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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

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:

0.1 g of test material was administered into each conjunctival sac of a New Zealand White rabbit. One eye was washed after 30 seconds while the remaining eye was washed after one hour. The animal was observed for 7 days.

GLP compliance:

not specified

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 4.10 kg on day 1 of the study

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test material per eye.

Duration of treatment / exposure:

One eye was exposed for 30 seconds while the remaining eye was exposed for one hour.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

One female

Details on study design:

ADMINISTRATION OF TEST SUBSTANCE
Ophthaine anaesthetic was administered to both eyes when the animal exhibited discomfort upon instillation of the test material into the first eye.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, washed with water.
- Time after start of exposure: One eye was washed after a 30-second exposure while the other eye was washed after a one hour exposure.

Results and discussion

In vivo

Irritant / corrosive response data:

Slight conjunctival redness and swelling was observed immediately after dosing in the 30-second exposure eye. The hour exposure eye could not be observed due to the physical properties of the test material. One hour after dosing, both eyes had a slight conjunctival response, and both had very slight conjunctival response at 24 hours after dosing. The 30-second exposure eye was observed with very slight conjunctival response 48 and 72 hours after dosing.
Irritation in both eyes was resolved by test day seven and the test was terminated seven days after instillation.

Other effects:

The animal survived the test period. No clinical signs indicative of systemic toxicity were observed. Bodyweight data are summarised in Table 1.

Any other information on results incl. tables

Table 1 Summary of Bodyweight Data (kg)

Animal Number	Test Day
	1	4
93A5474	4.10	4.00

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Both eyes had a very slight conjunctival response at 24 hours after dosing. The 30-second exposure eye was observed with very slight conjunctival response 48 and 72 hours after dosing. Irritation in both eyes was resolved by test day seven.
Although the report does not include scoring of the effects observed there is sufficient information to conclude that classification of the substance as an eye irritant is not required.

Executive summary:

The potential of the test material to cause ocular irritation was investigated in the New Zealand White rabbit.

0.1 g of the test material was administered into each conjunctival sac of a female rabbit. One eye was washed after 30 seconds while the remaining eye was washed after one hour. The animal was observed for 7 days.

Slight conjunctival redness and swelling was observed immediately after dosing in the 30-second exposure eye. The hour exposure eye could not be observed due to the physical properties of the test material. One hour after dosing, both eyes had a slight conjunctival response, and both had very slight conjunctival response at 24 hours after dosing. The 30-second exposure eye was observed with very slight conjunctival response 48 and 72 hours after dosing.

Irritation in both eyes was resolved by test day seven and the test was terminated seven days after instillation. No clinical signs indicative of systemic toxicity were observed.

Although the report does not include scoring of the effects observed there is sufficient information to conclude that classification of the substance as an eye irritant is not required.