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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
An in vivo skin sensitisation study is available that was performed prior to 1 June 2008. In accordance with Regulation (EC) No. 1907/2006, the data were included to avoid unnecessary testing.

Test material

Constituent 1
Reference substance name:
Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
EC Number:
263-174-9
EC Name:
Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
Cas Number:
61791-42-2
Molecular formula:
UVCB
IUPAC Name:
Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
Test material form:
semi-solid (amorphous): gel
Remarks:
paste

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG. SPF breeding (Hoe:DHPK[SPFLac])
- Weight at study initiation: 299 g (264 - 327 g)
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Topical induction: 100 %
Topical challenge: 20%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Topical induction: 100 %
Topical challenge: 20%
No. of animals per dose:
20 (test group)
10 (control group)
Details on study design:
RANGE FINDING TESTS: yes, determination of primary irritating and non-irritating concentration

Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:
Sensitivity of test system periodically confirmed using alpha-hexylcinnamaldehyde as positive control.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Group:
positive control
Dose level:
no reading
No. with + reactions:
0
Total no. in group:
0

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.