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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Type of information:

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

Adequacy of study:

supporting study

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

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

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.782 - 2.815 kg
No further information is provided on test animals and environmental conditions.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

2 (1 male and 1 female)

Details on study design:

TEST SITE
- Area of exposure: the backs of the rabbits were clipped with an electric clipper approximately 24 hours prior to test initiation.
- Test material administration: 0.5 mL of neat test material was applied to the test site and the animals bandaged for 4 hours o provide occlusion and prevent grooming of the application site.

SCORING
Four hours after application of the test material, the bandages were removed and the application sites were graded.

Results and discussion

In vivo

Irritant / corrosive response data:

One rabbit had slight erythema on the day of dosing. Both rabbits had slight erythema and oedema from test day 2 through to test day 4. On test day 7 both rabbits appeared normal.

Other effects:

There was no effect on the body weights of the rabbits (see Table 1).

Any other information on results incl. tables

Table 1: Individual Body Weights (kg)

Animal	Test day
	1	7
1	2.782	2.866
2	2.815	2.914

Applicant's summary and conclusion

Interpretation of results:

other: It is not possible to assign a classification for skin irritation potential with the available data.

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material elicited only a slight response in both of the test animals. However, it is not possible to assign a classification for skin irritation potential with the available data.

Executive summary:

The skin irritation potential of the test material was investigated in a study which was conducted to a methodology similar to that which is outlined in the standardised guideline OECD 404.

During the study, two New Zealand White rabbits were exposed to 0.5 mL of neat test material under an occluded wrap for four hours. Following the exposure period, the bandages were removed and the application sites were graded.

One rabbit had slight erythema on the day of dosing. Both rabbits had slight erythema and oedema from test day 2 through to test day 4. On test day 7 both rabbits appeared normal. There was no effect on the body weights of the rabbits.

Under the conditions of the study, the test material elicited only a slight response in both of the test animals. However, it is not possible to assign a classification for skin irritation potential with the available data.