Esterification products of fatty acids, C16-18 (even numbered) and C18 (unsaturated) with triethanolamine, dimethyl sulphate-quaternized

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

2002-01-29 to 2002-03-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across from a guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report Date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

July 17, 1992

Deviations:

no

Test guideline 2

Qualifier:

according to

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

July 30, 1996

GLP compliance:

yes

Type of study:

Buehler test

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Mol:DH (Moellegaard)

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

Induction: 100 % in deionized water
Challenge: 100 % in deionized water

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Induction: 100 % in deionized water
Challenge: 100 % in deionized water

No. of animals per dose:

3 ‐ preliminary study
10 – main study control
20 – main study treatment

Details on study design:

PRELIMINARY STUDY AND DOSE RANGE FINDING
Left flank: 20 % (in deinonized water), 100% (moistened)
Right flank: 4, 20% (in deinonized water)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions

INDUCTION
100% (non‐irritating)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions, three times at intervals of one week. Skin grading 24 and 48h following patch removal

CHALLENGE
100% (non‐irritating); 14 days after the last induction exposure, application of the challenge patch on the shaved skin for 6h; skin evaluations 24 and 48h after patch removal

GRADING SYSTEM
Dermal reactions graded for erythema and edema by blind reading according to grading scale:
- No visible change: 0
- Discrete or patchy erythema: 1
- Moderated and confluent erythema: 2
- Intense erythema and swelling: 3
- not assessable: ?

Positive control substance(s):

yes

Remarks:

Alpha-hexylcinnamic aldehyde

Results and discussion

Positive control results:

The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the
Bühler test. No unforeseen circumstances were observed which might have affected the quality or integrity of the study.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test group

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

1st reading

Hours after challenge:

48

Group:

test group

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 4

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

PRELIMINARY STUDY AND DOSE RANGE FINDING

No irritation at any dose. Concentration for induction and challenge: 100%

MAIN STUDY

No skin reaction observed in the control and test animals treated at the test item at 100% in de‐ionized water.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test substance "fully saturated TEA-Esterquat" is not a dermal sensitizer in this study.

Executive summary:

In a dermal sensitization study with the fully saturated TEA-Esterquat, (containing approx 15 % IPA) male Moellegaard guinea pigs were tested using the method of Bühler according to OECD guideline 406. Positive control material was alpha-hexylcinnamic aldehyde.

Dermal induction was performed with undiluted test substance. None of the animals of the test or control group showed any positive skin reactions after challenge treatment with the undiluted test substance. The sensitisation rate at 24 h and at 48 h was 0 %.

 

In this study the test substance, “fully saturated TEA-Esterquat”, is considered to be a non-sensitizer.