Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-04-19 to 2000-06-16
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- form: solid
- storage: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Twenty OFA Sprague Dawley rats (SPF Caw) originated from IFFA CREDO (69210 L’Arbresle –France), were kept during a 5-day acclimatisation period. At the beginning of the study, the animals weight was contained between 173 g and 195 g (males) and between 164 g and 179 g (females).
Control group: 5 male rats and 5 female rats
Treated group: 5 male rats and 5 female rats

Environmental parameters:
- temperature : between 19°C and 23°C
- relative humidity: between 47% and 59%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
paraffin oil
Details on oral exposure:
As the test product was presented as solid form, the following solution has been prepared:
6 g of the test product reduced in powder with a mortar was mixed with parafin oil (q.s.p. 60 ml) under magnetic shaking to obtain a solution at 2g/20 ml.
Doses:
2000 mg/kg bw in a volume 20 ml/kg bw
No. of animals per sex per dose:
5 female rats
5 male rats
Control animals:
yes
Details on study design:
- 2 groups rats: control (vehicle= paraffin oil) and treated rats
- treatment: 2000 mg/kg bw in 20 ml/kg bw
- administration by fore-feeding using suitable syringue graduated fitted with an oesophageal metal canula
- clinical observation of the rats: 1, 5, 24 and 48 hours after the gavage
- body weight evolution: 2, 7 and 14 days after the gavage
- macroscopical examination if the rats at the end if the study (D14)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occured during the study
Clinical signs:
No clinical signs related to the administration of the test product were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test product is higher than 2000 mg/kg body weight by oral route in the rat.
Executive summary:

The test product was administered to a group of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline no 401 dated February 24th, 1987 and the test method B.1 of the E.E.C. Directive no 92/69 dated December 29th, 1992. No mortality occurred during the study. No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the product LCE00051 is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 93/21, the product LCE00051 must not be classified.