Isodecyl 3,5,5-trimethylhexanoate

Endpoint summary

Description of key information

The key studies were conducted to recognised national testing guidelines.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 May 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Qualifier:

according to guideline

Guideline:

other: CFR 16, Part 1500.41

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL per patch, 4 patches on each of 6 rabbits

Duration of treatment / exposure:

24 and 72 hours

Observation period:

24 and 72 hours

Number of animals:

6

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0.5

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Interpretation of results:

GHS criteria not met

Conclusions:

The test material failed to induce sufficient dermal irritation to be considered irritating to skin.

Executive summary:

In this guideline (CFR 1500.41) study, the test material (unchanged) was administered topically to the intact skin of 6 rabbits. Results were measured at 24 and 72 hours using the draize scale. The test material failed to induce sufficient dermal irritation to be considered a dermal irritant.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 March 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Qualifier:

according to guideline

Guideline:

other: CFR 16, Part 1500.41

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: 10% dilution in corn oil

Controls:

not specified

Amount / concentration applied:

0.5 mL per patch, 2 patches on each of 6 rabbits

Duration of treatment / exposure:

24 and 72 hours

Observation period:

24 and 72 hours

Number of animals:

6

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

The test material failed to induce sufficient dermal irritation to be considered irritating to skin.

Executive summary:

In this guideline (CFR 1500.41) study, the test material (unchanged) was administered topically to the intact skin of 6 rabbits. Results were measured at 24 and 72 hours using the draize scale. The test material failed to induce sufficient dermal irritation to be considered a dermal irritant.

Reference 3

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 May 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1mL to one eye

Duration of treatment / exposure:

Eyes remained unwashed for 24 hours

Observation period (in vivo):

24, 48, 72 hours, 4 and 7 days

Number of animals or in vitro replicates:

6

Details on study design:

All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

0

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Mild (mostly 1 out of 5) conjunctiva were seen in most (5 out of 6) animals at 24 hours only, this has dissapeared at subsequent time points. No adverse observations were recorded with the cornea or iris at any time point.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material failed to induce sufficient eye irritation to be considered irritating to skin.

Executive summary:

In this guideline (CFR 1500.42) study, 0.1mL of the test item (no vehicle) was applied to one eye of 6 rabbits and remained unwashed for 24 hours.

Mild (mostly 1 out of 5) conjunctiva were seen in most (5 out of 6) animals at 24 hours only, this has dissapeared at subsequent time points. No adverse observations were recorded with the cornea or iris at any time point.

The test material failed to induce sufficient eye irritation to be considered irritating to skin.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 March 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Lot #3521

Species:

rabbit

Strain:

New Zealand White

Vehicle:

other: 10% Corn Oil

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1mL to one eye

Duration of treatment / exposure:

Eyes remained unwashed for 24 hours

Observation period (in vivo):

24, 48, 72 hours, 4 and 7 days

Number of animals or in vitro replicates:

6

Details on study design:

All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Draize Scores

group	24 hours	48 hours	72 hours	4 days	7 days
Unwashed	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

not irritating

Executive summary:

The test item (0.1mL in 10% corn oil) was applied to one eye of each of 6 rabbits.All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded. No adverse effects were recorded accoring to the Draize system. The test item was not irritating to the eye under these conditions.

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

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

The registered substance did not meet the criteria for consideration as an irritant to the skin or the eye in accordance with the Classification, Labelling, and Packaging (CLP) regulation.