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EC number: 206-564-6 | CAS number: 354-58-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1984-03-07 to 0985-01-25
- 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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- application of the test item in the induction phase was topical only
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A study according to OECD Guideline 406 was already available before the decision to register the substance under REACH was taken.
Test material
- Reference substance name:
- 1,1,2-trichlorotrifluoroethane
- EC Number:
- 200-936-1
- EC Name:
- 1,1,2-trichlorotrifluoroethane
- Cas Number:
- 76-13-1
- IUPAC Name:
- 1,1,2-trichloro-1,2,2-trifluoroethane
- Details on test material:
- - Molecular formula: C2Cl3F3 (identical to submission substance)
- Molecular weight: 187.376 g/mol (identical to submission substance)
- Smiles notation: ClC(F)(F)C(Cl)(Cl)F (different from submission substance)
- InChl: InChI=1S/C2Cl3F3/c3-1(4,6)2(5,7)8 (different from submission substance)
- Structural formula: see attachment CAS_76-13-1_Structure.png (under "Illustration (picture/graph)")
- Physical state: 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: Charles River Breeding Laboratories
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 300-500 g
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 7 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4 (on test days 1, 3, 5, and 7)
- Exposure period: 48 h
- Test groups: 10 animals
- Control group: 5 animals per control (positive and negative control)
- Site: upper left back
- Concentrations: undiluted
On test day 5, Freud's Complete Adjuvant was applied intradermally adjacent to the application site.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: test day 20
- Exposure period: 24 h
- Test groups: 10 animals
- Control group: 5 animals per control (positive and negative control)
- Site: upper right back
- Concentrations: undiluted
- Evaluation (hr after challenge): 24, 48, and 72 h after challenge
SCORING SYSTEM
0 - no visible reaction
1 - very slight erythema or edema
2 - slight erythema or edema
3 - moderate erythema or edema
4 - marked erythema or edema
Any animal showing a reaction of 2 or greater foer erythema and/or edema in the challenge phase is considered sensitized. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (0.1% in acetone)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Mean erythema score: 0.1/4, mean edema score: 0/4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score: 0.1/4, mean edema score: 0/4.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Mean erythema score: 0/4, mean edema score: 0/4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score: 0/4, mean edema score: 0/4.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Mean erythema score: 0/4, mean edema score: 0/4
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score: 0/4, mean edema score: 0/4.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Mean erythema score: 3.2/4, mean edema score: 1.6/4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Mean erythema score: 3.2/4, mean edema score: 1.6/4.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Mean erythema score: 2.6/4, mean edema score: 1.8/4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Mean erythema score: 2.6/4, mean edema score: 1.8/4.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Mean erythema score: 2.6/4, mean edema score: 2.0/4
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Mean erythema score: 2.6/4, mean edema score: 2.0/4.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- untreated
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Mean erythema score: 0/4, mean edema score: 0/4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: untreated. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Mean erythema score: 0/4, mean edema score: 0/4.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- untreated
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Mean erythema score: 0/4, mean edema score: 0/4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: untreated. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Mean erythema score: 0/4, mean edema score: 0/4.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- untreated
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Mean erythema score: 0/4, mean edema score: 0/4
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: untreated. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Mean erythema score: 0/4, mean edema score: 0/4.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The skin sensitisation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed using the in vivo Guinea Pig Maximisation Test. Results showed no effects after challenge with the test substance. No skin reactions were observed 1, 2, or 3 days after challenge except for a very slight erythema on one animal 24 h after challenge. Thus the test substance is not a skin sensitizer.
The skin sensitisation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the in vivo Guinea Pig Maximisation Test with the source chemical 1,1,2-trichloro-1,2,2-trifluoroethane. The analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf). As a consequence 1,1,1-trichloro-2,2,2-trifluoroethane is not considered as a skin sensitiser. - Executive summary:
The skin sensitisation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed using the in vivo Guinea Pig Maximisation Test. Results showed no effects after challenge with the test substance. No skin reactions were observed 1, 2, or 3 days after challenge except for a very slight erythema on one animal 24 h after challenge. Thus the test substance is not a skin sensitizer.
The skin sensitisation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the in vivo Guinea Pig Maximisation Test with the source chemical 1,1,2-trichloro-1,2,2-trifluoroethane. The analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf). As a consequence 1,1,1-trichloro-2,2,2-trifluoroethane is not considered as a skin sensitiser.
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