Registration Dossier
Registration Dossier
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EC number: 944-283-7 | 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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The room temperature varied between 21°C and 25°C during the study procedure
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- None
Test material
- Reference substance name:
- [2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium
- EC Number:
- 276-702-8
- EC Name:
- [2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium
- Cas Number:
- 72496-90-3
- Molecular formula:
- C17H11CrN4O6S
- IUPAC Name:
- [2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- None
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Females (if applicable) nulliparous and non-pregnant: 30 females / 6 females, nulliparous and nonpregnant
- Age at study initiation: 5 -7 weeks
- Weight at study initiation: Control and Test Group 259 - 381 g Pretest 269 - 315 g
- Housing: Individually in Makrolon type-3 cages with autoclaved standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 342, Batch no. 63/94 guinea pig breeding/ maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water.
- Acclimation period: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 21 and 25 °C
- Humidity (%): 52 and 70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Test Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5% with bi-distilled water.
3) The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Control Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) Bi-distilled water
3)1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. - Day(s)/duration:
- Test Day 01
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % in bi-distilled water
- Day(s)/duration:
- Test Day 08
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % in vehicle
- Day(s)/duration:
- Test Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in test and 10 animals in control group
- Details on study design:
- None
- Challenge controls:
- None
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20041 is not a sensitiser.
- Executive summary:
A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20041 according to OECD Guideline 406 and EU Method B.6 (Skin Sensitisation).
No positive reactions were observed in the animals during the challenge phase either when treated with bidistilled water alone or when treated with the test article at 25 % in bidistilled water. FAT 20041 is therefore, classified as a non sensitiser in albino guinea pigs.
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