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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment. No Purity of test substance available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO)
Principles of method if other than guideline:
In a Draize Test 0.1 g of the test substance was instilled into the conjunctival sac of the left eye of 3 male and 3 female animals. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]
EC Number:
265-512-0
EC Name:
Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]
Cas Number:
65140-91-2
Molecular formula:
C17 H29 O4 P. 1/2Ca
IUPAC Name:
calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian Breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: single housing in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food, ad libitum
- Only rabbits showing normal ophthalmic findings were included in the test.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye served as a control.
Amount / concentration applied:
0.1 g test substance
Duration of treatment / exposure:
3 animals: washing after 30 seconds
3 animals: single treatment without washing
Observation period (in vivo):
7 days (scoring after 1, 2, 3, 4, and 7 days)
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.

SCORING SYSTEM: Draize scheme

TOOL USED TO ASSESS SCORE:
The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritating effects were observed throughout the whole study both in rinsed and unrinsed eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In an eye irritation study and amount of 0.1 g of the test article was instilled into the left conjunctival sac of three male and three female rabbits. After application the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment, the other tree remained unwashed. The ocular reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. No irritation reactions were evident, all scores recorded at all time points for all animals were zero. Therefore, based on the results of this study, the test article is considered to be not irritating to the eye of rabbits.

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