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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:
18.10.2001 - 23.11.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: commercial grade
- Lot/batch No.: 766/130
- Expiration date of the lot/batch: 31-AUG-2003
- Stability under test conditions: 4 hours
- Storage condition of test material: at room temperature (range of 17-23°C). In a closed container in the dark.

Test animals

Species:
rat
Strain:
other: HanBrl: Wist
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fullinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks, Females: 10 weeks
- Mean weight at study initiation: Females: 174.27 g; Males: 203.6 g
- Fasting period before study: 16 to 20 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
- Housing: three per sex in Makrolon type-4 cages
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 73/01 (Provimi Kliba AG, Kaiseraugst/ Switzerland), ad libitum.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial performed before experimental starting date.
- Lot/batch no. (if required): 424718/142701

DOSAGE PREPARATION (if unusual): The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The mixtures were prepared using a glass stick first then a magnetic stirrer.
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality / Viability: Daily during acclimatization and twice daily during days 1-15.
Body weights: On test days 1 (pre-administration), 8 and 15.
Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy: All surviving animals were killed at the end of the observation period and discarded after macroscopic examinations were performed. No organs or tissues were retained.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical signs were observed.
Mortality:
No deaths occurred.
Clinical signs:
Slight emaciation was evident in one female on the test days 5 and 6. All other animals were without clinical signs.

Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was determined to have an acute oral LD50 >2000 mg/kg bw (in the rat) under the conditions of the test. The substance is not orally toxic.
Executive summary:

In this guideline (OECD 423) study conducted with GLP, the acute oral LD50 of the test material (EC 438-340-0) to rats was determined to be >2000 mg/kg bw (both sexes). The test material was administered via gavage at a dose of 2000 mg/kg bw. The result of the test was not sufficient to trigger classification and labelling of the test material for acute toxicity under the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).