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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloro-1-fluoro-4-(trifluoromethyl)benzene
EC Number:
616-586-1
Cas Number:
78068-85-6
Molecular formula:
C7H3ClF4
IUPAC Name:
2-chloro-1-fluoro-4-(trifluoromethyl)benzene
impurity 1
Chemical structure
Reference substance name:
1-Chloro-2-fluoro-4-(trifluoromethyl)benzene
Cas Number:
32137-20-5
Molecular formula:
C7H3ClF4
IUPAC Name:
1-Chloro-2-fluoro-4-(trifluoromethyl)benzene
Test material form:
liquid
Specific details on test material used for the study:
Purity: 89.5 % [a/a]

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Origin of animals: Charles River Deutschland GmbH, 88353 Kißlegg
Body weight at start of study: 3.89-3.98 kg
Individual housing
Humidity: 50+/- 20 %
Room temperatur:20+/-3 °C
Photoperiod: 12/12 h light/dark
Feeding: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g/d)
Acclimatization: 1 week under study conditions

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml per eye
Duration of treatment / exposure:
Administered once
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before the start of the experiment the eyes of all animals were examined under UV-light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution.
Only animals without ocular abnormalities were used for this study.
0.1 ml of the test substance was administered once to the conjunctival sac of the left eye of 3 rabbits.
The untreated eye served in each case as a control.
The eyes were examined 1, 24, 48 and 72 hours after application of the testing substance. At 24 h and 72 h the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% of fluorescein-sodium solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study 3-chloro-4-fluorobenzotrifluoride is not irritating to eye.