(aminoalkyl) hydrogen thiosulfate

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: GB/T 21606-2008 Chemicals-Test method of acute dermal toxicity

Deviations:

no

Test guideline 2

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

Test material information

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.