Sunflower oil, ester with sorbitol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

First addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 406, "Skin Sensitisation" adopted July 17, 1992

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Justification for non-LLNA method:

The registration substance is esters of unsaturared fatty acids. Unsaturated fatty acids are known to induce false positive responce in LLNA (i.e. Roberts et al., Regul Toxicol Pharmacol. 2016 Oct;80:260-7; Kreiling et al., Food Chem Toxicol. 2008 Jun;46(6):1896-904):

Test material

Test material information

Constituent 1

Reference substance name:

Sunflower oil, ester with sorbitol

EC Number:

306-248-9

EC Name:

Sunflower oil, ester with sorbitol

Cas Number:

96690-53-8

IUPAC Name:

sunflower seed oil sorbitol esters

Test material form:

liquid

Details on test material:

Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100% / 0.5 mL

Day(s)/duration:

6h /weekly for three weeks

Adequacy of induction:

other: In the prelliminary test no significant irritation was found up to the concentration of 100%.

Challenge

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100 %/ 0.5mL

Day(s)/duration:

6hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

20 for test group, 10 for negative control group

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

other: reading at 24/48/72h after challenge treatment

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

other: reading at 24/48/72h after challenge treatment

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Remarks:

Vaseline was used as negative control

Any other information on results incl. tables

Number of animals showing skin reactions after
Challenge concentration of test substance (%)			First challenge			Second challenge
	First challenge	Second challenge	24h	47h	72h	24h	47h	72h
Test group	100	-	0	0	0	-	-	-
Negative control group	100	-	0	0	0	-	-	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The skin sensitization property fo the registration substance was investigated using Bühler Test according to the Guideline OECD 406. No significant skin sensitization property was found.

Executive summary:

The skin sensitization property fo the registration substance was investigated using Bühler Test according to the Guideline OECD 406. The undiluted substance was applied to 20 guinea pigs epicutaneously for 6 hours once per week for three weeks, at volume of 0.5mL. After two weeks the animals were challenged by epicutaneous treatment of 0.5mL of undiluted substance for 6hours. None of these animals responded at reading times 24, 48h and 72h after treatment. No significant skin sensitization property was found for the registration substance.