Registration Dossier

Administrative data

Description of key information

Skin sensitisation (in vivo, OECD 406, Bühler): not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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

Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Topical induction: 100 %
Topical challenge: 20%
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
Positive control results:
Sensitivity of test system periodically confirmed using alpha-hexylcinnamaldehyde as positive control.
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
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts was evaluated for potential skin sensitising effects in guinea pigs according to OECD Guideline 406 under GLP conditions using the methodology of Buehler (Clariant, 1994). Dermal induction was performed using 100% test material. The control group was exposed to the vehicle water only. Challenge treatment was carried out using a 20% test material solution (in water). Under the conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitisation incidence = 0%). Also none of the 10 control animals exhibited skin responses. Sensitivity of the test system is periodically confirmed using alpha-hexylcinnamaldehyde as positive control. Based on the results of this study, the test substance is considered to not be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.