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Toxicological information

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:
From 14 Oct, 1980 to 28 Oct, 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 40 CFR Part 163.81-2 (Environmental Protection Agency, Pesticides Programs, Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals. Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(hydroxymethyl)-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate
EC Number:
222-540-8
EC Name:
2-(hydroxymethyl)-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate
Cas Number:
3524-68-3
Molecular formula:
C14H18O7
IUPAC Name:
3-(acryloyloxy)-2-[(acryloyloxy)methyl]-2-(hydroxymethyl)propyl acrylate
Constituent 2
Reference substance name:
2-Propenoic acid, reaction product with pentaerythritol
IUPAC Name:
2-Propenoic acid, reaction product with pentaerythritol
Constituent 3
Reference substance name:
2-Propenoic acid, reaction products with pentaerythritol
EC Number:
629-850-6
Cas Number:
1245638-61-2
Molecular formula:
Not available for this UVCB.
IUPAC Name:
2-Propenoic acid, reaction products with pentaerythritol
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): C171
- Physical state: Viscous clear liquid
- Analytical purity: Not mentioned in the report
- Expiration date of the lot/batch: 9/1/81

Test animals

Species:
other: Albino rabbits
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Penn Dutch Laboratory animals, Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: 2.2 to 2.8 kg (males), 2.5 to 2.9 kg (females)
- Housing: Individually housed
- Diet: Purina Rabbit Chow, ad libitum
- Water: Automatic watering system, ad libitum.Municipal water supply (Elizabethtown Water Co. )

ENVIRONMENTAL CONDITIONS
- Temperature: 60 to 66°F
- Photoperiod: 12 h light, 12 h dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day before dosing (approx 18 h prior to dosing), the hair of each rabbit was closely clipped from the trunk with an electric clipper, so as to expose at least 10% of the body surface area. Just prior to dosing, the skin of all of the animals was abraded longitudinally every 2 or 3 cm over the area of exposure, deep enough to penetrate the stratum corneum, but not so deep as to disturb the dermis or produce bleeding. The test substance was applied directly onto the exposed skin of the animal, and spread evenly over the entire area. A layer of 8-ply gauze was then wrapped around the animal to cover the application site. The animal was then wrapped in an impervious plastic sleeve, designed to contain the test substance without leakage or undue pressure. The sleeve was secured with masking tape and Elizabethan collars were placed on all animals. Following approx 24 h of exposure, the wrappings were removed and the test site wiped free of excess test substance. After 30 min, dermal observations were made.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (six males, four females)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Approx 1, 2, and 4 h after dosing and daily thereafter for 14 d.
- Necropsy of survivors performed: Gross post mortem examinations were performed on all animals which died or were found dead during the study. All animals surviving at termination of the observation period (Day 14) were killed by an intravenous overdose of sodium pentobarbital and examined grossly. All abnormalities were recorded hut no tissues were saved.
- Other examinations performed: Clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
No
Body weight:
Most animals gained weight during the 14 d after dosing. However, one male and one female exhibited weight losses.
Other findings:
All animals exhibited well-defined to severe erythema with moderate or severe edema at 24 h. Two animals exhihited eschar at the dosing site
at terminal necropsy. Several animals exhibited nasal and/or oral or ocular discharge during the 14 d post-dose period. A single animal exhibited decreased food consumption and fecal staining of the abdomen at 24 h only.

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP criteria not met
Conclusions:
Under the study conditions, the dermal LD50 of the test substance was determined to be >2,000 mg/kg bw in rabbits.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, PETIA in rabbits according to the EPA 40 CFR Part 163.81-2. A single dose of 2,000 mg/kg bw was administered at a dose volume of 1.7 mL/kg bw to ten rabbits (six males and four females). Following approximately 24 h of exposure, the wrappings were removed and the test site wiped free of excess test substance. After 30 min, dermal observations were made. No mortality occurred and most animals gained weight in the 14 d period after dosing although one male and one female exhibited weight loss. All animals showed well-defined to severe erythema with moderate or severe edema at 24 h. In two animals, eschar was seen at the dosing site at terminal necropsy. Several animals had nasal and/or oral or ocular discharge during the 14 d post-dose period. A single animal exhibited decreased food consumption and fecal staining of the abdomen at 24 h only. Under the study conditions, the dermal LD50 of the test substance was determined to be >2,000 mg/kg bw in rabbits (Auletta, 1980).