Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 25, 1980 to October 28, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the equivalent of standard guidelines.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Method: 40 CFR Part 163.81-2 (Environmental Protection Agency, Pesticide Programs. Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals. Acute Dermal Toxicity Study)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
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
Details on test material:
Name of test material (as cited in study report): SN-2196, C-171, JAB 318-80
Physical state: Viscous, clear liquid
Density: 1.1788 g/mL
Storage condition of test material: Stored at room temperature

Test animals

Species:
rabbit
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: Males: 2.2-2.8 kg and females: 2.5-2.9 kg
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): Municipal water, ad libitum
- Acclimation period: 19 d


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-66 °F
- Photoperiod (h dark / h light): 12 h dark / 12 h light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- % coverage: 10 % of the body surface area
- Type of wrap if used: Test material applied directly, covered by gauze and then wrapped with an impervious plastic sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test site wiped free of excess test material
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.7 mL/kg
- Concentration (if solution): 2,000 mg/kg
Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
Six males and four females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: Animals were observed twice daily for viability check; pharmacological/toxicological signs were observed at 1, 2 and 4 h after dosing and daily thereafter for 14 d; weighed at pre-dose (at the time of clipping), day of dosing , days 7 and 14 or at terminal sacrifice
- Necropsy of survivors performed: Yes; surviving animals were killed by intravenous overdose of sodium pentobarbital
- Other examinations performed: Local irritation reactions were observed 30 min after removal of test material
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Mortality:
All animals survived throughout the study period
Clinical signs:
- Nasal and/or oral or ocular discharge were observed in several animals during the 14-d post-dose period
- Fecal staining of the abdomen was observed in one animal at 24 h
Body weight:
All animals showed body weight gain except one male and one female
Gross pathology:
Necropsy revealed abnormalities like small or pale spleen; red foci in adrenals; raised, yellow and hard seminal vesicles; tan lungs; stomach or small intestines extremely distended with gas.
Other findings:
- Decreased food consumption was observed in one animal

Local irritation reactions at application site:
- Well-defined to severe erythema with moderate or severe edema at 24 h
- Two animals exhibited eschar at the dosing site at terminal necropsy

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the acute dermal LD50 of C-171 in male/female rabbits was > 2,000 mg/kg bw. The discriminating dose is 2,000 mg/kg bw.
Executive summary:

A study was conducted to assess the acute dermal toxicity of C-171 in New Zealand White rabbits using the method equivalent or similar to OECD Guideline 402.

A group of 6 male and 4 female New Zealand White rabbits received a single dermal application of 2,000 mg/kg bw at a dose volume of 1.7 mL/kg to a shaved area of the back representing 10 % of the total body surface area. The application was occluded and exposure was for 24 h. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 days observation period.

No mortality occured at 2,000 mg/kg bw. All animals, except one male and one female, showed body weight gain during the study.

Clinical signs noted in several animals were nasal and/or oral or ocular discharge. Decreased food consumption and fecal staining of the abdomen were observed in one animal at 24 h. Well-defined to severe erythema with moderate or severe edema were observed at the application site at 24 h. Two animals exhibited eschar at the dosing site at terminal necropsy. Necropsy revealed abnormalities like small or pale spleen; red foci in adrenals; raised, yellow and hard seminal vesicles; tan lungs; stomach or small intestines extremely distended with gas.

 

In conclusion, under the conditions of the study, the acute dermal LD50 of C-171 in male/female rabbits was > 2,000 mg/kg bw. The discriminating dose is 2,000 mg/kg bw.