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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:
From August 09 to September 21, 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(4R)-4-ethenyl-1,3-dioxolan-2-one; (4S)-4-ethenyl-1,3-dioxolan-2-one
EC Number:
700-261-7
Cas Number:
4427-96-7
Molecular formula:
C5H6O3
IUPAC Name:
(4R)-4-ethenyl-1,3-dioxolan-2-one; (4S)-4-ethenyl-1,3-dioxolan-2-one
Test material form:
liquid
Specific details on test material used for the study:
Batch No.: 10121040902
Purity: 99.92%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: SPF (Beijing) Biotechnology Co., Ltd
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: 56 days on arrival, in the range of 63~77 days at the commencement of each animal’s dosing.
- Weight at study initiation: The body weight ranges were 222~235 g at arrival, the body weight ranges were 248~260 g at grouping.
- Fasting period before study:
- Housing: Animals were raised in suspended, stainless steel cages (L32.0 cm ×W60.0 cm×H20.0 cm) on cage racks (L199.0 cm×W70.0 cm×H171.0 cm). Animals were housed individually during the exposure period and returned to group-caging after that.
- Historical data:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8-24.9℃ (target value was 20-25℃)
- Humidity (%): 47-70% (target value was 40%-70%)
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): A controlled light cycle was 12 hours light, 12 hours dark.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk of the test animals, about 40 cm2.
- % coverage: 100%
- Type of wrap if used: The gauze was placed over the treatment area and was wrapped with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by cotton wool soaked in water.
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
- 200 mg/kg bw
- 1000 mg/kg bw
- 2000 mg/kg bw
No. of animals per sex per dose:
Range-finding study: one female per dose
Main study: 2 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were performed once during the first 30 minutes and at 1, 2, 4 and 6 hours after application approximately and then once each day for 14 days.
General observations were made once daily for the animals not been administrated with the test item.
Careful observations and records of animal fur changes, eyes and mucosa, respiratory, circulatory, nervous system, particularly limb activity and behavior changes were made. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma.
Individual weights of animals were determined within 24 hours after arrival, at the end of adaption period, at grouping (the day before each animal's dosing day), on Day 0 (day of dosing), Day 7 and Day 14 or at death. Changes in weights were calculated and recorded.
- Necropsy of survivors performed:
Animals surviving to the end of the study were anesthetized by CO2 and bled by abdominal aorta to death. Their corpse treatments were entrusted to specialized agencies.
At the end of the test, a gross necropsy was performed on all animals under test. The necropsy included carefully eye examinations of the skin of the dorsal area, the abdominal, thoracic organs and their contents of all animals.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths or moribund status were found in all animals during the test.
Clinical signs:
other: No symptoms were found in all animals' administration skin during the test.
Body weight:
other body weight observations
Remarks:
The results indicated that all the body weight gains of animals showed a growing trend.
Gross pathology:
No abnormalities were found in all animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 in rats for VEC was estimated to be more than 2000 mg/kg b.w. in female SD rats.
Executive summary:

The study was performed to assess the acute dermal toxicity of VEC in Sprague Dawley rats. The method was designed to meet the OECD Guideline 402 under GLP.


The acute dermal LD50 in rats for VEC was estimated to be more than 2000 mg/kg b.w. in female SD rats.