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Description of key information

The skin sensitization property was investigated according to the guideline OECD 406 (Bühler test). The registration substance is a non-sensitizer.

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:
11 July 1995 to 4 September 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed before the LLNA was available as the test method.
Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
-Strain specifics: Hoe: DHPK (SPFLac)
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Weight at study initiation: mean 360 g (range: 314-386 g)
- Housing: in groups of five animals in Makrolon type 4 cages in fully air-conditioned rooms
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: not necessary (breeding at identical conditions)
- Randomisation: randomisation scheme 95.0199

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light):12/12
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol:water 80:20 for induction and isopropanol for challenge
Concentration / amount:
Epicutaneous induction:
20% in ethanol:water 80:20
Epicutaneous challenge:
0.8% in isopropanol
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol:water 80:20 for induction and isopropanol for challenge
Concentration / amount:
Epicutaneous induction:
20% in ethanol:water 80:20
Epicutaneous challenge:
0.8% in isopropanol
No. of animals per dose:
20 animals in the treatment group
10 animals in the control group

6 animals in the group for determination of a primary non-irritant concentration
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 dermal applications
- Exposure period: dermal application on days 1, 8 and 15 (occlusive, bandage removed after 24 hours)
- Site: left flank, hair was shaved, 0.5 ml test substance (treatment group) or 0.5 ml vehicle (control gorup) was put evenly on 2x2 cm gauze pad, was put on the skin and occlusively fixed with polyethylene foil and elastic bandage. Aafter 24 hours, bandage was removed and skin site was washed with lukewarm water
- Frequency of applications and duration: see above
- Concentrations: see above

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 29
- Exposure period: occlusive for 6 hours
- Test groups: test substance
- Control group: test substance
- Site: right flank
- Concentrations: see above
- Evaluation (hours after challenge): 24 and 48 hours after patch removal
Challenge controls:
10 animals treated with induction vehicle during induction phase and with test substance in challenge vehicle in challenge phase
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.8%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical signs of intoxication, normal body weight development
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.8%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs of intoxication, normal body weight development.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs of intoxication, normal body weight development
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs of intoxication, normal body weight development.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.8%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical signs of intoxication, normal body weight development
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.8%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs of intoxication, normal body weight development.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs of intoxication, normal body weight development
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs of intoxication, normal body weight development.

Irritation readings during induction phase (24 hours after patch removal)

Control animals No. 1 2 3 4 5 6 7 8 9 10

Treatment animals No. 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

1. Induction treatment (day 1)

Control animals

Erythema 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0

Treatment animals

Erythema 1 1 2 1 1 2 1 1 1 1 2 1 1 1 2 1 1 1 1 1

Edema 0 0 1 0 0 1 0 0 0 0 1 1 0 0 1 0 1 0 0 0

2. Induction treatment (day 8)

Control animals

Erythema 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0

Treatment animals

Erythema 2 2 2 2 2 2 2 2 1 2 2 2 2 2 1 2 1 2 2 2

Edema 1 1 1 0 1 1 0 1 0 1 0 1 1 1 0 1 0 1 1 1

3. Induction treatment (day 15)

Control animals

Erythema 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0

Treatment animals

Erythema 2 2 1 2 2 2 1 2 1 1 1 1 2 2 2 2 2 1 1 2

Edema 1 1 0 1 1 1 0 1 0 0 0 0 1 1 0 0 1 0 0 1

Skin readings after challenge treatment (day 29)

1. reading (24 hours)

Control animals

Erythema 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0

Treatment animals

Erythema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

2. reading (48 hours)

Control animals

Erythema 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0

Treatment animals

Erythema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Edema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The skin sensitization property was investigated according to the guideline OECD 406 (Bühler test). The registration substance is a non-sensitizer.
Executive summary:

The skin sensitization property was investigated according to the guideline OECD 406 (Bühler test).

Three epicutaneous induction was carried out at concentration of 20% in ethanol:water 80:20. Challenge treatment was carried out at 0.8% in isopropanol. No of 20 animals treated showed a positive skin response. No significant skin sensitizing property was found.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No significant skin sensitizing property was found in Bühler test. No classification is warranted.