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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:
8 February 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Nature of substance: Solide

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
.1 ML
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Score:
0.11
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.08
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days

Any other information on results incl. tables

Animal

Sex

Observation period

Cornea

opacity

Iris

Redness

Chemosis

1

M

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

2

M

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

1

0
0

1

0

0

0

3

F

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

4

M

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

1

0

0

1

0

1

0

5

F

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

6

F

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

Not classified i.e.:

The substance did not, when applied to the eye of an animal, produce:

At least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 1 and/or

— iritis ≥ 1, and/or

— conjunctival redness ≥ 2 and/or

— conjunctival oedema (chemosis) ≥ 2

Calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based upon the results of this study, Phosphorous acid, cyclic neopentanetetrayl bis (2,6-di-tert-butyl-4-methylphenyl) ester is considered to be mildly irritating to rabbit eyes.