Registration Dossier
Registration Dossier
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EC number: 950-485-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Dec 2010 to 16 Mar 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Deviations: animal number: 10 animals in the treatment group and 5 animals in the positive control group
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- yes
- Remarks:
- animal number: 10 animals in the treatment group and 5 animals in the positive control group
- GLP compliance:
- no
- Remarks:
- Remarks: Although not performed under GLP, the data are considered reliable and conclusive for hazard assessment and further testing does not appear scientifically according to Annex XI, 1.1.2 of Regulation (EC) No 1907/2006.
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed in Japan in 2010. At that date the Buehler test was accepted in Japan for testing skin sensitisation. The draft guidance for utilization of the LLNA test as a substitution method for sensitisation was not available in Japan before 2011. Since the considered experimental data are reliable and conclusive for hazard assessment, the data are considered to allow hazard evaluation of the skin sensitising properties of the target substance within this dossier to avoid additional testing.
Test material
- Reference substance name:
- 1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
- Molecular formula:
- C19H36O6
- IUPAC Name:
- 1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Kwl:Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals, Inc.
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 6 weeks
- Weight at study initiation: 325 - 420 g
- Housing: individually in metal wire cage (W266 × D266 × H200 mm: Riko Denki K.K.)
- Diet: RC4 (Oriental Yeast Co., Ltd., Lot No.: 100914, 101116), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance
- Day(s)/duration:
- 6 h on day 0, 7, 14, respectively
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 100% ethanol (control group)
- Day(s)/duration:
- 6 h on day 0, 7, 14, respectively
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 1% (w/w) 1-Chloro-2,4-dinitrobenzene (DNCB) (positive control)
- Day(s)/duration:
- 6 h on day 0, 7, 14, respectively
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance (test and control group)
- Day(s)/duration:
- 6 h
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10% (w/w) test substance (test and control group)
- Day(s)/duration:
- 6 h
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.25% (w/w) 1-Chloro-2,4-dinitrobenzene (DNCB) (positive control, test site b)
- Day(s)/duration:
- 6 h
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 100% ethanol (positive control, test site c)
- Day(s)/duration:
- 6 h
- No. of animals per dose:
- 10 (test group), 10 (control group), 5 (positive control group)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 epicutaneous (day 0, 7 and 14)
- Exposure period: 6 h exposure/day, respectively
- Test groups: 100% test substance
- Control group: ethanol
- Positive control group: 1% 1-Chloro-2,4-dinitrobenzene (DNCB) in ethanol
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0-14
B. CHALLENGE EXPOSURE
- No. of exposures: 1 epicutaneous
- Day(s) of challenge: 27 days after epicutaneous induction
- Exposure period: 6 h
- Test groups: 100% and 10% test substance
- Control group: 100% and 10% test substance
- Positive control group: 0.25% 1-Chloro-2,4-dinitrobenzene (DNCB) and ethanol
- Site: right flank
- Evaluation (hr after challenge): 24 and 48 h after removal of the challenge application - Challenge controls:
- The control group is actually a challenge control.
Positive control: 0.25% (w/w) DNCB and ethanol - Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- The positive control substance sensitization group was sensitized with 1% solution of DNCB followed by challenge treatments with a 0.25% DNCB solution and ethanol (vehicle). The positive control substance sensitization group showed an erythema score of 2 or 3 in all animals (5/5 animals) at 24 and 48 h after the challenge application of 0.25% DNCB solution, thus the positive rate was 100%. After challenge application of ethanol (vehicle), no skin reactions (0/5 animals) were observed at the end of the 24 and 48 h observation time point.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: ethanol, challenge: 100% and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 100%, challenge: 100% and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 1% DNCB, challenge 0.25%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 1% DNCB, challenge: 100% ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: ethanol, challenge: 100% and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 100%, challenge: 100% and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 1% DNCB, challenge 0.25%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 1% DNCB, challenge: 100% ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Table 1: Individual skin reactions
Group |
Substance for Induction (Concentration) |
Substance for Challenge (Concentration) |
Animal number |
Score 24 h observation time point |
Score 48 h observation time point |
Number of animals with positive reactions |
Test Group |
100% test substance |
100% test substance |
1101 |
0 |
0 |
0/10 |
1102 |
0 |
0 |
||||
1103 |
0 |
0 |
||||
1104 |
0 |
0 |
||||
1105 |
0 |
0 |
||||
1106 |
0 |
0 |
||||
1107 |
0 |
0 |
||||
1108 |
0 |
0 |
||||
1109 |
0 |
0 |
||||
1110 |
0 |
0 |
||||
10% test substance in ethanol |
1101 |
0 |
0 |
|||
1102 |
0 |
0 |
||||
1103 |
0 |
0 |
||||
1104 |
0 |
0 |
||||
1105 |
0 |
0 |
||||
1106 |
0 |
0 |
||||
1107 |
0 |
0 |
||||
1108 |
0 |
0 |
||||
1109 |
0 |
0 |
||||
1110 |
0 |
0 |
||||
Control group |
ethanol |
100% test substance |
2101 |
0 |
0 |
0/10 |
2102 |
0 |
0 |
||||
2103 |
0 |
0 |
||||
2104 |
0 |
0 |
||||
2105 |
0 |
0 |
||||
2106 |
0 |
0 |
||||
2107 |
0 |
0 |
||||
2108 |
0 |
0 |
||||
2109 |
0 |
0 |
||||
2110 |
0 |
0 |
||||
10% test substance in ethanol |
2101 |
0 |
0 |
|||
2102 |
0 |
0 |
||||
2103 |
0 |
0 |
||||
2104 |
0 |
0 |
||||
2105 |
0 |
0 |
||||
2106 |
0 |
0 |
||||
2107 |
0 |
0 |
||||
2108 |
0 |
0 |
||||
2109 |
0 |
0 |
||||
2110 |
0 |
0 |
||||
Positive control group |
1% DNCB in ethanol |
0.25% DNCB in ethanol |
3101 |
0 |
0 |
5/5 |
3102 |
0 |
0 |
||||
3103 |
0 |
0 |
||||
3104 |
0 |
0 |
||||
3105 |
0 |
0 |
||||
ethanol |
3101 |
0 |
0 |
0/5 |
||
3102 |
0 |
0 |
||||
3103 |
0 |
0 |
||||
3104 |
0 |
0 |
||||
3105 |
0 |
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.
- Conclusions:
- Challenge with 10% and 100% test substance formulation did not induce skin reactions in any animal in the conducted study. The test substance is not considered to exhibit skin sensitising properties.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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