Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 2 to 17, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted in compliance with OECD Guideline No. 401 without any deviation.

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 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
31 July 1992
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Storage conditions: Room temperature in the dark
- Appearance: clear colorless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage IFFRA CREDO (69210 L'Arbresle, France)
- Age at study initiation: 5-7 weeks
- Weight at study initiation: M: 190.5-209.4 g / F: 175.8-198.4 g
- Fasting period before study: Animals were fasted before dosing and then for 3-4 h after dosing.
- Housing: Animals were housed in groups of 5 in polypropylene cages.
- Diet: Pelleted diet, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: May 02, 2001 To: May 17, 2001

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
PEG 300
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.37 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighting: On test days -1, 1 (prior to administration), 4, 8 and 15
- Frequency of observations:
Mortality / viability/ clinical observations: during the first 30 minutes and at approximately 1, 2, 3,4, 5 and 6 hours after administration on test day 1 (with the clinical signs) and at least only daily thereafter.
- Necropsy of survivors performed: Yes; All animals were killed at the end of the observation period by intraperitoneal injection of Pentaboarbital sodique
Statistics:
None

Results and discussion

Preliminary study:
See below
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
No effects
Gross pathology:
No macroscopic findings were recorded at necropsy
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (combined) > 2000 mg/kg bw. Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, male and female Sprague-Dawley rats were administered a single oral dose of 2000 mg test material/kg bw by gavage. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

All animals survived until the end of the study period. No clinical signs nor effects on body weight were reported during the course of this study. No macroscopic findings were recorded at necropsy.

LD50 (combined) > 2000 mg/kg bw

Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.