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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
source of read across
Adequacy of study:
key study
Study period:
From September 11 to October 04, 2002
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference Type:
study report

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17th December 2001
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
in accordance with SN EN 45001 (incl. certificate)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
Similar Substance 01
Similar Substance 01

Test animals

Details on test animals or test system and environmental conditions:
- Source: RCC Ltd, Biotechnology and Animal Breeding Division CH-4414 Füllinsdorf / Switzerland.
- Age at study initiation: males 9 weeks, females 13 weeks.
- Weight at study initiation: males 235 - 244 g, females178 - 197 g
- Fasting period before study: animals were fasted for 17 to 18 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
- Housing: in groups of three per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- Diet: pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no.34/02.
- Water: community tap water from Füllinsdorf, ad libitum.
- Acclimation period: under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

- Temperature: 22 ± 3 °C
- Relative humidity: between 30-70 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hours fluorescent light/12 hours dark.
- Other: music during the light period.

Administration / exposure

Route of administration:
oral: gavage
polyethylene glycol
(PEG 300)
Details on oral exposure:
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.

- Volume: 10 ml/kg body weight.

The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and ultra-turrax.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight : volume).
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
2000 mg/kg body weight
No. of animals per sex per dose:
3 males or 3 females
Details on study design:
- Duration of observation period following administration: 15 days.
- Mortality/viability: daily during acclimatization and twice daily during days 1 - 15.
- Frequency of weighing: on test days 1 (prior to administration), 8 and 15.
- Frequency of observation: daily during acclimatization and at approximately 1, 2,3 and 5 hours after administration on test day 1. Once daily during days 2 - 15.
- Necropsy of survivors performed: yes.All animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 ml/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examinations were performed. No organs or tissues were retained.
No statistical analysis was used.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
No deaths occurred during the study.
Clinical signs:
other: No clinical signs were observed during the course of the study.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
LD50 (male and female) > 2000 mg/kg bw
Executive summary:

Three male and three female HanBrl: WIST (SPF) rats were treated with test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived untilthe end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were recorded at necropsy.


LD50 (male and female) > 2000 mg/kg bw