Diethyl sebacate

Endpoint summary

Description of key information

For that endpoint, two reliable studies were performed on the registered substance, assessing skin and eye irritation.

In the skin irritation study, the aim was to assess the local cutaneous tolerance of the "DIETHYL SEBACATE Batch 1727003" in vivo, in 13 volunteers. Tolerance was studied after a patch test carried out under occlusive conditions and lasting 48 hours. Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be irritant nor corrosive for the skin (score=0).

In the eye irritation study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "Diethyl sebacate batch 021006" is considered not to be cytotoxic.

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

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:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

no guideline followed

Guideline:

other: In vivo test on Human : patch-tests simples 48h

GLP compliance:

no

Remarks:

In vivo study (patch-tests simples 48h)

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: empty cup

Amount / concentration applied:

pure

Duration of treatment / exposure:

48 hours

Observation period:

24 hours after the patch is removed

Number of animals:

test on human

Details on study design:

13 volunteers came to the EUROSAFE premises on the day the test started. They were identified by a 3-letter, 2-digit code. The test product was placed in the corresponding cup. The epidermal tests were then applied to the scapular area of the volunteers' backs. An empty cup was then used as a test control. Forty-eight hours after the application of the epidermal tests, they were delicately removed by the dermatologist and their location delimited with a skin pencil. Any skin reactions were read 30 minutes after the removal of the skin tests. A second reading by the dermatologist was carried out 24 hours after the first reading if a reaction was observed.

Irritation parameter:

overall irritation score

Basis:

other:

Time point:

48 h

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

the product caused no skin reactions in the 13 volunteers. In this study, with the limitations associated with the protocol (i.e. the inclusion of the limited number of 13 volunteers), the product, in pure mode, was shown to be non-irritating.

Executive summary:

For that endpoint, one reliable study on the registered substance was performed.

In this study, the aim was to assess the local cutaneous tolerance of the "DIETHYL SEBACATE Batch 1727003" in vivo, in 13 volunteers. Tolerance was studied after a patch test carried out under occlusive conditions and lasting 48 hours.

Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be irritant nor corrosive for the skin (score=0).

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

no guideline followed

Guideline:

other: National decree 5 April 1971 on official methods of analysis for cosmetics and beauty products

Principles of method if other than guideline:

official method for the evaluation of the irritant potential by direct application of rabbit corneal fibroblasts on monolayers by the neutral red release method

GLP compliance:

not specified

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

10% - 25% - 50% - 100%

Duration of treatment / exposure:

60 secondes

Duration of post- treatment incubation (in vitro):

Not specified

Number of animals or in vitro replicates:

Not specified

Irritation parameter:

other: percentage of mortality

Value:

0

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be cytotoxic.

Executive summary:

For that endpoint, one reliable study on the registered substance was performed.

In this study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "Diethyl sebacate batch 021006" is considered not to be cytotoxic.

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)