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Administrative data

Description of key information

The LD50 of the test item LCA08002 is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline N°423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCA08002 must not be classified. No symbol and risk phrases are required.

In accordance with Globally harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.

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:
2008-05-13 to 2008-05-28
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier (53940 Le Genest St Isle-France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: Between 185g and 213g
- Fasting period before study: at least 5 days
- Housing: group of three in solid-bottomed cleard polycarbonate cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): Tap-water from public distribution system supplied freely (Microbiological and chemical analyses were carried out once every six months)
- Acclimation period: foodstuff supplied freely. Food was removed at D-1 and then redistributed 4 hours after the test item administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Betwwen 19°C and 21°C
- Humidity (%): Between 38% and 52%
- Air changes (per hr): at least ten changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
Test item group : Volume of administration 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 femalle rats at 2000 mg/kg
Control animals:
yes
Details on study design:
Systemic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. These observation were compared to control data. Observation and mortality report were then carried out every day for 14 days.
The animals were weighed on day 0 (just before administrating the test item) then on D2, D7 and D14. weight changes were calculated and recorded.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
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.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The LD50 of the test item LCA08002 is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline N°423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCA08002 must not be classified. No symbol and risk phrases are required.
In accordance with Globally harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.
Executive summary:

The test item LCA08002 was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline N°423 date December 17th, 2001 and the test method B1tris of the directive N°2004/73/EC.

No mortality occured during the study.

No clinical signs related to the administration of the test item were observed.

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 changes.

In conclusion, the LD50 of the test item LCA08002 is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline N°423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCA08002 must not be classified. No symbol and risk phrases are required.

In accordance with Globally harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.

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

Additional information

Justification for classification or non-classification