β-methyl-3-(1-methylethyl)benzenepropanal

Endpoint summary

Description of key information

Not skin irritant (OECD 404, GLP, 1988)

Not eye irritant (OECD 405, GLP, 1990)

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

Study period:

1988

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Batch No. 8906-87

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5mL undiluted

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

The hair was clipped from the dorsal area of the trunk of each rabbit approx. 24 hoursbefore treatment. Care was taken to avoid abrading the skin.
The test material (0.5mL) was applied to the intact skin on each rabbit under a 2.5cm x 2.5 cm patch gauze. The patch was then covered with micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 hrs. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or integrity of the epidermis.
Skin reactions were assessed 1, 24, 48 and 72hrs after patch removal.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72h

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight to well defined erythema was noted 1 hour to 48 hours after 4-hr semi-occluded exposure to the test item. No oedema was noted.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the individual scoring results, Florhydral does not need classification with regards to skin irritation.

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

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Batch number 8906-87
Purity 95.4%

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

instillation

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Details on study design:

On test day 1, 0.1ml of the pure test item was instilled once into the conjunctival sac of the left eye of each animal (2 Males and 1 Female) after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. Ther right eye remained iuntreated and served as the reference control.
The eyes of each animal were examined at 1, 24, 48 and 72hrs after administration. No recovery period was used.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

After 1 hour, only slight erythema, slight discharge and vessels visible in the sclera were observed. They all returned to normal from 24hrs on.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on this experimental result we can conclude that the test material is non-irritation for the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the test results available, the substance does not need any classification under CLP for skin or eye irritation.