Sodium acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Feb - 23 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 404 (1981).
- Short description of test conditions: White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and 4 other animals for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance solved in aqua dest. (30 % for 20 h and 50 % for 1, 5, 15 min and 20 h) on a patch. After the application time of 1, 5, and 15 minutes, respectively, the skin was first washed with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %). The skin of the animals that had been treated with the test substance dermally for 20 hours, remained unwashed. In addition, skin tissue from the ear was tested by wrapping the ear with a cotton patch drenched in approx. 2 mL of the test compound. These results from the ear, however, were not taken into account for evaluation as they do not represent testing of the dorsal / lateral flank of the back.
- Parameters analysed / observed: The animals were observed for 8 days and skin reactions were recorded on working days. The report describes findings after 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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.77 kg (mean)

ENVIRONMENTAL CONDITIONS: no details reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no amount specified
- Concentration (if solution): 30 % (20 h exposure), 50 % (1, 5, 15 min, and 20 h exposure)

Duration of treatment / exposure:

1 min, 5 min, 15 min, and 20 h

Observation period:

48 - 72 hrs

Number of animals:

2 animals (1, 5, 15 min); 4 animals (20 h)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data

REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 h)
- Time after start of exposure: 1, 5, and 15 min, respectively

OBSERVATION TIME POINTS: after 24, 48, 72 hours; 8 days

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:

erythema score

Remarks:

20 hrs exp. (50 % aqueous)

Basis:

mean

Remarks:

2 animals

Time point:

24/48/72 h

Score:

0.59

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

20 hrs exp. (50 % aqueous)

Basis:

mean

Remarks:

2 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1: Mean erythema score after 24, 48 and 72 h

Exposure time	Concentration [%]	24 h		48 h		72 h		mean
		Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2
1 min	50	0	0	0	0	-*	-*	0	0
5 min	50	0	0	0	0	-*	-*	0	0
15 min	50	0	0	0	0	-*	-*	0	0
20 h	30	0	0	0	0	0	0	0	0
20 h	50	1**	1	0	1	-*	0	0.5	0.67

* The study was discontinued after 48 hrs.

** blotchy

 

Table 2: Mean edema score after 24, 48 and 72 h

Exposure time	Concentration [%]	24 h		48 h		72 h		mean
		Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2
1 min	50	0	0	0	0	-*	-*	0	0
5 min	50	0	0	0	0	-*	-*	0	0
15 min	50	0	0	0	0	-*	-*	0	0
20 h	30	0	0	0	0	0	0	0	0
20 h	50	0	0	0	0	-*	0	0	0

* The study was discontinued after 48 hrs.

 

Tabe 3: Findings at test termination 

Exposure time	Concentration [%]	Skin findings
		Animal 1	Animal 2
1 min	50	no skin findings	no skin findings
5 min	50	no skin findings	no skin findings
15 min	50	no skin findings	no skin findings
20 h	30	no skin findings	no skin findings
20 h	50	no skin findings	no skin findings

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met