Sodium acrylate

Endpoint summary

Description of key information

The test substance was not irritating to the skin and eyes in a study using an internal BASF method, respectively.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

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

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.

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

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

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

 

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

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

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

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.

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

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

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

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

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.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

The test substance (no data on purity) was tested using an internal method (BASF test) by applying aqueous test substance solutions for 1, 5 or 15 minutes (50%) as well as for 20 hours (30 and 50%, respectively) to the rabbit skin under occlusive conditions. Irritation scores were read 24, 48, and 72 hours and 8 days after application. Mean scores (24-48-72 hrs) after occlusive exposure for 20 hrs were for erythema 0.50, 0.67, 0, and 0, and for edema 0, 0, 0, and 0. All skin reactions were fully reversible within the study period of 8 days (BASF, 1961). Based on the presented test results, the test substance has no skin irritating properties.

 

Eye irritation:

An eye irritation study in White Vienna rabbits was conducted according to an internal study protocol. 50 mg of the undiluted test substance (no data on purity) were instilled into the eye of 2 rabbits. The adjacent eyes of the same animals were treated with talcum powder and served as control. The eyes were not washed out as recommended by OECD TG 405. Eye reactions were read after 1, 24, 48 and 72 hours. No eye reactions indicative of irritation were observed at any reading. Thus, the study was discontinued after 48 hrs (BASF, 1961). Under the conditions of the study, the test substance was not irritating to the eyes of rabbits.

 

Respiratory irritation:

There are no experimental indications for a potential of the test substance to cause respiratory irritation. Due to the substance’s low vapour pressure, and since the solid test substance was not irritating to the mucosa in an eye irritation study, irritation of the respiratory tract upon inhalation of vapours or dust particles is not to be expected. There are no human data available concerning the potential for respiratory irritation of the test substance.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. In both of the available studies for skin and eye irritation, the scores for the treated tissues indicate that the test substance is a non-irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.