Registration Dossier
Registration Dossier
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EC number: 279-506-0 | CAS number: 80584-92-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-06-07 - 1982-08-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Valid guinea pig data are available, no further LLNA is necessary
Test material
- Reference substance name:
- 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)
- EC Number:
- 279-506-0
- EC Name:
- 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)
- Cas Number:
- 80584-92-5
- Molecular formula:
- C21H36N6O6.3C6H15NO3
- IUPAC Name:
- 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)
- Details on test material:
- - Physical state: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: in house bred
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 283 - 377 g
- Housing: individually in Macrolon cages
- Diet: ad libitum, standard guinea pig pellets (NAFAG No. 830, Gossau SG)
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 50±10
- Photoperiod (hrs dark / hrs light): 10/14
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- physiological saline
- Remarks:
- during 2nd and 3rd week the test substance was solved in a 1:1 mixture of normal vehicle and Freund complete adjuvant
- Concentration / amount:
- 0.1 %
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 %
- No.:
- #2
- Route:
- intradermal
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 30 %
- No. of animals per dose:
- 20 (10/sex)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Test groups: 2
- Control group: 1
- Site: right flank and the back
- Frequency of applications: every second day (except weekends)
- Duration: 3 weeks
- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE (INTRADERMAL)
- No. of exposures: 1
- Day(s) of challenge: 10 days
- Test groups: 2
- Control group: 1
- Site: right flank and the back
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24 hours
C. CHALLENGE EXPOSURE (EPICUTANEOUS, OCCLUSIVE)
- No. of exposures: 1
- Day of challenge: 24 hours
- Test groups: 2
- Control group: 1
- Site: right flank and the back
- Concentrations: 30 %
- Evaluation (hr after challenge): 24 hours - Challenge controls:
- Not available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Reading after intradermal exposure
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- other: Reading after intradermal exposure
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- other: Reading after epicutaneous occlusive exposure
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Reading:
- other: Reading after epicutaneous occlusive exposure
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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