml/kg body weight): 4 g (corresponding approximately to 4 ml).

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortalities

Clinical signs:

other: Piloerection and hunched posture were seen, the animals recovered within 2 days.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Any other information on results incl. tables

Animal number	Body weights (g) Day 0	Body weights (g) Day 7	Body weights (g) Day 14
MALES dosed with 2000 mg/kg bodyweight
1	264	307	350
2	273	301	333
3	256	290	319
4	265	291	317
5	260	288	316
mean	264	295	327
SD	6.3	8.2	14.6
FEMALES dosed with 2000 mg/kg bodyweight
1	254	253	291
2	232	241	252
3	229	247	240
4	207	212	235
5	221	226	235
mean	229	236	251
SD	17.2	16.7	23.6

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute dermal LD50 of the test substance in rats of both sexes is greater than 2000 mg/kg body weight.

Executive summary:

Five male and five female (Tif: RAI f (SPF)) rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was diluted in 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 and applied at a dosage of 2 g/kg. The application period was 24 hours. No deaths occurred during the study. Clinical signs were piloerection and hunched posture, being common symptoms in acute dermal tests. No macroscopic findings were observed at necropsy. In conclusion, the median lethal dose of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.