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Acute Toxicity: dermal

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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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 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 observation period.
Body weight:
Increased as expected for all animals over the course of the study.
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

Animal No.

Sex

Body weight (g)

Dose1

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
Conclusions:
LD50 of test item is greater than 2,000 mg/kg of body weight of a preparation of 20% Acrylic Acid in Water.
Executive summary:

An acute dermal toxicity test 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. This study was conducted to confirm the results from earlier research which was conducted under non GLP conditions. 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 2,000 mg/kg of body weight in male and female rabbits. All animals survived exposure to 2,000 mg/kg acrylic acid and gained body weight during the study. Dermal irritation, discoloration, fissuring, and/or mechanical damage was 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.