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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 April 1998 to 21 May 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
FEDERAL DEOARTMENT OF THE INTERIOR, Bern (Switzerland)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: HanIbm: WIST (SPF)
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males) and 10 weeks (females)
- Weight at study initiation: 206-216 g (males), 171-190 g (females)
- Fasting period before study: 17.5-19.5 hours prior to treatment, and 3.5 hours after treatment
- Housing: Groups of 3 in Makrolon type-4 cages with standard softwood bedding ("Lingocel", Schill AG, CH-4132 Muttenz)
- Diet: Pelleted standard Kliba 3433, batch nos 94/97 and 20/98 rat maintanance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) ad libitum. Results of analyses for contaminants are archived at RCC.
- Water: Community tap water ad libitum. Results of bacteriological, chemical, and contaminant analyses are archived at RCC.
- Acclimation period: one week under laboratory conditions, after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 40-66
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (Music was played during the light period.)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: The test article was readily soluble in corn oil.

MAXIMUM DOSE VOLUME APPLIED: 10 ml

DOSAGE PREPARATION: The preperation was made shortly before dosage as a weight by volume preparation. Homogeneity of the test article in the vehicle was maintained during treatment.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit-dose
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Four times during test day 1 and once daily during days 2-15
- Frequency of weighing: On test day 1 (pre-administration), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No statistical analysis was used as no deaths occured.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the study.
Clinical signs:
No clinical signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested for acute oral toxicity according to the OECD TG 423 and in complinance with GLP. No deaths occurred and no signs of toxicity were observed. The LD50 for both males and females was found to be > 2000 mg/kg bw. Hence, classification according to 67/584/EEC and EC/1272/2008 is not warranted.