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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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(10/14 hour dark/light cycle, acclimation period = 4 days)
GLP compliance:
no
Remarks:
prior GLP
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
- Source: Ciba Geigy Ltd.
- Weight range at study initiation: 160 - 180 g
- Fasting period before study: overnight
- Housing: 5/cage (macrolon cages type IV)
- Diet: ad libitum; NAFAG Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 %
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION: The test substance was suspended with polyethylene glycol (PEG 400). Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
4,640, 7,750 and 10,000 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 weighing: at least once (before application)
- Frequency of observation: after 1, 24, 48 hours, on day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died in the mid dose on day 14. No deaths were recorded in the low and high doses.
Clinical signs:
Within two hours of dosing, rats in all dose groups experienced sedation, dyspnoea, exophthalmus, curved position and ruffled hair. The surviving animals recovered within 8 days.
Body weight:
no data
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met