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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:
March - April 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
usage of 5 male and 5 females animals
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was suspended to achieve a concentration suitable for the selected dose levels.

FORM AS APPLIED IN THE TEST (if different from that of starting material): suspended in Polyethylene glycol 400 (PEG 400)

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY limited
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: males: 191 g (mean); females: 185 g (mean)
- Fasting period before study: yes, overnight
- Housing: 5 animals/cage
- Diet: NAFAG No. 890 , NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw
Doses:
5000 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: 1/2/3/4/5/24 hours after applikation of the test substance and daily thereafter until day 14
- Frequency of weighing: on the day of applikation of the test substance (day 1), day 7 and day 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no mortality observed
Clinical signs:
- sedation (from 1 h until 24 h after treatment)
- slight dyspnoea (from 1 h until day 6 after treatment)
- slight exophthalmos (from 1 h until day 5 after treatment)
- ruffled fur (moderate from 1 h until 24 h after treatment and slight until day 6 after treatment)
- slight diarrhoea (from 5 h until 24 h after treatment)
- slightly curved body position (from 1 h until day 5 after treatment)
Body weight:
no effects observed
Gross pathology:
no effects observed

Any other information on results incl. tables

The animals recovered within 7 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material is therefore practically non toxic to the rat by this route of administration.