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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:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α,α-trifluorotoluene
EC Number:
202-635-0
EC Name:
α,α,α-trifluorotoluene
Cas Number:
98-08-8
Molecular formula:
C7H5F3
IUPAC Name:
α,α,α-trifluorotoluene

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: 2.6 - 3.1 kg

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: washed with physiological saline
- Time after start of exposure: 24 hrs after exposure

SCORING SYSTEM:
The effects were evaluated in accordance with the Draize scheme, 1, 24, 48 and 72 hours after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was evaluated as not irritating to the eye.
Executive summary:

The primary irritation potential of the test item was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits in an OECD 405 study. The treated eyes were rinsed gently with physiological saline solution approximately 24 hours after administration. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.