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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: EEC Directive B.5. 'Acute toxicity eye irritation' of Directive 84/449/EEC
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
5-Fluoro-2-nitrobenzoic acid methyl ester
EC Number:
609-664-1
Cas Number:
393-85-1
Molecular formula:
C8H6FNO4
IUPAC Name:
5-Fluoro-2-nitrobenzoic acid methyl ester
Test material form:
other: yellow liquid
Details on test material:
purity: 96.9+/- 0.2 %, storage: Darkness at room temperature under the fume cupboard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Weight of the animals: 3.0-3.4 kg, age of the animals: about 3-5 months, animal housing: In fully air-conditioned rooms, seperate cages (arranged in a battery), room temperature: 20+/-3 °C, relative humidity: 50+/- 20 %, lighting time: 12 hours per day, diet: Altromin 2123 maintencance-rabbits (Altromin GmBH, Lage/Lippe ), ad libitum and hay (approx. 15 g per day), strain: chbb:NZW (SPF), source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberbach , ID: numbered ear tags

Test system

Controls:
other: The untreated eye served in each case as a control
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 animals
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 % fluorecein-sodium solution. Only animals without occular abnormalities were used for this study.0.1 ml of the testing substance was applied 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 adn 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

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h;48;72h
Score:
0.1
Max. score:
0.3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The testing of 5-Fluoro-2-nitrobenzoic acid methyl ester for primary eye irritation in the rabbit showed that the substance is not irritating to the eye.