Pyrimidine, 2-ethoxy-4,6-difluoro-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

Not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in accordance with generally accepted scientific principles; however full data on methodology is not given and no information relating to GLP status is provided. Furthermore, sufficient information on substance identity is not provided. An accurate assessment of the study is therefore not considered to be possible.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): 2-ethoxy-4,6-difluoropyrimidine (DFEP) tar bottoms
- Appearance: dark brown, viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.766 - 2.793 kg
No further information is provided on test animals and environmental conditions.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Preparation of test site: rabbits had their trunk clipped 24 hours prior to dosing
- Type of wrap if used: the applied test material was covered with an occluded wrap which, in turn, was covered by an elastic rabbit jacket

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

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: animals were weighed on test days 1, 2, 8 and 15
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs and dermal irritation

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Both animals survived the test period.

Clinical signs:

other: No clinical signs of systemic toxicity were observed.

Other findings:

Both rabbits had erythema and oedema from test day 2 through test day 8. Scaling was noted on both rabbits from test day 8 through to study termination.

Any other information on results incl. tables

Table 1: Individual Body Weights (kg)

Animal	Test day
	1	2	8	15
1	2.766	2.954	3.119	3.259
2	2.793	2.868	2.805	2.923

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 the study, the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg.

Executive summary:

The acute dermal toxicity of the test material was investigated in a study which was conducted to a method similar to that which is outlined in standardised guideline OECD 402.

During the study, 2000 mg/kg of neat test material was applied to the clipped trunks of 2 male New Zealand White rabbits under an occluded wrap which, in turn was covered with an elastic rabbit jacket. Residual test material was wiped off when the bandage was removed 24 hours after application. Both animals survived and both gained weight during the study. No clinical signs of systemic toxicity were observed. Both rabbits had erythema and oedema from test day 2 through test day 8. Scaling was noted on both rabbits from test day 8 through to study termination.

Under the conditions of the study, the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg. As such, the test material requires no classification in accordance with EU criteria.