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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:
guideline study

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
Test material form:

Test animals

Details on test animals or test system and environmental conditions:
Species Rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality).Recognized by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Age and body weight Young adult animals (approx. 8 weeks old) were selected.
Body weight variation did not exceed +/- 20% of the sex mean.
Identification Earmark and tail mark
Health inspection At least prior to dosing. It was ensured that the animals were healthy and without any abnormality that might have affected the study integrity.

Environmental controls for the animal room were set to maintain 18 to 24°C, a relative
humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle.
Any variations to these conditions were maintained in the raw data and had no effect on the
outcome of the study.
Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
Details on oral exposure:
Method Oral gavage, using plastic feeding tubes. The test item was
stirred on a magnetic stirrer during dosing.
Fasting Animals were deprived of food overnight prior to dosing and
until 3-4 hours after administration of the test item. Water was
available ad libitum.
Frequency Single dosage on Day 1.
Dose level (volume) 2000 mg/kg (2.34 mL/kg) body weight.
Dose volume calculated as dose level (g/kg) / specific gravity.
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 females
Control animals:
Details on study design:
The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The
first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of
animals dosed at one step determined the next step, based on the test procedure defined in the
guidelines. The onset, duration and severity of the signs of toxic

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Twice daily.
Clinical signs:
At periodic intervals on the day of dosing (Day 1) and once
daily thereafter, until Day 15. The signs were graded according
to fixed scales and the time of onset, degree and duration were
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Body weight:
Days 1 (pre-administration), 8 and 15.
Gross pathology:
At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic
abnormalities were recorded.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The oral LD50 value of GR-50-3010 in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

Assessment of acute oral toxicity with GR-50-3010 in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in:

OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"

Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class


EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"

JMAFF Guidelines (2000), including the most recent revisions.

GR-50-3010 was administered by oral gavage to two consecutive groups of three female

Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and

weekly determination of body weight. Macroscopic examination was performed after

terminal sacrifice (Day 15).

No mortality occurred.

Lethargy, flat posture, hunched posture, uncoordinated movements, piloerection, salivation, shallow respiration and/or ptosis were noted for all animals on Day 1.

The mean body weight gain shown by the animals over the study period was considered to be normal.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of GR-50-3010 in Wistar rats was established to exceed 2000 mg/kg body weight.