[1,2,4]Triazolo[1,5-c]pyrimidine, 2,2'-dithiobis[5-ethoxy-7-fluoro-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles but with incomplete reporting. It is considered adequate for classification and labelling purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was administered as a single limit dose applied to the skin of two New Zealand White rabbits. Animals were observed for two weeks post-exposure.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-ethoxy-2-({5-ethoxy-7-fluoro-[1,2,4]triazolo[1,5-c]pyrimidin-2-yl}disulfanyl)-7-fluoro-[1,2,4]triazolo[1,5-c]pyrimidine

EC Number:

695-187-4

Cas Number:

166524-75-0

Molecular formula:

C14H12F2N8O2S2

IUPAC Name:

5-ethoxy-2-({5-ethoxy-7-fluoro-[1,2,4]triazolo[1,5-c]pyrimidin-2-yl}disulfanyl)-7-fluoro-[1,2,4]triazolo[1,5-c]pyrimidine

Details on test material:

- Name of test material (as cited in study report): 2,2'-Dithiobis(5-ethoxy-7-fluoro[1,2,4]triazolo[1,5-c]pyrimidine)
- Synonym: DEDS
- Appearance: light beige solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Average weight of 4.18 kg on day 1 of the study

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Trunk. Animals were prepared 24 hours prior to dosing by clipping the trunk.
- Type of wrap if used: An impervious, occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was wiped off when the bandage was removed.
- Time after start of exposure: 24 hours after application.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: Yes. 12 mL of distilled water were used to moisten the test material to ensure sufficient contact of the test material with the skin.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs and bodyweight. Bodyweights were reported on days 1, 2, 8 and 15.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs indicative of systemic toxicity were observed in the animals.

Any other information on results incl. tables

Table 1 Summary of Bodyweight Data (kg)

Animal Number	Test Day
	1	2	8	15
93A6263	4.36	4.32	4.35	4.38
93A4617	4.00	4.00	3.86	4.18

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the estimated acute dermal LD50 for female New Zealand White rabbits was greater than 2000 mg/kg. As such, the test material requires no classification in accordance with EU criteria.

Executive summary:

The acute dermal toxicity of the test material was investigated in New Zealand White rabbits.

A single application of 2000 mg/kg of the test material was applied to the clipped trunks of two female New Zealand White rabbits under an impervious, occlusive bandage. Distilled water was used to moisten the test material to ensure sufficient contact with the skin. The animals were exposed for 24 hours, followed by a post-exposure observation period of two weeks.

No mortality was observed and no clinical signs indicative of systemic toxicity were seen. Administration of the test material had no effect on body weight during the two week observation period.

Under the conditions of this study, the estimated acute dermal LD50 for female New Zealand White rabbits was greater than 2000 mg/kg. As such, the test material requires no classification in accordance with EU criteria.