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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:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Acute Dermal Toxicity (TG402, adopted 1987).
GLP compliance:
yes (incl. certificate)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 97%
- Source: Aldrich Chemical Company, Milwaukee, WI, USA
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DSM Engineering Plastics B.V. lotnumber SN0620140520
- Expiration date of the lot/batch: 2016.07.01
- Purity test date: 99.93%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in a cool area (IO-20°C). Containers that have been opened must be filled with dry nitrogen for at least 1min and then sealed. Be careful not to import any water or impurities during the filling and sealing course.
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: Easily soluble in cold water


FORM AS APPLIED IN THE TEST white waxy solid

Test animals

Species:
rat
Strain:
other: Sprague Dawley (SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 56-65 days on arrival, in the range of 8-12 weeks at the commencement of each animal’s dosing.
- Weight at study initiation: Body weight range: Males: 23 5-270g. Females: 225-235g, +/- 20% of the mean body weight at grouping.
-
- Housing: Animals were housed individually during the test.
- Diet : provided sterilized diet with complete nutrition supplied by Beijing keaoxieli Feed
- Water : Purified water
- Acclimation period: 5 days prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0-24.5"C
- Humidity (%): 45%-70%
- Photoperiod (hrs dark / hrs light): light cycle was 12 hour light/ 12 hour dark.

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: fur removed from dorsal area by shaving, clear area 40cm2. A gauze 5cm x 5.50m is used

- Type of wrap if used: small piece of white medical tape(non-irritating)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): esidual test item was
removed by cotton wool soaked in water.
- Time after start of exposure: approximated 24 hour

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): test item was moistened with the vehicle
- Purity: purified water
Duration of exposure:
Approximately 24 hours
Doses:
2000
No. of animals per sex per dose:
5 Male
5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: Clinical observations were made during the first 30 min, and at 1, 2 and 4 hours after dosing and then once each day for up to 14 days.
- Frequency of observations and weighing: ndividual weights of animals were determined at grouping, Day 0(day of dosing), Day7 and Dayl4
- Necropsy of survivors performed: yes
- Other examinations performed: Careful observation and record of animal fur changes, eyes and mucosa, respiratory, circulatory, nervous system, particularly limb activity and behavior change were made. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths or moribund during the test.
Clinical signs:
There were no abnormal findings in all animals after dosing from the first day until the
end of the test.
Body weight:
One male and three female animals showed a decrease in body weight during the first
week. But overall also these animals showed growth during the second week. The
results indicated that the body weight gain of animals showed growth.
Gross pathology:
No abnormalities were found at necropsy
Other findings:
Skin Reactions: There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
other: Category 5 or unclassified.
Conclusions:
Conclusion: Based on the results, the acute dermal LD50 in rats for Succinonitrile was as follows:
Male rats :>2000mg/kg b.w.
Female rats :>2000mg/kg b.w.
According to the GHS’s classification criteria of acute dermal toxicity, the test item was classified as Category 5 or unclassified.
Executive summary:

Introduction: The study was performed to assess the acute dermal toxicity of

Succinonitrile in Sprague Dawley rats. The method was designed to meet the OECD

Guideline for Testing of Chemicals: Acute Dermal Toxicity (TG402, adopted 1987).

Method: A limit test at one dose level of 2000mg/kg body weight was carried out in a

group of 10 animals (5 males and 5 females). Clinical observations were made during

the first 30 min, and at 1, 2 and 4 hours after dosing and then once each day for up to 14

days. Individual weights of animals were determined at grouping, Day 0(day of dosing),

Day7 and Dayl4. At the end of the test, a gross necropsy was performed on all animals

under test.

Results:

Mortality

There were no deaths or moribund during the test.

Clinical observations

There were no abnormal findings in all animals after dosing from the first day until the

end of the test.

Skin Reactions

There were no signs of dermal irritation.

Body Weight

One male and three female animals showed a decrease in body weight during the first

week. But overall also these animals showed growth during the second week. The

results indicated that the body weight gain of animals showed growth.

Necropsy

No abnormalities were found at necropsy.

Conclusion: Based on the results, the acute dermal LD50 in rats for Succinonitrile was

as follows:

Male rats :>2000mg/kg b.w.

Female rats :>2000mg/kg b.w.

According to the GHS’s classification criteria of acute dermal toxicity, the test item was

classified as Category 5 or unclassified.