2-imidazolidone

Endpoint summary

Description of key information

The substance is not irritating to skin of rabbits, but irritating to the eyes of rabbits.

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The substance was applied (90% in water) in the form of a paste for 1, 5, 15 minutes or 20 hours to the rabbit skin on the back.

GLP compliance:

no

Remarks:

pre-GLP

Species:

rabbit

Strain:

Vienna White

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

other: untreated skin of same animal

Amount / concentration applied:

90% in water in the form of a paste (amount not specified)

Duration of treatment / exposure:

1 minute, 5 minutes, 15 minutes and 20 hours

Observation period:

8 days

Number of animals:

5 in total; substance has been applied on the skin of the back of all 5 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: concentrated Lutrol and 50% lutrol
- Time after start of exposure: see duration of exposure; 1 minute, 5 minutes, 15 minutes and 20 hours

Irritation parameter:

edema score

Remarks:

(1, 5 and 15 minutes of exposure)

Basis:

mean

Time point:

other: 24 hours and 8 days

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

(1, 5 and 15 minutes of exposure)

Basis:

mean

Time point:

other: 24 hours and 8 days

Score:

0

Max. score:

4

Irritation parameter:

other: observations regarding skin irritation in case of 20 hours exposure

Basis:

mean

Remarks on result:

other: Slight erythema with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized); fallen off at 8 days.

Irritant / corrosive response data:

The application for 1, 5 or 15 minutes on the back led to no findings within 8 days. After application for 20 hours, on the back, slight erythema was recorded with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized; fallen off) were recorded at day 8 of the observation period.

Interpretation of results:

GHS criteria not met

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

The test substance was applied as powder (0.1 g) into the right eyes of 2 rabbits, the left eye was treated with physiological saline solution for comparison. The observation period was 10 days.

GLP compliance:

no

Remarks:

pre-GLP

Species:

rabbit

Strain:

Vienna White

Vehicle:

unchanged (no vehicle)

Controls:

other: saline-treated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

single application, no washing was performed

Observation period (in vivo):

10 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

Irritation parameter:

other: observations regarding eye irritation

Basis:

other: observations in individual animals

Remarks on result:

other: Findings: on day of treatment: redness and discharge in 2/2; day 2: redness in 1/2, discharge and slight opacity in 1/2; day 3: redness and chemosis in 1/2; day 6: complete reversibility

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (90% in water in the form of a paste) for 1, 5, 15 minutes or 20 hours to the rabbit skin on the back under occlusive conditions (BASF, VIII/56, 1958). The application for 1, 5 or 15 minutes on the back led to no findings within 8 days. After application for 20 hours, on the back, slight erythema was recorded with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized; fallen off) were recorded at day 8 of the observation period. Assessment according to current criteria considering 4-hours exposure led to the classification "not irritating".

Eye irritation 
In a non-GLP study according to a method comparable to OECD guideline 405, the test substance was applied as powder (0.1 g) into the right eyes of 2 rabbits, the left eye was treated with physiological saline solution for comparison (BASF, VIII/56, 1958). No washing was performed. On the day of treatment redness and discharge in 2 out of 2 animals were recorded, on day 2 redness, discharge and slight opacity were observed in 1 out of 2 animals and on day 3 redness and chemosis were recorded in 1 out of 2 animals. At day 6 complete reversibility was observed. Assessment according to current criteria led to the classification "irritating".
 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on eye  irritation/corrosion, the test item is considered to be classified as cat. 2, H319 ("causes serious eye irritation") according to Regulation (EC) No 1272/2008 (CLP).