Registration Dossier

Administrative data

Description of key information

Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats; OECD 401, K, rel.1);

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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
Preliminary study:
See below
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

None

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is GLP-compliant and of high quality

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Not required for an Annex VII dossier

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Not required for an Annex VII dossier

Additional information

Acute toxicity: oral

A key study was identified (Evik, 2001, Rel.1). In this 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

 

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Acute toxicity via Oral route:

Based on the available data the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as the oral LD50 is higher than 2000 mg/kg bw and no effects were observed at this dose level.

Acute toxicity via Dermal route:

No data was available.

Acute toxicity (Inhalation):

No data was available.

Specific target organ toxicity: single exposure (Oral):

Based on the available data, the classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

No data was available

Specific target organ toxicity: single exposure (Inhalation):

No data was available.

Based on its composition (> 10% of aspiration toxicants), and description as mobile (see IU section 4.1 -4.2) the substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.