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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

Referenceopen allclose all

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.

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.