1,3,5-Triazine-2,4-diamine, N2,N2,N4,N4-tetrabutyl-6-chloro-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jul 1990 - Feb 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Version / remarks:

1985

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Terbuthylazine

EC Number:

227-637-9

EC Name:

Terbuthylazine

Cas Number:

5915-41-3

Molecular formula:

C9H16ClN5

IUPAC Name:

N-tert-butyl-6-chloro-N'-ethyl-1,3,5-triazine-2,4-diamine

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

other: OFA.SD. (IOPS Caw.)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Crédo, France
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 209-245 g
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 34-90
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of the total body surface
- % coverage: 100
- Type of wrap: perforated adhesive band (Peloplast) 10 cm wide, applied onto an elastic crepe bandage (Creplux / Molinier)

REMOVAL OF TEST SUBSTANCE
- Washing: yes, using lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied (volume or weight with unit): 76.46% (w/v) in the vehicle
- For solids, paste formed: yes
- Preparation: performed 1.5 h at meximum before administration

Duration of exposure:

24 h

Doses:

2000 mg/kg equivalent to 2616 ml/kg of the test article as paste at 76.46% (w/v) in purified water.

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 and weighing: 15 min, 1, 2, and 4 h and then daily after application. Body weight at days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

No mortality was observed in the preliminary study at 1000 and 2000 mg/kg in males and females.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: There were no changes in behaviour or clinical signs in any of the treated animals during the observation period. The local tolerance of the test article was good : no cutaneous lesion (erythema or oedema) was noted to the application site of the test art

Gross pathology:

There were no macroscopic 'findings that could be associated with treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

From the results obtained under the experimental conditions employed, the LD0 by the cutaneous route in the rat, of the test article prepared as a paste at 76,46 % (W/V) and administered once only, as supplied, is greater than of equal to 2000 mg/kg for males and females combined, and for males and females separately. There were no effect of treatment in any of the parameters examined.

Executive summary:

The test article was prepared as a paste at 76.46 % (W/V) in purified water and applied at the dose level of 2000 mg/kg, by the cutaneous route, in the Sprague-Dawley rat (5 males + 5 females). Mortality and abnormal clinical signs were noted 15 minutes after application, then at 1, 2 and 4 hours, and then daily for the l4 day study period. All the animals were weighed immediately before application of the test article (Day 1), on Days 8 and 15. A necropsy was performed for all the animals after the l4 day study period and the final observation (Day 15). No mortality nor any pathological clinical sign was noted. In conclusion, from the results obtained under the experimental conditions employed, the LD 0 (theoretical dose level which should not kill any animal during a study performed under identical conditions on a large population) for males and females combined and for males and females separately, may be expressed as follows: LD 0, by the cutaneous route, in the rat > 2000 mg/kg.