Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the text
Title:
Unnamed
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The SNIF file migrated from NONS (67/548/EEC notification) stated the study was performed according to OECD guideline 404 (Acute Dermal
Irritation/ Corrosion). It is assumed that this is an error and OECD guideline 401 (Acute Oral Toxicity) has been listed under 'Test guideline'.
GLP compliance:
yes
Remarks:
No further information was provided in the SNIF file.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CDR
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
1200, 2500, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 577 mg/kg bw
95% CL:
2 651
Mortality:
Male: 1200 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 1200 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 4
Clinical signs:
Signs of toxicity realted to dose levels: Salivation, hyperactivity and diarrhoea was observed in all groups on the day of dosing. In the highest dose groups, nasal discharge and signs of stomach cramps were reported the day after dosing. Tremors, convulsions, irregular breathing and ataxia was observed in the 2500 mg/kg bw group. All animals had a reduced food intake.
Gross pathology:
Effects on organs: changes in the gastrointestinal tract. Animals that died during the observation period partly exhibited changes in the stomach and intestines that indicated an irritating or corrosive effect of the substance.

Applicant's summary and conclusion