Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NEB654 COND
- Physical state: colourless liquid
- Lot/batch No.: A13 04 A0022
- Expiration date of the lot/batch: December 2013
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
First step: volume of 1.65 mL/kg bw (corresponding to 2 g/kg according to the calculated density)
Second and third steps: 0.25 mL (corresponding to 300 mg according to the calculated density)
Doses:
2000 and 300 mg/kg bw
No. of animals per sex per dose:
3

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Death of the three rats treated at 2000 mg/kg bw.
No mortality in animals treated at 300 mg/kg bw.
Clinical signs:
The mortality were preceded by absence or decrease in spontaneous activity, myosis, total or partial ptosis and piloerection.
No clinical signs related to the administration of the test item were observed in animals treated at 300 mg/kg.
Body weight:
Normal.
Gross pathology:
The macroscopic examination of the animals treated at 2000 mg/kg did not reveal treatment related changes.
The macroscopic examination of the animals treated at 300 mg/kg did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item is higher than 300 mg/kg and lower than 2000 mg/kg bw by oral route in the rat. The LD50 cut-off may be considered as 500 mg/kg bw.