Sodium acrylate

Endpoint summary

Description of key information

The test substance was virtually nontoxic after a single ingestion in a study similar to OECD TG 401.
Oral: LD50 > 5000 mg/kg bw (Wistar rat)

No mortality was observed in an inhalation hazard test similar to OECD TG 403.

Based on data from the structural analogue acrylic acid, the test substance is not toxic after short-term skin contact.

Dermal: LD50 > 2000 mg/kg bw (rabbit)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Sep - 16 Oct 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF Test
- Principle of test: In principle, the methods described in OECD Guideline 401 were used.
- Short description of test conditions: 2 and 5 rats per dose respectively were treated by gavage with preparations of the test substance in 0.5 % CMC.
- Parameters analysed / observed: Group-wise documentation of clinical signs was performed over the 7-day (2000 and 4000 mg/kg bw) and 14-day study period (5000 mg/kg bw), respectively. Body weight was determined before the start of the study, as it was needed for determination of dose, and at test termination. The clinical signs and findings were reported in summary form.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier): Dr. Nestler (manufacturer)
- Lot/batch number of test material: not specified
- Purity: approx. 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: cool, dry, protected from light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: stable for 3 month

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Mean weight at study initiation: 191 g (males); 190 g (females)


ENVIRONMENTAL CONDITIONS: no details reported

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: aqueous suspension in 0.5 % CMC

MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/animal

Doses:

2000, 4000 and 5000 mg/kg bw

No. of animals per sex per dose:

- 2 animals per sex at 2000, and 4000 mg/kg bw
- 5 animals per sex at 5000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days (2000 and 4000 mg/kg bw) and 14 days (5000 mg/kg bw)
- Frequency of observations and weighing: Body weight determination of groups was performed at test start and termination. Lethality and clinical signs of toxicity were observed daily with the exception of weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no statistics were performed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred at any dose level.

Clinical signs:

other: No clinical signs of toxicity were observed at any dose level.

Gross pathology:

At necropsy of survivors, no gross-pathological abnormalities were detected.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1961

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

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 403 (1981). This test (also called inhalation hazard test) was performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C and 1025.2 hPa).
- Short description of test conditions:Several groups of 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for different time periods. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, and the amount of air used during the exposure.
- Parameters analysed / observed: Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance.

GLP compliance:

no

Test type:

other:

Limit test:

yes

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:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 135 g (mean)

ENVIRONMENTAL CONDITIONS: no details reported

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

approx. 0.025 mg/L

No. of animals per sex per dose:

6

Control animals:

no

Statistics:

no

Sex:

male/female

Exp. duration:

8 h

Remarks on result:

not determinable

Remarks:

No dust formation was reported during generation of the test atmosphere. Due to the solid nature and low vapour pressure of the test substance, it can be expected that no test substance vapours were generated.

Mortality:

No mortalities occurred.

Clinical signs:

other: The animals did not show any clinical signs of toxicity during or after exposure.

Body weight:

Body weights increased slightly within the 7-day study period up to a mean of 142 g.

Gross pathology:

At necropsy no abnormalities were observed.

No mortalities after 8-hour exposure to an atmosphere enriched with the test substance at 20°C. No dust formation was reported during generation of the test atmosphere. Due to the solid nature and low vapour pressure of the test substance, it can be expected that no test substance vapours were generated.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

08. Feb. - 22. Feb. 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: U.S. EPA Health Effects Test Guidelines, OCSPP 870.1200

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Composition: 20% acrylic acid Lot # 0104111S09
80% deionized water
Physical description: Clear colorless liquid
Solubility: Soluble in water.
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: January 4, 2012

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Robinson Services, Inc.
- Age at study initiation: 13 weeks
- Weight at study initiation: 1937 - 2221 g (males), 1814 -2176 g (females)
- Fasting period before study:
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Rabbit Chow #5326
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 22-38 %
- Air changes (per hr): 10 - 14
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Two thousand mg/kg of body weight of a 20% aqueous dilution of the test substance in distilled water (v/v) was applied evenly over a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface) and covered with a 4-inch x 8-inch, 6-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance. The rabbits were then returned to their designated cages. The day of application was considered Day 0 of the study. After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed of any residual test substance.

Duration of exposure:

24 hours

Doses:

2000 mg/kg of body weight of a 20 % aqueous dilution of th etest substance in distilled water

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality, signs of gross toxicity, and behavioral changes during the
first several hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous
membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. Individual body weights of the animals were recorded prior to test substance application
(initial) and again on Days 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Other than the dermal irritation, discoloration, fissuring and/or mechanical damage noted at the dose site of all animals throughout the 14-day observation period, there were no other clinical findings recorded for any animal over the course of the observ

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Other findings:

none reported

Table 1: Results

Animal No.	Sex	Body weight (g)			Dose^1
		Initial	Day 7	Day 14	mL
3801	M	1955	2124	2296	19.2
3802	M	2104	2288	2404	20.7
3802	M	2221	2287	2409	21.8
3804	M	1937	2071	2142	19.0
3805	M	2008	2042	2189	19.7
3806	F	2176	2344	2513	21.4
3807	F	2007	2167	2389	19.7
3808	F	2009	2064	2218	19.7
3809	F	1814	1946	2092	17.8
3810	F	2046	2086	2286	20.1

¹The test substance was applied as a 20% v/v mixture in distilled water. Specific Gravity - .1.017 g/mL

 

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Oral exposure route:

In an acute toxicity study conducted by BASF (1986), groups of 2 and 5 rats per dose respectively were administered doses of 2000, 4000, and 5000 mg/kg bw of the test substance by gavage and observed over a time period of 7 days for lethality and clinical signs of intoxication. The mortality rate was 0/2, 0/2, and 0/5 at 2000, 4000, and 5000 mg/kg bw, respectively. Thus, the LD50 was greater than 5000 mg/kg bw. No clinical signs of toxicity were observed at any dose level and no gross-pathological abnormalities were detected at necropsy of survivors. The mean body weight of groups increased at a normal rate during the observation period.

In two supporting studies, LD50 values of approx. 7000 and greater than 4000 mg/kg bw in rats were determined, respectively (BASF 1961, 1956).

 

Inhalation exposure route:

Concerning the acute inhalation toxicity of the test substance, an Inhalation Hazard Test was performed in rats according to an internal test method (BASF, 1961). Several groups of 3 rats per sex were exposed sequentially to the test substance by bubbling 200 L air/h through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for different time periods. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, and the amount of air used during the exposure (approx. 0.025 mg/L). Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance. No mortalities or clinical signs were observed during and after the 8-hour exposure to an atmosphere enriched with the test substance at 20°C. However, no dust formation was reported during generation of the test atmosphere. Due to the solid nature and low vapour pressure of the test substance, it can be expected that no test substance vapours were generated. Since the test substance has a very low vapour pressure and is not expected to cause considerable dust formation, no relevant exposure by the inhalation route is to be expected.

 

Dermal exposure route:

There are no data available concerning the acute toxicity of the test substance by the dermal exposure route. Therefore, the evaluation of the endpoint acute dermal toxicity is based on a weight of evidence approach using the toxicological data of the structural analogue acrylic acid (CAS 79-10-7) (for WoE information, see chapter 13.2).

An acute dermal toxicity test (BAMM, 2011) was conducted with rabbits to provide information on the potential health hazards from short term exposure to acrylic acid at non-corrosive concentrations via the dermal route. Acrylic Acid was tested as a preparation of 20% Acrylic Acid in water to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the acrylic acid is greater than 2000 mg/kg of body weight in male and female rabbits. All animals survived exposure to 2000 mg/kg acrylic acid and gained body weight during the study. Dermal irritation, discoloration, fissuring, and/or mechanical damage were noted at the dose site of all animals throughout the 14 -day observation period. There were no other findings recorded for any animal over the course of the observation period, also necropsy did not show gross abnormalities.

Taking all the presented data into consideration, the test substance was concluded to be virtually nontoxic after a single ingestion and after short-term skin contact. Due to its extremely low vapour pressure and negligible dust formation potential, exposure by the inhalation route is not expected.

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. As a result, the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.