Registration Dossier
Registration Dossier
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EC number: 810-418-2 | CAS number: 1703784-30-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2019 - October 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no positive control group was included in this study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This type of test method was requested by Chinese authorities for chemical registration in China.
Test material
- Reference substance name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- EC Number:
- 810-418-2
- Cas Number:
- 1703784-30-8
- IUPAC Name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Liaoning Changsheng Biology Technology Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]
- Microbiological status of animals, when known:
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40.35-70.00
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50% (V/V); 0.2 ml solution
- Day(s)/duration:
- day 0, day 7, day 14 each for 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 0.2 ml 25% test solution
- Day(s)/duration:
- day 28 for 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in the treated group
10 animals in the control group - Details on study design:
- RANGE FINDING TESTS: 2 animals were used,
application of 0.2 ml of 50% test solution to the left flank of the first animal.
application of 0.2 ml of 25% test solution to the left flank of the second animal.
application of 0.2 ml of 12.5% test solution to the right flank of the second animal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: day 0, day 7, day 14
- Test groups: one group of 20 animals
- Control group: 10 animals
- Site: left flank
- Duration: 6 hours
- Concentrations: 50% for the test group, vehicle only for the control group
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: one group of 20 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 25% for the both groups
- Evaluation (hr after challenge): on 24 hours and 48 hours after removing the challenge exposure patch
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema
- Remarks on result:
- other: incidence of the treated group is 10%
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under this test conditions, based on the findings and the evaluation system used, the sensitization incidence of the test item is 10%.
Therefore the test substance is a mild sensitizer, but no classification needed.
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