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Toxicological information

Skin sensitisation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17, 1992
Deviations:
no
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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100 % in deionized water
Challenge: 100 % in deionized water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
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)

Resultsopen allclose all
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.
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.
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.
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.