Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2014-12-01 to 2014-12-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: GB/T 21606-2008 Chemicals-Test method of acute dermal toxicity
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
authorized by CNAS
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Purity: 100.0%
- Lot No.: KNC110310

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Slac Jingda Laboratory Animal Co., Ltd, Hunan Province
- Weight at study initiation: 208 ~ 232 g
- Housing: housed in SPF Barrier environment
- Diet: AII ofthe feeds were supplied by Tianqin biotechnology Ltd, Changsha
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 56-69

Administration / exposure

Type of coverage:
occlusive
Vehicle:
methylcellulose
Details on dermal exposure:
About 4 cm x 5 cm areas of fur was clipped from the rats' back at 24 h before dosing. An amount of test item was grinded and then diluted into required concentration 500 mg/mL for the test with 1 % methylcellulose solution. The dosing Iiquids was equably applied to the smooth area (approximately 10 percent of the body surface area) of the rats in a single dose (0.4 mL/100 g BW) . The area of application was covered with a 2 ply in surgical gauze patch and secured in non-irritating adhesive tape.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 femles and 5 males
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 daily thereafter for 14 days. Body weights were records at Day 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the 14 days
Clinical signs:
No detectable clinical signs occurred in any test animals during the 14 days.
Body weight:
Individual body weights increased at the 7th and 14th day after dosing.
Gross pathology:
No abnormal necropsy findings occurred in any test animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the test substance for male and female rats was estimated to be over 2000 mg/kg.
Executive summary:

The acute dermal median lethal dose and the health hazards of the test substance to SD rats were determined in accordance with GB/T 21606-2008 Chemicals-Test method of acute dermal toxicity. One single dose of 2000 mg/kg was chosen.

No detectable clinical signs occurred in any test animals, and no death occurred during the 14 days. Individual body weights increased at the 7th and 14th day after dosing. No abnormal necropsy findings occurred in any test animal.

The acute dermal LD50 of the test substance for male and female rats was estimated to be over 2000 mg/kg.