Registration Dossier

Administrative data

Description of key information

Skin Irritation/Corrosion:

not irritating to an in vitro skin model (EpiSkin), tested with 1,1,1-trichloro-2,2,2-trifluoroethane (Dreher 2010)

not corrosive/irritating to the skin in in vivo tests with 1,1,2-trichloro-1,2,2-trifluoroethane (Morrow 1976, Duprat 1976 and Desoille 1968)

Eye Irritation/Corrosion:

not irritating to rabbit eyes, in vivo tests with 1,1,2-trichloro-1,2,2-trifluoroethane (Reinke 1962 and Duprat 1976)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
unsuitable test system
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please find the hypothesis for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please find the description of the source chemical R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and the target R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

3. ANALOGUE APPROACH JUSTIFICATION
Please find the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Irritant / corrosive response data:
No difference between the areas treated with the test item and the respective control areas could be observed after 20 weeks of treatment.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize et al., J Pharmacol and Exp Therapeutics 1944, 82: 377–90
Conclusions:
The skin irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on rabbits 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 irritating to rabbit skin.
Executive summary:

Please find the explanation of and the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

The test substance 1,1,2-trichloro-1,2,2-trifluoroethane was applied to the shaved back of 3 Albino rabbits daily for a period of 20 weeks (according to method of Draize, Woodard, and Calvery). After 20 weeks application to rabbit skin, no changes could be observed compared to the test area. Thus the test substance is not considered as irritating to rabbit skin.

The skin irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on rabbits 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 irritating to rabbit skin.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Protocol signed: 2010-09-03, experimental start date: 2010-09-08, experimental termination date: 2010-09-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
Qualifier:
according to guideline
Guideline:
other: B46 of Council Regulation (EC) No 761/2009
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Species:
other: In vitro using EpiSkin inserts (3-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum, supplied by SkinEthic Laboratories, Nice, France)
Strain:
other: Not applicable
Type of coverage:
other: Not applicable
Preparation of test site:
other: Not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: Not applicable
Amount / concentration applied:
40 µL
Duration of treatment / exposure:
15 minutes
Observation period:
Not applicable
Number of animals:
Not applicable
Irritation / corrosion parameter:
other: other: viability of tissues
Value:
87.2
Remarks on result:
other:
Remarks:
Time point: 15 mins treatment. (migrated information)

Based on the cell viability measurements obtained, the following mean viability measurements for the test article, negative control and positive control were calculated to be: 87.2%, 100% and 7.2% respectively.

 

These results indicate the viability of the epidermal tissue was not reduced to below 50% of the negative control and therefore may be considered to be non-irritant. The positive control showed an appropriate response in the assay system.

 

No other test substance related effects were observed.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was not irritant to the in vitro skin model EpiSkin.
Executive summary:

In order to assess the in vitro skin irritation potential of 1,1,1-trichloro-2,2,2-trifluoroethane, EpiSkin inserts were treated with the test substance, negative control (phosphate buffered saline (PBS)) and positive control (5% v/v sodium dodecyl sulphate (SDS)) for 15 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT (3-(4, 5-Dimethylthiazol-2-yl) -2, 5-diphenyltetrazolium bromide, also known as Thiazolyl blue) interacting substances assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment.

 

The group mean viability for the test article was 87.2%, for the negative control was 100% and for the positive control was 7.2%.

 

The test substance was not irritant to the in vitro skin model EpiSkin.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please find the hypothesis for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please find the description of the source chemical R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and the target R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

3. ANALOGUE APPROACH JUSTIFICATION
Please find the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0.2
Irritant / corrosive response data:
The test item has practically no effect on rabbit skin (macroscopical and microscopical observation). The calculated primary skin irritation index was 0.2 (8 being the maximum score).
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on rabbits 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 irritating to rabbit skin.
Executive summary:

Please find the explanation of and the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

Dermal irritation/corrosion of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed in an in vivo test on six rabbits. Results revealed that the test item is practically not irritating showing a primary dermal irritation score of 0.2 (it is assumed that the maximum value is 8). Thus the test substance is not considered as irritating to rabbit skin.

The skin irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on rabbits 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 irritating to rabbit skin.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The available documentation of this study, which was performed 1976, is limited. However the study is scientifically valid and the results are reliable. There is no need to repeat this vertebrate study. Read-across.
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please find the hypothesis for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please find the description of the source chemical R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and the target R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

3. ANALOGUE APPROACH JUSTIFICATION
Please find the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
other: skin corrosion
Basis:
other: animals #1 - #6
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Number of rabbits with skin corrosion: 0/6
Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: other: US Department of Transportation, Hazardous Materials regulations, Title 49 CFR, Section 173.240(a)(i), from October 1975
Conclusions:
The skin corrosion potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on rabbits 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 corrosive to rabbit skin.
Executive summary:

Please find the explanation of and the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

The test substance 1,1,2-trichloro-1,2,2-trifluoroethane was tested on skin corrosive properties in a test similar to OECD 404 with some deviations (e.g. only skin corrosion but not irritation was tested). None of the 6 animals used for the test showed skin corrosion after 4 h exposure to the test item under occlusive conditions. Thus the test substance is not considered as corrosive to rabbit skin.

The skin corrosion potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on rabbits 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 corrosive to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please find the hypothesis for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please find the description of the source chemical R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and the target R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

3. ANALOGUE APPROACH JUSTIFICATION
Please find the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
110
Irritant / corrosive response data:
The test item 1,1,2-trichloro-1,2,2-trifluoroethane showed practically no effect on the eyeball. Histopathologic examination showed only a slight augmentation of the corneal epithelium.
Interpretation of results:
not irritating
Conclusions:
The eye irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on six rabbits 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 irritating to the eyes.
Executive summary:

Please find the explanation of and the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

The eye irritation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed in an in vivo test on six rabbits. Results revealed that the test item is not irritating showing a primary dermal irritation score of 0.2 (with 110 being the maximum value). The only alteration observed was a slight augmentation of the corneal epithelium. Thus the test item is not irritating to rabbit eyes.

The eye irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on six rabbits 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 irritating to rabbit eyes.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The available documentation of this study, which was performed 1962, is limited. However the study is scientifically valid and the results are reliable. There is no need to repeat this vertebrate study.
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please find the hypothesis for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please find the description of the source chemical R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and the target R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

3. ANALOGUE APPROACH JUSTIFICATION
Please find the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal: #2, #3, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
Group 1 (i.e. eyes washed 20 seconds after exposure, animals #1 - #3): Mild conjunctivitis was observed in one of three animals at 24 h. Effects were completely reversible within 48 h (i.e. all eyes normal at 48 h and 72 h after eposure)
Group 2 (i.e. eyes not washed, animals #4 - #6): minimal corneal dullness was observed in one of three animals at 24 h. Effects were completely reversible within 48 h (i.e. all eyes normal at 48 h and 72 h after eposure)
No other adverse effects (chemosis, iritis) observed.
Interpretation of results:
not irritating
Conclusions:
The eye irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on Albino rabbits 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 irritating to rabbit eyes.
Executive summary:

Please find the explanation of and the justification for the read across between R113 (1,1,2-trichloro-1,2,2-trifluoroethane ) and R113a (1,1,1-trichloro-2,2,2-trifluoroethane ) for all relevant endpoints in the document "Analogue approach report for 1,1,1-trichloro-2,2,2-trifluoroethane – read-across from 1,1,2-trichloro-1,2,2-trifluoroethane" in section 13.2, under entry "Assessment Reports_Read-Across" (please see also under cross reference).

The eye irritation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed in an in vivo test on Albino rabbits. The test substance was applied to the eyes of 3 Albino rabbits per group which were either washed after 20 seconds of exposure or remained unwashed. In the animals without washing, minimal corneal dullness was observed in one of three animals at 24 h; when washed after 20 seconds, the test item caused mild conjunctivitis in one of three animals at 24 h. All effects were completely reversible within 48 h. Thus the test substance is considered to be not irritating to rabbit eyes.

The eye irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from an in vivo test on Albino rabbits 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 irritating to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion/irritation

The skin irritation potential of 1,1,1-trichloro-2,2,2-trifluoroethane was assessed in an in vitro skin model (EpiSkin). The test substance was not irritant to the in vitro model.

In addition some further tests with the test substance 1,1,2-trichloro-1,2,2-trifluoroethane are available (read-across), which contribute to the assessment of the skin corrosion/irritation potential by the weight-of-evidence.

The corrosion/irritation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed with in vivo tests on rabbits. The test item was not corrosive/irritating to rabbit skin.

The skin corrosion/irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from in vivo tests on rabbits 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 corrosive/irritating to the rabbit skin.

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2, the available data for skin corrosion/irritation potential is considered to be adequate for the purposes of risk assessment, and classification and labelling, based on the weight-of-evidence.

Eye irritation

The eye irritation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed with in vivo tests on rabbits. The test item was not irritating to rabbit eyes.

The eye irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from in vivo tests on rabbits 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 irritating to the rabbit eyes.

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2, the available data for eye irritation potential is considered to be adequate for the purposes of risk assessment, and classification and labelling, based on the weight-of-evidence.

Justification for classification or non-classification

The substance was not irritant to skin and eyes. As a result the substance does not meet the criteria for classification (corrosive, irritant, inflammation of the skin, ocular lesions) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.5 and 3.2.6.

The substance was not irritant to skin. As a result the substance does not meet the criteria for classification (skin corrosion/irritation) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.2.

The substance was not irritant to eyes. As a result the substance does not meet the criteria for classification (serious eye damage/eye irritation) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.3.