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Toxicological information

Acute Toxicity: dermal

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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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.