Registration Dossier
Registration Dossier
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EC number: 701-385-4 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When the study was performed, the LLNA did not yet exist as an OECD testing guideline.
Test material
- Reference substance name:
- Reaction products of Benzeneamine, N-phenyl- with nonene (branched)
- EC Number:
- 701-385-4
- Cas Number:
- 36878-20-3
- Molecular formula:
- C21H29N - C30H47N (main constituents)
- IUPAC Name:
- Reaction products of Benzeneamine, N-phenyl- with nonene (branched)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test material name: Naulube 348L
Description: black very viscous liquid
Storage at room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation:336 - 410g
- Housing:up to three per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 - 22°C
- Humidity (%): 37 - 58%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 25%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: mixture of Freund's Complete Adjuvant plus arachis oil
- Concentration / amount:
- 25%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 test group
10 control group - Details on study design:
- RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x intradermal and 1x epicutaneous
- Exposure period: 48h for epicutaneous exposure
- Test groups: see table
- Control group: vehicle
- Site: shoulder region
- Frequency of applications:
- Duration: 21 days
- Concentrations: see table
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24h
- Test groups: yes
- Control group: yes
- Site: flanks
- Concentrations: see table
- Evaluation (hr after challenge): 24h and 48h
- Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2.4-DINITROCHLOROBENZENE tested in January 1993
Results and discussion
- Positive control results:
- 90% (9/10 guinea pigs) after challenge with 0.25% in ethanol.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
Any other information on results incl. tables
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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