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Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2019-05-28 to 2019-06-21
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
Specific details on test material used for the study:
Batch No.: 707001
Purity: 98.5%

Test animals

Details on test animals or test system and environmental conditions:
- Source: SPF (Beijing) Biotechnology Co., Ltd.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 56-78 days
- Weight at study initiation: 240-280 g
- Fasting period before study: not fasted
- Housing: Animals were raised in suspended, stainless steel cages (L32.0cm × W60.0cm× H20.0cm) on cage racks (Ll99.0cm x W70.0cm x H 171.0 cm). There were 3 cages per layer and 4 layers per rack. Animals were housed individually during the exposure period and returned to group housing after the exposure period.
- Diet: SPF rodent maintenance feed, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

- Temperature (°C): 21.9 - 25.0
- Humidity (%): 42 - 69
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
not specified
unchanged (no vehicle)
Details on dermal exposure:
Administration method:
- Fur Removing: Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping. Care was taken to avoid abrading the skin, which could alter its permeability. Clear area was about 40 cm2. Only animals with healthy and intact skin were used.
- Dosing Frequency: Each animal was dosed once.
- Dosing: The test item was applied evenly to the treatment area. The gauze was placed over the treatment area and wrapped with a piece of self-adhesive bandage. Shortly after dosing the dressings were examined to ensure that the animals cannot ingest the test item.
- Rest Test Item Removing: At the end of the exposure period after approximate 24 hours, residual test item was removed by cotton wool soaked in water.
The time intervals of each animal’s dosing were 2-5 days.

- Amount(s) applied (volume or weight with unit): administered as supplied at a variable dose volume calculated in accordance with the design of dose and animal body weight
Duration of exposure:
24 h
2000 mg/kg bw
No. of animals per sex per dose:
Control animals:
not required
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.
Individual weights of animals were determined within 24 hours after arrival, at grouping, on Day 0 (day of dosing), Day 7 and Day 14.
- Necropsy of survivors performed: yes, Animals surviving to the end of the study were anesthetized by CO2 and bled by abdominal aorta to death.

Results and discussion

Preliminary study:
No mortality occurred and no sign of systematic toxicity observed, the body weights showed growth trends, no abnormalities detected at all test levels.
Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No deaths or moribund status were found
Clinical signs:
other: No abnormal symptoms were found
Gross pathology:
No abnormalities were found in all test animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Based on the results, the acute dermal LD50 in rats for test item was estimated to be more than 2000 mg/kg b.w..
Executive summary:

The study was performed to assess the acute dermal toxicity of test item in Sprague Dawley rats based on OECD 402. A dose-range finding study with dose levels of 200, 1000, 2000 mg/kg b.w. and a main study with dose levels of 2000 mg/kg b.w. were carried out and five female animals were used.

No deaths or moribund status and no abnormal symptoms were found in all test animals from dosing until the end of the test. The body weights of two test animals with dose levels of 2000 mg/kg b.w. showed decrease trends during most of the observation periods. The body weights of the other test animals showed growth trends during most of the observation periods. No abnormalities were found in all test animals at necropsy.

Based on the results, the acute dermal LD50 in rats for test item was estimated to be more than 2000 mg/kg b.w..