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Description of key information

Acute oral toxicity study: OECD 423, The DL50 (rats) is higher than 2000 mg/kg (GLP, K1)

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:
21 September to 06 October 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted in compliance with OECD Guideline No. 423 without any deviation.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
10 December 2009
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Robertet / 1898198
- Appearance: Yellow liquid
- Production date: 29 June 2010
- Date received: 10 September 2010
- Expiration date of the lot/batch: 29 June 2012

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle – France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 185-203 g
- Fasting period before study: Food was removed at Day 1 and then redistributed 4 h after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: Foodstuff (M20-SDS), ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: ca. 15 changes per hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: 21 September to 06 October 2010
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.07 mL/kg bw

TEST ITEM ADMINISTRATION:
- Test item was administered by gavage under a volume of 2.07 mL/kg bw corresponding to 2000 mg/kg bw (according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females/dose
Control animals:
yes
Remarks:
Current Control Study TAO-2010-004 (distilled water at 10 mL/kg bw)
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. Observations and a mortality report were then carried out every day for 14 days. Animals were weighed on Day 0 (just before administering the test item) then on Days 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were euthanized by sodium pentobarbital administration and animals were subjected to macroscopic observations.
Statistics:
None
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed. Indeed, only an increased in salivation was noted between 30 minutes and 3 hours post-dose in one animal.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).
In accordance with the OECD guideline N° 423, the LD50 cut-off may be considered higher than 5000 mg/kg bw by oral route.
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

 

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. Indeed, only an increased in salivation was noted between 30 minutes and 3 hours post-dose in one animal. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related change.

 

Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

 

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. Indeed, only an increased in salivation was noted between 30 minutes and 3 hours post-dose in one animal. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related change.

 

Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).

Justification for classification or non-classification

Self classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw