Registration Dossier
Registration Dossier
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EC number: 271-756-9 | CAS number: 68607-24-9
Endpoint summary
Administrative data
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
- 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.
- 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.
Reference
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
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.
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