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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1967

Materials and methods

Principles of method if other than guideline:
Aqueous solutions of test substance administered in single doses to groups of rats of both sexes by oral intubation. Animals were observed for 7 days after treatment and autopsy was carried out on those animals which died during this period and on randomly selected survivors at 7 days. Acute LD50 values with 95 % confidence limits were calculated by the method of Weil (1952).
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat and mouse
Strain:
other: Carworth Farm Strain E SPF (rat) and ICI Alderley Park Strain 1 SPF (mouse)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Up to 8000 mg/kg
No. of animals per sex per dose:
5/rat/sex/dose
5/mouse/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, colouration

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rat and mouse
Sex:
male/female
Dose descriptor:
LD0
Effect level:
8 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rat and mouse
Mortality:
No
Clinical signs:
No toxic signs. Lethargy for a few hours after dosing.
Other findings:
Slight colouration of animals; coloured material mainly excreted in faeces and to a small extent in urine.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 > 8000 mg/kg in rat and mouse
Executive summary:

Method

Acute toxicity in rat and mouse dosed up to 8000 mg/kg by gavage. Observation up to 7 days and necropsy of survivors randomly selected.

Results

No deaths; lethargy for a few hours; colouration of faeces and urine.

LD50 > 8000 mg/kg.

LD0 = 8000 mg/kg.