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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation (bacterial):

negative results in 3 in vitro bacterial gene mutation tests (Ames) based on read across from 1,1,2-trichloro-1,2,2-trifluoroethane (R113); Barsky 1976, Russel 1977 and Longstaff 1984

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: positive controls only tested with strains TA1535 and TA100
Conclusions:
The test item 1,1,2-trichloro-1,2,2-trifluoroethane was non-mutagenic in the 5 strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98, and TA100) tested with and without metabolic activation.
 
Remark of the registrant:
According to OECD TG 471 the test should be performed with (at least) five strains: i.e. with four S. typhimurium strains with GC base pairs at the primary reversion site (e.g. TA1535, TA1537, TA98 and TA100) and with one strain with an AT base pair at the primary reversion site (e.g. E. coli WP2 or S. typhimurium TA102). The latter strain is needed in order to detect certain oxidising mutagens, cross-linking agents and hydrazines. This study has been performed with the four strains TA1535, TA1537, TA98 and TA100, but not with the additional AT base pair containing strain. Neither 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) nor 1,1,1-trichloro-2,2,2-trifluoroethane (target chemical) is an oxidising substance or is a hydrazine. In addition, based on their chemical structure, both chemicals are not expected to have cross-link capabilities. Thus the lack of testing with the additional strain does not significantly restrict the reliability, relevance and adequacy of this study.
 
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 item 1,1,2-trichloro-1,2,2-trifluoroethane was non-mutagenic in the 5 strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98, and TA100) tested with and without metabolic activation.

 

Remark of the registrant:

According to OECD TG 471 the test should be performed with (at least) five strains: i.e. with four S. typhimurium strains with GC base pairs at the primary reversion site (e.g. TA1535, TA1537, TA98 and TA100) and with one strain with an AT base pair at the primary reversion site (e.g. E. coli WP2 or S. typhimurium TA102). The latter strain is needed in order to detect certain oxidising mutagens, cross-linking agents and hydrazines. This study has been performed with the four strains TA1535, TA1537, TA98 and TA100, but not with the additional AT base pair containing strain. Neither 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) nor 1,1,1-trichloro-2,2,2-trifluoroethane (target chemical) is an oxidising substance or is a hydrazine. In addition, based on their chemical structure, both chemicals are not expected to have cross-link capabilities. Thus the lack of testing with the additional strain does not significantly restrict the reliability, relevance and adequacy of this study.

 

The bacterial mutagenicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the Ames 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).

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
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
Type of assay:
bacterial reverse mutation assay
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
The test item 1,1,2-trichloro-1,2,2-trifluoroethane was non-mutagenic in the 4 strains of Salmonella typhimurium (TA1535, TA1538, TA98, and TA100) tested with and without metabolic activation.

Remark of the registrant:
According to OECD TG 471 the test should be performed with (at least) five strains: i.e. with four S. typhimurium strains with GC base pairs at the primary reversion site (e.g. TA1535, TA1537, TA98 and TA100) and with one strain with an AT base pair at the primary reversion site (e.g. E. coli WP2 or S. typhimurium TA102). The latter strain is needed in order to detect certain oxidising mutagens, cross-linking agents and hydrazines. This study has been performed with the four strains TA1535, TA1538 (instead of TA1537, recommended by the guideline), TA98 and TA100, but not with the additional AT base pair containing strain. Neither 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) nor 1,1,1-trichloro-2,2,2-trifluoroethane (target chemical) is an oxidising substance or is a hydrazine. In addition, based on their chemical structure, both chemicals are not expected to have cross-link capabilities. Thus the lack of testing with the additional strain does not significantly restrict the reliability, relevance and adequacy of this study.
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 item 1,1,2-trichloro-1,2,2-trifluoroethane was non-mutagenic in the 4 strains of Salmonella typhimurium (TA1535, TA1538, TA98, and TA100) tested with and without metabolic activation.

Remark of the registrant:

According to OECD TG 471 the test should be performed with (at least) five strains: i.e. with four S. typhimurium strains with GC base pairs at the primary reversion site (e.g. TA1535, TA1537, TA98 and TA100) and with one strain with an AT base pair at the primary reversion site (e.g. E. coli WP2 or S. typhimurium TA102). The latter strain is needed in order to detect certain oxidising mutagens, cross-linking agents and hydrazines. This study has been performed with the four strains TA1535, TA1538 (instead of TA1537, recommended by the guideline), TA98 and TA100, but not with the additional AT base pair containing strain. Neither 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) nor 1,1,1-trichloro-2,2,2-trifluoroethane (target chemical) is an oxidising substance or is a hydrazine. In addition, based on their chemical structure, both chemicals are not expected to have cross-link capabilities. Thus the lack of testing with the additional strain does not significantly restrict the reliability, relevance and adequacy of this study.

The bacterial mutagenicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the Ames 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).

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
However some indication of toxicity seen in trial II with strain TA98 (see table)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
The test item 1,1,2-trichloro-1,2,2-trifluoroethane was non-mutagenic in the 4 strains of Salmonella typhimurium (TA1535, TA1537, TA98, and TA100) tested with and without metabolic activation.

Remark of the registrant:
According to OECD TG 471 the test should be performed with (at least) five strains: i.e. with four S. typhimurium strains with GC base pairs at the primary reversion site (e.g. TA1535, TA1537, TA98 and TA100) and with one strain with an AT base pair at the primary reversion site (e.g. E. coli WP2 or S. typhimurium TA102). The latter strain is needed in order to detect certain oxidising mutagens, cross-linking agents and hydrazines. This study has been performed with the four strains TA1535, TA1537, TA98 and TA100, but not with the additional AT base pair containing strain. Neither 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) nor 1,1,1-trichloro-2,2,2-trifluoroethane (target chemical) is an oxidising substance or is a hydrazine. In addition, based on their chemical structure, both chemicals are not expected to have cross-link capabilities. Thus the lack of testing with the additional strain does not significantly restrict the reliability, relevance and adequacy of this study.

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 item 1,1,2-trichloro-1,2,2-trifluoroethane was non-mutagenic in the 4 strains of Salmonella typhimurium (TA1535, TA1537, TA98, and TA100) tested with and without metabolic activation.

 

Remark of the registrant:

According to OECD TG 471 the test should be performed with (at least) five strains: i.e. with four S. typhimurium strains with GC base pairs at the primary reversion site (e.g. TA1535, TA1537, TA98 and TA100) and with one strain with an AT base pair at the primary reversion site (e.g. E. coli WP2 or S. typhimurium TA102). The latter strain is needed in order to detect certain oxidising mutagens, cross-linking agents and hydrazines. This study has been performed with the four strains TA1535, TA1537, TA98 and TA100, but not with the additional AT base pair containing strain. Neither 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) nor 1,1,1-trichloro-2,2,2-trifluoroethane (target chemical) is an oxidising substance or is a hydrazine. In addition, based on their chemical structure, both chemicals are not expected to have cross-link capabilities. Thus the lack of testing with the additional strain does not significantly restrict the reliability, relevance and adequacy of this study.

 

The bacterial mutagenicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the Ames 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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test substance 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) demonstrated negative results in several in vitro bacterial gene mutation tests (Ames) with and without metabolic activation.

The bacterial mutagenicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the Ames 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 considered to have negative results in the Ames test.

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


Short description of key information:
several negative Ames tests on 1,1,2-trichloro-1,2,2-trifluoroethane with and without metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance demonstrated (via read-across) negative results in several in vitro bacterial gene mutation tests (Ames). As a result the substance does not meet the criteria for classification (mutagenic substances) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 4.2.2.

The substance demonstrated (via read-across) negative results in several in vitro bacterial gene mutation tests (Ames). As a result the substance does not meet the criteria for classification (germ cell mutagenicity) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.5.2.