Reaction mass of toluene and 2-vinyl-1,3-dioxolane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11/10/2005 to 25/10/2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to international guidelines but not under GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-vinyl-1,3-dioxolane

EC Number:

223-626-8

EC Name:

2-vinyl-1,3-dioxolane

Cas Number:

3984-22-3

Molecular formula:

C5H8O2

IUPAC Name:

2-vinyl-1,3-dioxolane

Constituent 2

Reference substance name:

Toluene

EC Number:

203-625-9

EC Name:

Toluene

Cas Number:

108-88-3

Molecular formula:

C7H8

IUPAC Name:

toluene

Test material form:

liquid

Details on test material:

Batch No.: LF-364-162
Name of test material (as cited in study report): 2-VINYL-1,3-DIOXOLANE
Physical state: colourless liquid
Storage conditions: ambient temperature, protected from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier, Le Genest St Isle, France
- Weight at study initiation: males between 228 g and 246 g, and females between 212 g and 225 g
- Acclimatisation period: at least 5 days
- Diet: rats-mice maintenance pelleted diet

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 and 22
- Humidity (%): between 47 and 54

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: Dimethylsulfoxide

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): test group: 2.01 mL/kg body weight (corresponding at dose 50 mg/kg body weight)

VEHICLE
- Amount(s) applied (volume or weight with unit): control group: 2 mL/kg body weight of distilled water

Duration of exposure:

24h

Doses:

50 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Remarks:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systemic examinations were carried out to identify behavioral or toxic effects on physiological functions at 1, 3, 5h and day 1 to 14 after administration of the product. Animals were weighed on D0 before application of the product, D2, D7, and D14.
- Necropsy of survivors performed: yes, performed on D14 for the macroscopic examination of the following organs: oesopahgus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, testicles, ovaries, uterus, adrenals, pancreas and treatment area (skin).

Statistics:

no data

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 50 mg/kg bw

Mortality:

No mortality was observed

Clinical signs:

No systemic clinical signs were noted.

Body weight:

Bodyweights were normal through out the study in both treated and control groups.

Gross pathology:

No significant toxic effects.

Other findings:

No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of test item REACTION MASS OF TOLUENE AND 2-VINYL-1,3-DIOXOLANE is higher than 50 mg/kg body weight. Therefore it should not be classified according to CLP Regulation (EC) No 1272/2008.

Executive summary:

An acute dermal toxicity study was conducted on REACTION MASS OF TOLUENE AND 2-VINYL-1,3-DIOXOLANE (limit test) according to OECD Guideline 402. Two groups of 5 Sprague-Dawley rats/sex were used: one control group exposed to distilled water and one test group. The test substance was applied to the skin by topical application for 24 h, under semi-occlusive conditions, at 50 mg/kg bw, with a volume of 2.01 mL/kg bw. After exposure, exposure area was washed with distilled water.

Animals were observed every day for systemic clinical signs and mortalities for 14 days. The animals were weighed on D0, D2, D7 and D14.

Therefore, the LD50 of REACTION MASS OF TOLUENE AND 2-VINYL-1,3-DIOXOLANE is higher than 50 mg/kg bw by dermal route in the rat, and REACTION MASS OF TOLUENE AND 2-VINYL-1,3-DIOXOLANE should not be classified according to CLP Regulation (EC) No 1272/2008.