Registration Dossier
Registration Dossier
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EC number: 679-769-5 | CAS number: 2675-94-7
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
The test item is considered to have no skin sensitizing potency in guinea pigs by
Buehler test
.
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:
- From 2013-09-25 to 2013-11-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was initiated to fulfil substance notification need for jurisdictions outside of EU, in which OECD 406 is an acceptable method for skin sensitisation study.
- Specific details on test material used for the study:
- Batch No.: not specified
Purity: 99.95% - Species:
- guinea pig
- Strain:
- other: ElmSam: HA, SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Samtako Bio Korea., Ltd.
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 315.69 ~ 377.49 g
- Housing: five animals per cage were housed in stainless steel cage
- Diet: be fed pellet diet for experimental guinea pig including 0.01% ascorbic acid
- Water: be given the filltered and UV irradiated water libtium
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 10~15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- Day 0, 7, 14
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 100% test substance
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- Day 27
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 for treament, 10 for negative and positive control group
- Details on study design:
- RANGE FINDING TESTS:
-Dose level: the concentration of test substance were 4 types, 50% (v/v), 25%(v/v), 12.5%(v/v) including the highest concentration [100%; test substance] with vehicles by using a common ratio 2.
-Determination of dose levels: in the preliminary test using two animals per concentration, skin reaction were not observed at 100% concentration (test substance itself). Based on this result, concentration of 100% concentration was chosen for induction and challenge phase of the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hour , Day 0, 7, 14
- Test groups: 100% test substance
- Control group: D.W. and 1 %(w/v) DNCB
- Site: the fur on one flank was closely with a hair clipper
B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 27
- Exposure period: 6 hours
- Test groups: 100% test substance
- Control group: D.W. and 1 %(w/v) DNCB
- Site: test area (the fur on one flank was closely with a hair clipper)
- Challenge controls:
- Negative control: 100% test substance
Positive control: 1%(w/v) DNCB - Positive control substance(s):
- yes
- Remarks:
- DNCB
- Positive control results:
- In the positive control group, skin reaction of erythema was shown and sensitization index (the mean score of skin reaction) was 1.1 (24 hours) and 0.6 (48 hours). Also, the frequency index (sensitization) was 80.0% (24 hours) and 60.0% (48 hours).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormalities detected
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormalities detected
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result indicate that the test item is considered to have no skin sensitizing potency in guinea pigs by Buehler test under the conditions of this study.
- Executive summary:
The study was conducted to evaluate the skin sensitization of test item in guinea by Buehler test according to OECD 406 (1992). Parameters measured during the study period were mortality, clinical signs, body weight changes and skin reaction. The following results were obtained:
- No treatment-related mortality was observed during the study period.
- No treatment related clinical signs were observed in any treated animals.
- All living animals in treatment group showed a normal increase of body weight.
- At the 24 and 48 hours after challenge with test substance of 100%, the sensitization index (mean score of skin reaction) and frequency index (sensitization rate) were 0.0, 0.0 and 0.0 % and 0.0% at 24 and 48 hours for the test substance. In positive control, the sensitization index (mean score of skin reaction) and frequency index (sensitization rate) were 1.1, 0.6 and 80.0%, 60.0% at 24 and 48 hours after challenge, respectively.
These results indicate that the test item is considered to have no skin sensitizing potency in guinea pigs by Buehler test under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Buehler test: negative.
Therefore, according to Regulation (EC) 1272/2008 (amendment 286/2011), table 3.4.2, this substance should not be classified for skin sensitisation endpoint.
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