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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February/March 2015
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Test material form:
liquid - solid: mixture of
Specific details on test material used for the study:
- Stability under test conditions: The stability of the substance in the formulation was analytically verified for at least 48 hours.
- The substance in the test item is dissolved in approx. 30 % solvent. Test concentrations in the acute oral toxicity study were adjusted to the substance content (approx. 70 %).

Test animals

Details on test animals or test system and environmental conditions:
- Strain: RCCHan:WIST
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 8-12 weeks
- Weight at study initiation: 168-192 g
- Fasting period before study: Food was withheld from the animals for approximately 16-24 h before administration of the test item, and they were fed again approximately 2-4 h after administration.
- Housing: The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
VEHICLE: The test substance was formulated in corn oil with the aid of 10 % acetone (dried with molecular sieve).

Administration volume: 10 mL/kg bw

2000 mg/kg bw (the test item content was considered)
No. of animals per sex per dose:
6 (3 animals per step)
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily. The weight gain was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
The LD50 value was estimated according to OECD TG 423 (2001).

Results and discussion

Effect levels
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: cut-off level according to OECD TG 423, Annex 2d
There were no deaths.
Clinical signs:
No clinical signs were observed.
Body weight:
There were no toxicologically significant effects on body weight or body weight gain.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to OECD TG 423 (Acute Toxic Class Method) was conducted on 6 female rats (3 per step), receiving each a single dose of 2000 mg/kg of the substance formulated in corn oil (the content of the substance in the test item, which is approx. 70 % in approx. 30 % solvent, was considered). No mortalities, no clinical signs, no effects on body weight gain and no gross pathological findings were observed. Therefore, according to the flow chart of the OECD TG 423, Annex 2d, the LD50 cut off for the substance is 5000 mg/kg bw, and the discriminating dose is 2000 mg/kg.