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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD guidelines No. 420 “Acute Oral Toxicity – Fixed Dose Method” and in accordance with GLP.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Principles of method if other than guideline:
Guideline followed.
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report)
- Physical state: White powder
- Analytical purity: 99.5%
- Storage condition of test material: Room temperature in the dark.

Test animals

Details on test animals or test system and environmental conditions:
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: 8-12 weeks (All the females were nulliparous and non-pregnant)
- Weight at study initiation: Animal No. 1- 164 g; Animal No. 2-157 g; Animal No. 3-171 g; Animal No. 4-174 g; Animal No. 5-167 g.
- Fasting period before study: overnight fasting immediately before dosing.
- Housing: The animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

- Temperature (°C): 19-25 Deg C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light.

Administration / exposure

Route of administration:
oral: gavage
arachis oil
Details on oral exposure:
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight

DOSAGE PREPARATION (if unusual): The test item was freshly prepared , as required as a suspension in arachis oil with in two hours of dosing.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test item, 2000 mg/kg bodyweight was chosen as a starting dose on single animal.
In the absence of mortality or evident toxicity at a dose level of 2000 mg/kg, an additional group of 4 animals was treated with 2000 mg/kg bodyweight.
Single dose of 2000 mg/kg bodyweight.
No. of animals per sex per dose:
4 female animals for single fixed dose of 2000 mg/kg bodyweight.
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 min, 1, 2 and 4 hour after dosing and subsequently once daily for 14 days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
No mortality or evident toxicity observed at a dose level of 2000 mg/kg bodyweight.
Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality or sign of evident toxicity observed
No mortality
Clinical signs:
other: No signs of systemic toxicity observed
Gross pathology:
No abnormalities noted
Other findings:

Any other information on results incl. tables


Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: EU
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater that 2000mg/kg bodyweight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat following OECD TG No. 420. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of the test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality: There were no deaths.

Clinical observations: There were no signs of systemic toxicity.

Bodyweight: All animals showed expected gains in bodyweight.

Necropsy: No abnormalities were noted at necropsy.

CONCLUSION: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater that 2000 mg/kg bodyweight