Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-09-12 to 1994-10-20

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Justification for type of information:

Justification for the read-across from the introduced read-across supporting substance (CAS 67938 -21 -0) to the registration substance:
The introduced read-across supporting substance (CAS 67938-21-0) is structurally related to the registration substance. Both substances are fatty acid esters of polyglycerols, the only diffence being that the introduced read-across source substance (CAS 67938-21-0) is synthesized by using isostearic acid as fatty acid while the registration substance by using stearic acid.
Both substances are expected to undergo enzymatic hydrolysis resulting into the release of polyglyerols and the corresponding fatty acids (isostearic acid for the read-across supporting substance and the stearic acid for the registration substance. Isostearic acid as well as the stearic acid are well-investigated substances and occurs also endogenously. No difference in the skin sensitization property can be reliably derived.

Reason / purpose for cross-reference:

assessment report

Interpretation of results:

GHS criteria not met

Executive summary:

No classification is warranted for the registration substance based on the read-across data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

The study was performed in 1994. No LLNA was available at that time.

Test material

Test material information

Constituent 1

Reference substance name:

Diglyceryl-diisostearate

IUPAC Name:

Diglyceryl-diisostearate

Constituent 2

Reference substance name:

Di(isooctadecanoic) acid, diester with oxydi(propanediol)

EC Number:

267-821-6

EC Name:

Di(isooctadecanoic) acid, diester with oxydi(propanediol)

Cas Number:

67938-21-0

Molecular formula:

C42H82O7

IUPAC Name:

di(isooctadecanoic) acid, diester with oxydi(propanediol)

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Hostacerin DGI; Synonym: Fettsaeurepolyglycerinester
- Physical state: Liquid, light yellow
- Lot/batch No.: E06 213955
- Expiration date of the lot/batch: End of August 1996
- Storage condition of test material: in the dark at room temperature

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright-White

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: Ethanol : Water (80 : 20)

Induction 2

Concentration / amount:

Pretest:
100 % undiluted test substance, 20 % (w/v) test substance diluted in Ethanol : Water (80 : 20); 4,0 % (w/v) test substance diluted in Ethanol : Water (80 : 20)
Induction:
100% undiluted test substance
Challenge:
20 % (w/v) test substance diluted in acetone

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: Ethanol : Water (80 : 20)

Challenge 2

Concentration / amount:

Pretest:
100 % undiluted test substance, 20 % (w/v) test substance diluted in Ethanol : Water (80 : 20); 4,0 % (w/v) test substance diluted in Ethanol : Water (80 : 20)
Induction:
100% undiluted test substance
Challenge:
20 % (w/v) test substance diluted in acetone

No. of animals per dose:

Pretest: 2 animals/dose concentration (i. e. 6 animals total)
Control group: 10 animals
Treatment group: 20 animals

Challenge controls:

The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100 % undiluted

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 % undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.

Executive summary:

In order to test for possible skin sensitizing effects, the test substance was investigated in a guinea pig skin sensitization test according to Buehler. 20 Pirbright-White guinea pigs in the treatment group and 10 animals in the control group were used. Dermal induction was performed using 100 % test item. The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone. Under the test conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = %).

Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.