Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
21 Sep - 05 Oct 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif:RAif (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Body weights at study initiation: males - 175 g; females - 176 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: rat food NAFAG No. 890 NAFAG Gossau SG, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light per day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
400
Details on oral exposure:
VEHICLE
- Amount of vehicle: 20 mL/kg body weight
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 animals/sex
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: physical condition and rate of deaths were monitored throughout the whole observation period; body-weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes; all animals were submitted to a necropsy, whenever they died, survivors at the end of the observation period
- Other examinations performed: gross examination

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured.
Clinical signs:
Dyspnoea, exophthalmos, ruffled fur reported, diarrhoea and curved body position were observed. Nevertheless all symptoms are recovered within 9 days.
Body weight:
No significant differences reported.
Gross pathology:
No compound related gross organs changes were reported.

Any other information on results incl. tables

Signs and symptoms hrs Days
1 2 3 5 24 2 3 4 5 6 7 8 9 10 11 12 13 14
Sedation
Dyspnoea + + + + + + + + + + + +
Dacryorrhoea
Chromodacryorrhoea
Rinorrhoea
Epistaxis
Exophthalmos + + + + + + +
Salivation
Ruffled fur ++ ++ ++ ++ + + + + + + +
Pallor
Cyanosis
Diarrhoea + +
Body position (ventral)
Body position (lateral)
Body position (curved) + + + + + + + + + +
Ataxia
Trismus
Tremor
Tonic clonic muscle spasms
Convulsions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

Method

The acute oral toxicity of the test compound in rats of both sexes was tested at the single concentration of 5000 mg/kg bw and observed over a period of 14 days.

Results

The LD50 is greater than 5000 mg/kg bw.