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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2015-01-29 to 2015-04-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
2004
Deviations:
no
GLP compliance:
no
Remarks:
non GLP, but in compliance with China National Metrology Accreditation
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium bis[ethanedioato(2-)-κO1,κO2]difluorophosphate(1-)
EC Number:
695-938-6
Cas Number:
678966-16-0
Molecular formula:
F2C4PLiO8
IUPAC Name:
Lithium bis[ethanedioato(2-)-κO1,κO2]difluorophosphate(1-)
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch No.: 141104
Purity: 95.4%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 - 9 weeks.
- Weight at study initiation: 200 to 300 g.
- Housing: 5 per cage by sex
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum from bottled water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12-hour light / dark cycle.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
vegetable oil
Details on dermal exposure:
TEST SITE
- Area of exposure: not less than 10% of the total body surface area
- Type of wrap if used: orthopedic stockinette.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes - washed with room temperature tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): four dosage levels (215, 464, 1000, 2150 mg/kg) in female rats and male rats
- Concentration (if solution): N/A - administered as supplied
Duration of exposure:
24 h
Doses:
four dosage levels (215, 464, 1000, 2150 mg/kg) in female rats and male rats
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical/behavioral signs of toxicity were made at least two times on the day of dosing (Day 0) and at least once thereafter for 14 days. Bodyweights were recorded just prior to dosing and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic pathology.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
501 mg/kg bw
Based on:
test mat.
95% CL:
> 344 - < 730
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
926 mg/kg bw
Based on:
test mat.
95% CL:
> 636 - < 1 350
Mortality:
Death occurred in female rats at 464, 1000, 2150mg/kg levels and male rats at 1000, 2150mg/kg levels. The acute dermal LD50 wás estimated to be 501 mg/kg in female rats (95% confidence interval is 344 to 730mg/kg) and 926 mg/kg in male rats (95% confidence interval is 636 to 1350mg/kg). according to Horn's method.
Clinical signs:
other: During experiment observation, clinical signs such as tremors and subject skin with varying degrees of poisoning symptoms (nigrescence, edema, necrosis, easy off) were found in 215, 464, 1000, 2150 mg/kg dose group of male and female rats, after 3 days th
Gross pathology:
No abnormal necropsy findings occurred in any test animal which could be suspected to be due to the test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The acute dermal LD50 was estimated to be 501 mg/kg in female rats (95% confidence interval is 344 to 730 mg/kg) and 926 mg/kg in male rats (95% confidence interval is 636 to 1350 mg/kg). Based on these results, it was concluded that application of the test substance was moderately toxic by acute dermal route.
Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley rat according to OECD Guideline 402: Acute Dermal Toxicity test (Ministry of Environmental Protection of the People's Republic of China, 2004).

The test material was evaluated for its acute dermal toxicity potential and relative skin irritancy in rats. 20 fernale and 20 male SD rats were randomly divided into 4 groups respectively for 24 hours by acute dermal route. Treated groups were dosed with the test material at 215, 464, 1000, 2150 mg/kg for female and male rat, respectively. Parameters measured during the exposure and observation period were body weight changes, clinical signs, mortality, and local irritation.

During experiment observation, clinical signs such as tremors and subject skin with varying degrees of poisoning symptoms (nigrescence, edema, necrosis, easy off) were found in 215, 464, 1000, 2150 mg/kg dose group of male and female rats, after 3 days the survivor appeared a black scab which was start off in 6 weeks and then returned to recovery. Death occurred in female rats at 464, 1000, 2150 mg/kg levels and male rats at 1000, 2150 mg/kg levels.

The acute dermal LD50 was estimated to be 501 mg/kg in female rats (95% confidence interval is 344 to 730 mg/kg) and 926 mg/kg in male rats (95% confidence interval is 636 to 1350 mg/kg). Based on these results, it was concluded that application of the test substance was moderately toxic by acute dermal route.

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