Acrylic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08. Feb. - 22. Feb. 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

Acrylic acid

EC Number:

201-177-9

EC Name:

Acrylic acid

Cas Number:

79-10-7

Molecular formula:

C3H4O2

IUPAC Name:

prop-2-enoic acid

Test material form:

liquid

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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met