Propylene carbonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

purity not reported

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propylene carbonate

EC Number:

203-572-1

EC Name:

Propylene carbonate

Cas Number:

108-32-7

Molecular formula:

C4H6O3

IUPAC Name:

4-methyl-1,3-dioxolan-2-one

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-57-2
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-253
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data
- Other: specific gravity=1.203ml/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: Sgarlat's Rabbitry, Harvey's Lake, pennsylvania
- Age at study initiation: adult
- Weight at study initiation: 2.190-2.675 kg
- Fasting period before study: no
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory
Resources, National Research Council
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light


IN-LIFE DATES: From: 1985-08-29 To:1985-09-12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk (clipped free of fur)
- % coverage: min.10%
- Type of wrap if used: rubber dam and an ace bandage


REMOVAL OF TEST SUBSTANCE: no washing



TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Ten ( 5 females and 5 males)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 2h and 4h after the 24 h of exposure and twice daily for 14 days. Weighing: d0, d7 and d14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Mortality:

None of the animals died during the 14 days study.

Clinical signs:

other: Slight erythema: 10/10 animals, at 2 , 4 hours and Day 2 after the 24 hour period of exposure. On Day 3, all animals appeared normal.

Gross pathology:

No signs observed

Applicant's summary and conclusion

Conclusions:

Based upon the observations made in the Acute Dermal Toxicity Test in Rabbits, the estimated acute dermal LD50 for the test substance was determined to be greater than 2000 mg/kg bw.