Glycerol, propoxylated, esters with acrylic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Mar. 16, 1983 to Mar. 30, 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: 40 CFR Part 163.81-2 (EPA Pesticides Programs, proposed guidelines for registering pesticides in the U.S.; hazard evaluation: humans and domestic animals, acute dermal toxicity study)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol, propoxylated, esters with acrylic acid

EC Number:

500-114-5

EC Name:

Glycerol, propoxylated, esters with acrylic acid

Cas Number:

52408-84-1

Molecular formula:

(C3H6O)m(C3H6O)n(C3H6O)oC12H14O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.',.alpha.''-1,2,3- propanetriyltris[.omega.-[(1-oxo-2-propenyl)oxy]]-

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton-Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: Males: 2.5 to 2.9 kg, Females: 2.7 to 3.4 kg
- Housing: Individually housed; suspended, stainless steel cages
- Diet: Purina Lab Rabbit Chow HF (#5326), ad libitum
- Water: Automatic watering system, Municipal water supply (Elizabethtown Water Co.), ad libitum
- Acclimation period: 36 d

ENVIRONMENTAL CONDITIONS
- Temperature: 15.55 - 21.11 °C
- Photoperiod: 12 h dark / 12 h light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: On the day prior to dosing (approximately 18 h), the hair of each rabbit was closely clipped from the trunk (dorsal and ventral surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 20% of the body surface area. Just prior to dosing, using a hypodermic needle with the point filed off, the skin of all the animals was abraded longitudinally every 2 or 3 centimeters over the area of exposure. Abrasions were deep enough to penetrate the stratum corneum, but not so deep as to disturb the dermis or produce bleeding.
- Type of wrap: A layer of 8-ply gauze was wrapped around the animal to cover the application site. The animal was then wrapped in an impervious plastic sleeve, designed to contain the test material without leakage or undue pressure. The sleeve was secured with masking tape and Elizabethan collars were placed on all animals.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 1.8 mL/kg bw (2000 mg/kg bw)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Viability check: Twice daily
- Observations of pharmacologic and toxicologic signs: Approximately 1, 2, and 4 h after dosing and daily thereafter for 14 d.
- Body weights: Pre-test, at the time of clipping (weights used for calculation of doses); pre-dose (just prior to dosing); Days 7 and 14
- Evaluation of skin irritation: Observations for erythema and edema or other evidence of irritation or injury were made approximately 30 min. after re moval of the occlusive wrapping. Draize scoring scale was used (Draize, 1959).
- Necropsy of survivors performed: Yes, all animals surviving at termination of the observation period (Day 14) were killed by an intravenous overdose of sodium pentobarbital and examined grossly.

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:

None

Clinical signs:

other: All ten animals exhibited decreased food consumption on day 2 and a few continued to exhibit this finding on day 3. One male was noted to have a swollen scrotum from day 2 through 5. Other signs (nasal or ocular discharge, fecal staining) were noted spora

Gross pathology:

Except for the presence of necrosis and eschar at the dose site in five animals, observations made at necropsy were similar to those seen in control animals in the testing laboratory or were considered to represent normal physiological variations.

Other findings:

- Dermal observations: Moderate to severe erythema accompanied by moderate edema was exhibited in seven of the ten animals 24 h after dosing. One male and two females exhibited well-defined erythema and slight or severe edema. Small areas of necrosis were seen in most animals from day 2, with subsequent eschar formation and exfoliation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met