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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jun 1990 - Dec 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

Temperature higher than norm (23°C) noted each afternoon during the 3 days of the study: max. 27°C. Humidity lower than norm (30 %): min. 18 % R.H. These deviations were not considered to have affected the outcome or the objectives of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Version / remarks:

1985

Deviations:

no

GLP compliance:

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bancel, Albon, France
- Age at study initiation: adult
- Weight at study initiation: 2.45 - 2.55 kg
- Housing: single
- Diet: approx. 150 g per animal per day
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-27
- Humidity (%): 18-54
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12 (illumination: 7.30 am to 7.30 pm)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g (0.6 ml)
- Concentration: 0.5 g (i.e. 1.8693 g of purified water for 4 g of test article)

VEHICLE
- Concentration: 0.23 g purified water

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back or flank
- Coverage: approx. 6 cm²
- Type of wrap if used: 8-layer thick Codex hydrophilic gauze

REMOVAL OF TEST SUBSTANCE
- Washing: yes, surplus test article was removed using a gauze compress moistened with purified water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
- 1, 24, 48, 72 h

SCORING SYSTEM:
- Method of calculation: Calculation of the mean values for primary cutaneous irritation from the evaluation of the erythematous and oedematous lesions observed at 24, 48 and 72 hours (and possibly at Days 7 and l4) according to a given numerical scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Other effects:

- Other adverse systemic effects: no mortality, no changes in behavior, no clinical signs

Any other information on results incl. tables

Evaluation of irritation after removal of semi-occlusive patches

RABBITS N°		58143	58146	58147	58148	58153	58160	TOTAL	MEAN
	1 H	1	1	0	0	0	0	2	0.33
	24 H	0	0	0	0	0	0	0	0.00
	48 H	0	0	0	0	0	0	0	0.00
	72 H	0	0	0	0	0	0	0	0.00
					ERYTHEMA: MEAN 24 H + 48 H + 72 H				0.00

 

RABBITS N°		58143	58146	58147	58148	58153	58160	TOTAL	MEAN
	1 HOUR	0	0	0	0	0	0	0	0.00
	24 HOURS	0	0	0	0	0	0	0	0.00
	48 HOURS	0	0	0	0	0	0	0	0.00
	72 HOURS	0	0	0	0	0	0	0	0.00
					OEDEMA: MEAN 24 H+48 H+72H				0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the consitions of the study, the test substance did not cause skin irritation in rabbits and thus was concluded not to be an irritant.

Executive summary:

The test article was applied at the dose level of 0.5 g prepared as a paste with 0.23 g of purified water, per animal, under a semi-occlusive patch for 4 hours, to the intact skin of 6 New-Zealand hybrid albino male rabbits. The cutaneous examinations were performed, for erythema and oedema, according to a given numerical scale, 1, 24, 48 and 72 hours after removal of the patch. Mean values were calculated from the evaluation of the cutaneous lesions performed in all the rabbits examined at 24, 48 and 72 hours. Mean values for cutaneous irritation were as follows :

- at 24 hours : 0.00; 0.00 (erythema and oedema)

- at 48 hours : 0.00; 0.00 (erythema and oedema)

- at 72 hours : 0.00; 0.00 (erythema and oedema)

i.e. a global average (24 hours + 48 hours + 72 hours) of 0.00 for erythema and of 0.00 for oedema. In conclusion, from the results obtained under the experimental conditions, application of this test article to the rabbit' skin can be designated as non-irritant.