Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
experimental group: 14-08-2006 to 30-08-2006; control group: 26-07-2006 to 09-08-2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001-12-17
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
dated 2005-12-13
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

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: treatment group: 9 weeks old; control group: approx. 8 to 12 weeks old
- Weight at study initiation: treatment group: 225 - 242 g; control group: 205 - 225
- Fasting period before study: animals are deprived of food but not water overnight prior to treatment, starting on the previous day. Food was distributed again 4 hours after the product is administered.
- Housing: three animals are kept in each Makrolon cage, dimensions 47 cm x 31 cm x 19 cm, and the bottom is lined with dust-free wood shavings.
- Diet (ad libitum)
- Water (ad libitum): public water supply
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: between 20 and 21°C
- Relative humidity: between 43% and 64%
- Air renewal: at least 10 cycles per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION: the test item VP 112/18 was diluted in dimethyl sulfoxyde and administered by force-feeding using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: systematic examinations are carried out to identify any behavioural or toxic effects on the major physiological functions 30 minutes, 1 hour, 3 hours, 4 hours, 24 hours and 48 hours after administration of the product and continued on the following day. Observations and mortality check are carried out every day during 14 days.
The animals are weighed on day D0 (just before administering the product) then on D2, D7, and D14. Weight changes should be calculated and recorded.
- Necropsy of survivors performed: yes
Necropsies are carried out on animals which died during the test. Macroscopic observations are entered on individual autopsy sheets
On D14, the animals are anaesthetised with sodium pentobarbital and administration continued to fatal levels.
Only those organs likely to be modified in cases of acute toxicity are examined.
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off value: 2500 mg/kg bw
Mortality:
It was noted the death of 1 treated rat, 48 hours following the test item administration, due to a gavage injury. No mortality attributable to the test item administration was noted.

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, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (female rats) > 2000 mg/kg bw (LD50 cut-off value (female rats): 2500 mg/kg bw)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.