Registration Dossier
Registration Dossier
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EC number: 201-818-2 | CAS number: 88-30-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-05-31 to 1990-08-16
- 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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Principles of method if other than guideline:
- According to Buehler et al., 1980
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was conducted before the implementation of OECD 429 in 2002.
Test material
- Reference substance name:
- α,α,α-trifluoro-4-nitro-m-cresol
- EC Number:
- 201-818-2
- EC Name:
- α,α,α-trifluoro-4-nitro-m-cresol
- Cas Number:
- 88-30-2
- Molecular formula:
- C7H4F3NO3
- IUPAC Name:
- α,α,α-trifluoro-4-nitro-m-cresol
- Reference substance name:
- 5-chloro-α,α,α-trifluoro-2-nitrotoluene
- EC Number:
- 204-280-7
- EC Name:
- 5-chloro-α,α,α-trifluoro-2-nitrotoluene
- Cas Number:
- 118-83-2
- Molecular formula:
- C7H3ClF3NO2
- IUPAC Name:
- 4-Chloro-1-nitro-2-(trifluoromethyl)benzene
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Reference substance name:
- 3-Carboxy-4-nitrophenol
- Cas Number:
- 610-37-7
- Molecular formula:
- C7H5NO5
- IUPAC Name:
- 3-Carboxy-4-nitrophenol
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
OTHER SPECIFICS: dark brown liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc.
- Microbiological status of animals, when known: SPF
- Age at study initiation: young adult
- Weight at study initiation: 446 - 550 g
- Housing: individually, in screen-bottom stainless steel cages
- Diet: ad libitum, certified guinea pig chow #5026 (Purina Mills, Inc.)
- Water: ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 1990-06-06 To: 1990-07-16
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 0.4 mL, 1.0 % w/v
- Day(s)/duration:
- day 0, day 7, and day 14; 6 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 0.4 mL, 0.1 % w/v
- Day(s)/duration:
- 2 weeks after last induction; 6 h
- No. of animals per dose:
- Test group: 10
Naive control group: 10
positive control group: 4 - Details on study design:
- RANGE FINDING TESTS:
yes, two range finding groups, 4 animals each.
1st group: undiluted, 75 % w/v, 50 % w/v, 25 % w/v
Due to the level of irritation, a second range finding study ws conducted
2nd group: 10 % w/v, 5 % w/v, 1 % w/v, 0.1 % w/v
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 1
- Control group: 2, naive and positive control
- Site: back of the animals
- Frequency of applications: once a week
- Duration: 3 week
- Concentrations: 1.0 % w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the last inducton exposure
- Exposure period: 6 h
- Test groups: 1
- Control group: 2, naive and positive control
- Site: back of the animals
- Concentrations: 0.1 % w/v
- Evaluation (hr after challenge): 24, 48 - Positive control substance(s):
- yes
- Remarks:
- 0.3 % w/v 2,4-dinitrochlorobenzene (DNCB) in 80 % ethanol/deionized water
Results and discussion
- Positive control results:
- The mean score of DNCB (all animals) 24 h after challenge was 2.0 (max. score 3.0).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- subcutanous hemorrhaging, possible necrotic areas
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- subcutanous hemorrhaging, possible necrotic areas
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed no skin sensitizing potential.
- Executive summary:
In a primary sensitisation study similar to OECD guideline 406, a group of young adult Dunkin-Hartley guinea pigs (10♂, 446 - 550 g) were epicoutanously treated with the test substance (3x 0.4 mL, 1.0 % w/v in deionized water, once a week for 6 h) at the back (Hazleton Laboratories, 1990). After an incubation period of 2 weeks, the animals were challenged with 0.4 mL of a 0.1 % w/v water solution for 6 h at the back. Readings were done 24 and 48 h after the challenge injection. The sensitizing score was determined according to Buehler et al. (1980). The test substance caused no sensitisation response. A positive control group of 4 animals was treated with 2,4-dinitrochlorobenzene (0.3 % w/v in 80 % ethanol/dionized water). All animals of the positive control group showed signs of sensitisation.
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