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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Pouvoir irritant des principaux solvants chlorés aliphatiques sur la peau et les muqueuses oculaires du lapin
Author:
Duprat P, Delsaut L, Gradiski D
Year:
1976
Bibliographic source:
Eur J Toxicol. 1976, 9(3) 171-7

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test item 1,1,2-trichloro-1,2,2-trifluoroethane was applied into the eye of six New-Zealand rabbits. After an unknown exposure time, the severity of irritation/corrosion was quantified. Classification was based on the method of Kay and Calandra. Histological examination of the treatment site was performed.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
1,1,2-trichlorotrifluoroethane
EC Number:
200-936-1
EC Name:
1,1,2-trichlorotrifluoroethane
Cas Number:
76-13-1
IUPAC Name:
1,1,2-trichloro-1,2,2-trifluoroethane
Details on test material:
- Name of test material (as cited in study report): "trichloro trifluoro-1,1,2-ethane", "trichloro 1,1,2-trifluoro-ethane"
- 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
- Analytical purity: > 99%
- Supplier: "Flucka"

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4-3.0 kg
- Sex: female

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
6 animals per test item were used
Details on study design:
SCORING SYSTEM: According to the method described by Kay and Calandra (Kay JH, Calandra JC, Interpretation of eye irritation tests, J Soc Cosmetic Chem. 1962, 13: 281-289)

TOOL USED TO ASSESS SCORE: microscope / fluorescein

Results and discussion

In vivo

Results
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Kay JH, Calandra JC, J Soc Cosmetic Chem. 1962, 13: 281-9
Conclusions:
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 the 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 the eyes.
Executive summary:

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.