Sodium acrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Feb - 17 Feb 1961

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:

1961

Report date:

1961

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: BASF test using an internal method, as the study was conducted before the implementation of GLP and OECD guideline 405 (1981).
- Short description of test conditions: White Vienna rabbits were used. Approx. 50 mg of the test substance were applied to the conjunctival sac of one eye in 2 animals. The talcum powder-treated adjacent eye served as control. The eyes were not washed out after 24 hours as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage, which would probably be less severe if it had been washed out after 1 day.
- Parameters analysed / observed: The animals were observed several times on the day of treatment and up to 8 days afterwards. Findings were recorded on working days. The report usually describes findings after 1 and 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium acrylate

EC Number:

231-209-7

EC Name:

Sodium acrylate

Cas Number:

7446-81-3

Molecular formula:

C3H3NaO2

IUPAC Name:

sodium acrylate

Details on test material:

- Name of test material (as cited in study report): Sodium acrylate
- Physical state: solid
- Analytical purity: no data

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: not specified
- Purity: not specified

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:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg of the test substance were applied to the conjunctival sac of the eye
- Concentration (if solution): 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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1: 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:

GHS criteria not met