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Toxicological information

Acute Toxicity: oral

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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: Acceptable study report with restrictions (no data on test substance purity and body weight development, no GLP)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
other: Correspondence
Title:
Unnamed
Year:
1989
Report Date:
1989
Reference Type:
publication
Title:
Unnamed
Year:
2001
Reference Type:
publication
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no data on test substance purity and body weight development)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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
- Weight at study initiation: 160-180 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet (ad libitum): rat food - NAFAG, Gossau SG
- Water (ad libitum)
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 % of Formulation

DOSAGE PREPARATION: Before treatement the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
4640, 6000, 7750 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes (submitted at random to a necropsy at the end of the observation period)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occured.
Mortality:
No mortality occured.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoe, curved position and ruffled fur. The animals recovered within 8 to 9 days.
Body weight:
No data
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion