Disodium sebacate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Skin sensitisation in guinea pigs via intradermal injection of the test substnace for induction (seven doses) and challenge.

GLP compliance:

not specified

Remarks:

pre-GLP

Type of study:

intracutaneous test

Justification for non-LLNA method:

The LLNA was not established at that time.

Test material

Test material information

Constituent 1

Reference substance name:

Sebacic acid

EC Number:

203-845-5

EC Name:

Sebacic acid

Cas Number:

111-20-6

Molecular formula:

C10H18O4

IUPAC Name:

sebacic acid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Sweetwater Farms

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

peanut oil

Concentration / amount:

0.1%

Day(s)/duration:

15 days

Adequacy of induction:

other: 7 injections of the test substance evenly distributed over 15 days

Challenge

No.:

#1

Route:

intradermal

Vehicle:

peanut oil

Concentration / amount:

0.1 %

Day(s)/duration:

48 h

Adequacy of challenge:

other: injection of the test substance

No. of animals per dose:

20

Details on study design:

Twenty male albino guinea pigs were used to test the sensitizing potential of the materials. The sensitization test was started on a Monday when the guinea pigs were weighed and closely clipped on the scapular areas. The material (0.05 mL of a 0.1% dilution in peanut oil) was injected intradermally into the upper right scapular area of each pig. A similar injection of peanut oil alone into the upper left scapular area served as a control site. Readings were made 24 and 48 hours later. Doses of 0.1 mL of the same dilutions (freshly prepared) were injected into the clipped dorsal lumbo-sacral areas of the guinea pigs on the following Wednesday, Friday, Monday, etc., until seven doses were administered. Care was taken to insure that the repeated doses were not injected into the same site. The guinea pigs were rested for three weeks (incubation period), weighed and given a challenge dose of 0.05 mL of the 0.1% dilution of the test material into the lower right scapular area. A control injection of the vehicle alone was also administered into the lower left scapular area at this time. The reactions were read after 24 and 48 hours.

Results and discussion

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 %

No. with + reactions:

3

Total no. in group:

20

Remarks on result:

other: No. of sensitized animals were not given in the report. Highest number of sensitized animals in the corresponding category was chosen.

Any other information on results incl. tables

Sebacic acid caused a mild sensitization response (final grades per animal: 26 -99) and was categorized as a substance with "slight" sensitization potential. According to the applied scoring system, this refers to 1 - 3 animals out of 20 with mild reactions (final grade per animal > 26, according to the corresponding grading system).

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification