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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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:
1994-09-12 to 1994-10-20
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed prior to LLNA implementation.
Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% / 0.5 mL
Day(s)/duration:
Test item applied three times (6 hour duration each), i.e. at day 1, day 8 and day 15
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
20% /0.5 mL
Day(s)/duration:
Day 29/6 hour dermal challenge followed by macroscopic assessment on day 30 and day 31
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Pretest: 2 animals/dose concentration (i. e. 6 animals total)
Control group: 10 animals
Treatment group: 20 animals
Challenge controls:
The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
aceton (w/v)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20 % test item in Aceton
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
aceton (w/v)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20 % test item in Aceton
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.
Executive summary:

In order to test for possible skin sensitizing effects, the test substance was investigated in a guinea pig skin sensitization test according to Buehler. 20 Pirbright-White guinea pigs in the treatment group and 10 animals in the control group were used. Dermal induction was performed using 100 % test item. The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone. Under the test conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = %).

Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In order to test for possible skin sensitizing effects, the test substance was investigated in a guinea pig skin sensitization test according to Buehler. 20 Pirbright-White guinea pigs in the treatment group and 10 animals in the control group were used. Dermal induction was performed using 100 % test item. The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone. Under the test conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = %).

Addtionally data of an human patch test performed in 50 young adult and adult people is available. Exposure was 24 hours. Readings were performed immediately after removal of plaster, 48 and 72 hours post application. On the basis of this test there is no evidence for any primary skin irritation or triggering an allergic reaction.

Based on the results of the OECD 406 study in guinea pigs the test substance registered showed no evidence for sensitizing properties. This result is supported by a human patch test. Thus, the test substance registered is not subject for labeling requirements with regard to skin sensitization.

Migrated from Short description of key information:
To assess the dermal irritation potential of the test substance one animal study according to the OECD 406 guideline (Buehler-test) is available. Additionally one human patch test performed in 50 young adult and adult people is available as supprotive data.

Justification for selection of skin sensitisation endpoint:
Well documented study according to OECD guideline 406 (Buehler test). Reliability 1

Justification for classification or non-classification

Based on the results of the OECD 406 study in guinea pigs the test substance registered showed no evidence for sensitizing properties. This result is supported by a human dermal patch test. Thus the test substance registered is not subject for labeling requirements with regard to skin sensitization.