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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15th June 2018 to 10th July 2018
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
other: Guidelines for the testing of chemicals "Acute Dermal Toxicity" (TG 402) published by the Ministry of Environmental Protection of People's Republic of China in 2013
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Specific details on test material used for the study:
Batch No. BO1801B009

Test animals

Details on test animals or test system and environmental conditions:
Physical check up and acclimation were made to all animals on arrival. Healthy young animals were acclimatised to the laboratory conditions and housed two per cage in the facility of Room D101 for 7 days prior to the test. All animals were weighed and marked on the hair. Clinical observations were performed daily until grouping. Animals were raised in suspended stainless steel cages. Animals were housed individually during the test.
Temperature: 20-25oC
Humidity: 40-70%
Light sequence: 12 hour light / 12 hour dark
Food: Sterilised diet with complete nutrition (Beijing keaoxieli Feed Co. Ltd.)
Water: ad libitum

Administration / exposure

Type of coverage:
corn oil
Details on dermal exposure:
According to body weights, the theoretical amounts of the test item were calculated.

Theoretical Weighed Test Item (mg/animal) = Body Weight (kg) x Dose (mg/kg)

The test item was weighed on a piece of gauze (6cm x 6cm) stuck on a small piece of medical tape (non-irritating) moistened with 0.5ml vehicle. Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animal by clipping. Only animals with healthy and intact skin were used. 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 test item.
Duration of exposure:
24 hours
No. of animals per sex per dose:
Details on study design:
Clinical observations were performed once during the first 30 mins and at 1, 2 and 4 hours, then once each day for 14 days.

Careful observations and records of fur changes, eye & mucosa, respiratory, circulatory, nervous system, limb activity and behavioural changes. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethary, sleep and coma

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
No deaths or moribund states were observed during the test
Clinical signs:
other: There were no abnormal findings in all animals during the test
Gross pathology:
No abnormalities were found in all animals at necropsy

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Based on the results, an acute dermal LD50 in rate for E Stage 3 intermediate was estimated to be above 2000 mg/kg. According to the GHS's classification criteria for acute dermal toxicity, the test item was classified as "Category 5" or unclassified
Executive summary:

The study was performed to assess the acute dermal toxicity of E Stage 3 intermediate in Sprague Dawley rats. The mehtod was designed to meet the guidelines for the testing of chemicals "Acute Dermal Toxicity" (TG 402) published by the Ministry of Environmental Protection of People's Republic of China in the year of 2013.

A limit test at one dose level of 2000mh/kg body weight was carried out via dermal route in a group of 10 animals (5 males and 5 females). Clinical observations were made during the first 30 minutes and a 1, 2, and 4 hours after dosing and then once each day for up to 14 days. Individual weights of animals were determined within 24 hours of arrival, at grouping, on Day 0 (day of dosing), Day 7 and Day 14. At the end of the test, a gross necropsy was performed on all animals under test.