Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating (BASF SE, 1989)
Eye irritation (OECD 405): highly irritating (BASF SE, 1989)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented study report

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

The animal(s) were held in stainless steel cages (floor area 40 x 51 cm). Identification of the animal(s) via ear tattoo. The animals were housedin fully air-conditioned rooms with a temperature in the range of 20 - 24°C and a relative humidity of 30 - 70%. The light/dark rhythm was 12 h light and 12 h darkness. A standardized rabbit diet (about 130 g per day) and about 250 ml tap water were offered.
Acclimatization period: At least 8 days before the beginning of the study (with the same housing conditions as during the study).
Clipping of the fur: At least 15 hours before the start of the study.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

8 days (first test) or 72 hours (second and third test discontinued after 72 hours because no irritation could be observed at that time)

Number of animals:

6 (2 males, 4 females)

Details on study design:

Application site: upper third of the back or flank
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
readings: 30 - 60 min after removal of the test patches and 24, 48, 72 h and 8 d after the start of application.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.8

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a study based on OECD 404 performed under non-GLP conditions, no edema was observed in 6 animals after 4-h semiocclusive exposure. Transient erythema was recorded in single animals, which led to a mean score of 0.8. Thus, the test substance is not irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented study report

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

The animals were identified via ear tattoo. They were held (singly) in stainless steel cages (floor area: 40 x 51 cm). The animals were housed in fulfly aiar-conditioned rooms with a temperature ranging from 20 - 24°C and a relative humidity between 30 - 70%. The light/dark rhythm was 12 hours dark and 12 h ours light. A standard rabbit diet (about 130 g/animal/day) and about 250 ml tap water/animal/day were offered. The acclimatization period was at least 8 days before the beginning of the study (same housing conditions as during the study).

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

3

Details on study design:

Single application to the conjunctival sac of the right eyelid; the test substance was not washed out.
Readings were done 1 h, 24 h, 48 h, 72 h, 8 d, 15 d and 21 d after instillation.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 21 d

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0.8

Max. score:

1

Reversibility:

fully reversible within: 21 d

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

2.2

Max. score:

3

Reversibility:

not fully reversible within: 21 d

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

1.7

Max. score:

2

Reversibility:

not fully reversible within: 21 d

Interpretation of results:

highly irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

The test substance was analysed for its potential to induce skin irritation equivalent or similar to OECD guideline 404 under non-GLP conditions . Therefore, six Vienna white rabbits (4 females, 2 males) were treated for 4 hrs with 0.5 mL of the test item and animals observed for up to 8 days. The erythema score was calculated (based on the 24, 48 and 72 hrs time points) as 0.8 with lesions being fully reversible within 8 days; no edema was observed in 6 animals after 4-h semiocclusive exposure.

This results was consistent with a supporting study showing that the application of 0.5 mL of the test item for 3 min or 1 hr, respectively, did not induce edema and resulted in erythema that was fully reversible within 15 days. Thus, the test item is not irritating.

Eye irritation/corrosion:

The potential of the test substance to induce eye irritants was measured with the means of an in vivo test on rabbits (OECD 405) under non-GLP guidelines. A single dose of 0.1 mL of the liquid test item was introduced into the conjunctival sac of the left eye of 3 Vienna white rabbits (one male, two females). Eyes were closely analysed 1, 24, 48, 72 hrs, 8, 15 and 21 days following administration of the test substance. The following mean score were calculated: cornea score = 1, iris score= 0.8, conjunctivae score = 2.2 and chemosis score = 1.7. Besides the lesions of the iris, all other irritations were not fully reversible within the 21 day observation period.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the available data, the test substance is not classified with regard to skin irritation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.

According to the harmonised classification criteria laid down in Council Directive 67/548/EEC, Annex I (and subsequent adaptations) the test substance should be classified as highly irritating to the eyes and assigned the symbol Xi, the indication of danger "Irritant" and the risk phrase R41: "Risk of serious damage to eyes" applied.

According to Annex VI, Regulation (EC) No 1272/2008, the following harmonised classification and labelling is proposed: category 1, "Danger", H318 "causes serious eye damage".