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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
other: Test performed under GLP similar to guideline with acceptable restrictions. Read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 group
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 group
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 group
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:
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:
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:

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.