N,N''-(isobutylidene)diurea

Endpoint summary

Description of key information

A skin and an eye irritation study is available (BASF AG, 1967) which addresses both endpoints adequately.

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: limited documentation, substance tested only as 50% dilution, observation/reading only at 24 hours and 8 days, only 2 animals tested

Principles of method if other than guideline:

The test substance was applied as 50% dilution for 20 hours under occlusive conditions. Observation/reading only at 24 hours and 8 days, only 2 animals tested

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: ca. 2.8 kg
- sex: male

no further data

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

Substance applied as a 50 % aqueous preparation (ca. 0.5 g on an area of about 2 .5 cm x 2.5 cm); occlusive application

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 24 hours and 8 days were selected as reading time points

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 24 hours and 8 days were selected as reading time points

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 24 hours and 8 days were selected as reading time points

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 24 hours and 8 days were selected as reading time points

- Systemic toxicity: No mortality occurred. There were no signs of clinical toxicity from the dermal exposure.

- Irritation score: No skin findings were observed at any time 

- Summary: Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation.

Interpretation of results:

GHS criteria not met

Conclusions:

Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.

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: limited documentation, only 2 animals tested, only 50 µl applicated

Principles of method if other than guideline:

The test substance was applied as a single instillation (50 µl) as powder, the substance was not washed out, only 2 rabbits were used

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

no further data

Vehicle:

unchanged (no vehicle)

Controls:

other: treated with talcum powder

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 microliter (50 mm3)

Duration of treatment / exposure:

single instillation of the test substance as powder, the substance was not washed out

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: none, substance not washed out

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Summary:

The treatment led to slight redness. All findings were reversible after 8 days of observation period. The control eyes which were treated with talcum powder did show the same reactions.

Interpretation of results:

GHS criteria not met

Conclusions:

The mean score observed for redness of the conjunctivae is 0.167 ( for 24, 48 and 72 hours) which is below 2.5.
These finding were reversible within 48 hours.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In an older skin irritation study with 2 rabbits performed with ca. 0.5 g of a 50 % aqueous suspension of IBDU (purity ca. 90 - 96 %) under occlusive conditions for 20 hours, no local effects or other clinical signs were observed (reading time points: 24 hours and 8 days after application) (BASF AG, 1967).

 

Eye irritation

In an older eye irritation study with 2 rabbits performed with ca. 0.05 ml IBDU (purity ca. 90 -96%), slight redness (grade 1) was observed 24 hours after application in both animals. These findings were fully reversible within 48 hours (BASF AG, 1967).

 

Respiratory Tract

This information is not available  

Justification for classification or non-classification

No classification and labeling is required, as no skin irritation was observed and eye irritation was marginal as only slight redness was observed after 24 hours, which was fully reversible after 48 hours.