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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no data on test substance purity).
Justification for type of information:
Category approach as part of CSR.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

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:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Tif : RAIf (SPF) strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breed
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: mean(males): 185 g; mean(females): 168 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: Rat food - NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
(PAG 400)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw (2000 mg/kg) or 20 mL/kg bw (3000 or 4000 mg/kg bw)

DOSAGE PREPARATION (if unusual):The test substance was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:
2000, 3000, 4000 mg/kg bw (No higher doses were possible).
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 and weighing: Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days. Physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality; unspecific clinical signs observed
Mortality:
No mortality observed.
Clinical signs:
Sedation, dyspnoea, exophthalmos, ruffled fur, curved body position and diarrhoea were observed. The animals recovered within 6 to 9 days.
Body weight:
One male and one female animal of the 4000 mg/kg bw dose group lost weight at the second half of the study period (between day 7 and day 14 of the observation period:

Male animal: day 7: 239 g, day 14: 236 g (- 1.2%)
Female animal: day 7: 205 g, day 14: 113 g (-45%)

Because the strong weight loss was only seen in one animal, this effect was seen as incidental and not as test substance related.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information