Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 206-564-6 | CAS number: 354-58-5
Endpoint summary
Administrative data
Description of key information
Skin Sensitization:
Non sensitizing to the skin - based on a read across from the test substance 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) which demonstrated negative results in two in vivo Guinea Pig Maximisation Tests. (Hunter 1985 and Malcewski 1985)
Respiratory Sensitization:
no data available
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of 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:
- 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
- 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.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 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:
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 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1985-06-11 to 1985-10-28
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- 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: test group. Dose level: undiluted. 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:
- test chemical
- Dose level:
- undiluted
- 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: test group. Dose level: undiluted. 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:
- test chemical
- Dose level:
- undiluted
- 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: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 5.0. 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: 4/4, mean edema score: 2.4/4
- 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: 4/4, mean edema score: 2.4/4.
- 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: 4/4, mean edema score: 2.4/4
- 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: 4/4, mean edema score: 2.4/4.
- 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: 4/4, mean edema score: 2.4/4
- 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: 4/4, mean edema score: 2.4/4.
- 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.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 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:
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 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. 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.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) demonstrated negative results in several in vivo Guinea Pig Maximisation Tests.
The skin sensitisation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from in vivo Guinea Pig Maximisation Tests 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.
In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2, the available data for skin sensitisation potential is considered to be adequate for the purposes of risk assessment, and classification and labelling, based on the weight-of-evidence.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance demonstrated negative results in several in several in vivo Guinea Pig Maximisation Tests. As a result the substance does not meet the criteria for classification (sensitisation by skin contact) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.7.2.
The substance demonstrated negative results in several in several in vivo Guinea Pig Maximisation Tests. As a result the substance does not meet the criteria for classification (skin sensitisers) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.4.2.2.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
