Isooctyl acrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No description of GLP compliance is available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C-236

IUPAC Name:

C-236

Details on test material:

- Name of test material (as cited in study report: C-236
- Substance type: Clear, colorless liquid with nauseating odor
- Physical state: Liquid
- Storage condition of test material: Room Temperature
- Other: Density 0.8874 g/ml

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc. Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: Males 2.2 to 2.4 kg; Females 2.4 to 2.8 kg
- Fasting period before study: No
- Housing:- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60 -71 F
- Humidity (%): monitored
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Hair was clipped with electric clippers to expose at least 20% of body surface area. Exposed skin of all animals was scraped longitudinally every 2 to 3 centimeters. Abrasions were deep enough to penetrate the stratum corneum, but not deep enough to penetrate the dermis or produce bleeding.
- % coverage:
- Type of wrap if used: Material was applied directly onto the exposed skin, covered with 8-ply gauze and covered with an impervious plastic sleeve.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following 24 hours of exposure, the test site was wiped free of excess test material.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg body weight
- Concentration (if solution): 2.3 ml/kg body weight
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no

Duration of exposure:

24 hours

Doses:

2.0 g/kg body weight

No. of animals per sex per dose:

5 animals/sex

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed 1, 2 and 4 hours after dosing and daily thereafter. Weighed pre-dose, day of dosing and day 7 and day 14
- 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

Remarks on result:

other: All animals survived the 2.0 g/kg dose level.

Mortality:

None

Clinical signs:

other: All animals exhibited well-defined or moderate to severe erythema with very slight to severe edema at 24 hours.

Gross pathology:

Desquamation occurred in all animals. One to four animals exhibited nasal and oral discharge, fecal staining, soft stool and food consumption decrease.

Other findings:

No exposure related effects were seen upon necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

Dermal LD50 exceeds 2000 mg/kg body weight

Executive summary:

A single dose of the test material at 2 grams/kg was administered to the clipped backs of ten New Zealand white rabbits (5 males and 5 females). The area was then covered with gauze and wrapped in an impervious sleeve for 24 hours. After 24 hours the sites were unwrapped and any excess material was wiped away. Animals were observed for 14 days post-dosing. There were no deaths or moribund animals during the observation period. Between days 7 and 14 all animals exhibited weight gain. All animals exhibited well-defined or moderate to severe erythema with very slight to severe edema at 24 hours. Clinical signs sporadically observed in some animals included nasal and oral discharge, fecal staining, soft stool, and food consumption decrease. There were no exposure-related effects noted on gross necropsy.