Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Feb 1961 - 17 Feb 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets basic scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Principles of method if other than guideline:
BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium acrylate
- Physical state: solid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.67 kg (mean)


ENVIRONMENTAL CONDITIONS
no details reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye was treated with one drop of talcum powder and served as a control.
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
48 hrs
Observation period (in vivo):
48 hrs (the study was terminated after 48 hrs due to lack of signs of irritation)
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48 hrs
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48 hrs
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Mean scores after 24, 48 and 72 h:

 

Scores

24 h

48 h

72 h

mean

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Conjunctivae

0

0

0

0

-*

-*

0

0

Cornea

0

0

0

0

-*

-*

0

0

Chemosis

0

0

0

0

-*

-*

0

0

Iritis

0

0

0

0

-*

-*

0

0

Discharge

0

0

0

0

-*

-*

0

0

* The study was discontinued after 48 hrs.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU