Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OCDE guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Container: plastic tube
Quantity: 118.8 g (container + content)
Batch: 4359 MP
Density at room temperature: 1.32
Form: thick liquid
Colour: yellow - brown
Storage: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
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 176 g and 210g (males) and between 159g and 182g (females).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
aucun
Details on oral exposure:
The administration was done by force-feeding under a volume of 1.51 mL/kg body weight using a suitable syringe graduated fitted with an oesophagal metal canula. The dose received was 2000 mg/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: >= 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: >= 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
no clinical signs related to the administration of the test product.

Evolution du poids normal sur 14 j.
Body weight:
Evolution remained normal.
Gross pathology:
Effects on organs:
macrsocopical examintaion 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:
The LD 50 of the product LCA 01006 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 EEC directives 67/548 and 93/21, the product LCA 01006 must not be classified "R28: very toxic if swallowed", "R25: toxic if swallowed" or " R22: harmful if swallowed".
Executive summary:

The product LCA 01006 was administrated 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 OECD guideline n°401 dated February 24th, 1987 and the test method B.1 of the Directive n°92/69/EEC dated December 29th, 1992.

No mortality occured during the study.

No clinical signs related ti the administration of the test ptoduct were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

The macrsocopical examintaion of the animals at the end of the study did not reveal treatment related changes.

In conclusion, the LD50 of the product LCA 01006 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 EEC directives 67/548 and 93/21, the product LCA 01006 must not be classified.