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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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Identity FAT 65004/F TE
Batch 15060201 (China)
Purity determined in this study
Appearance
Smell
yellowish powder, solid at 20°C
neutral
pH-Value pH-value of a soln. of 2% (w/w) = 6.90
Expiration date August 25th, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
A cream coloured liquid labelled FAT 65 004

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The substance was tested on 6 rabbits (3 male and 3 female) of the Russian breed (obtained from the breeder, weighing 1.4 to 1.7 kg) which were kept separately in metal cages (overall dimensions 47x32x34cm) and fed with standard diet of Nafag and drinking water ad libitum. The animals were acclimatized to the enviroment in our laboratories. They were kept at a constant temperature of 18±1 C° and relative humidity of 55±5%, with 14 hours light/day. Only rabbits showing normal ophthalmic findings
were included in the test.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
Six rabbits (3 male and 3 female)
Details on study design:
The technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO) was followed.

Amounts of 0.1ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe. After application the eyelids were held open for a few seconds. The right eye was left untreated and served as a control.
The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.
The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3 and 6 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Results and discussion

In vitro

Other effects / acceptance of results:

None

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 65 004 is not an eye irritant in the albino rabbit.
Executive summary:

The technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO) was followed to assess the eye irritation potential of test substance FAT 65004/A when exposed to rabbit eye.

Amounts of 0.1ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe. After application the eyelids were held open for a few seconds. The right eye was left untreated and served as a control.

The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.

The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3 and 6 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Minimal transient conjunctival reaction (mean reaction score: 2 after 1 and 6 hours) was noted in one single animal.

FAT 65 004/A was found to be practically non irritant when applied to the rabbit eye mucosa.