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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: Comparable to guideline with acceptable restrictions (missing data on purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
unknown concentration in vehicle, uncommon dose selection, high dose volume in PEG
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: no data

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
- Mean weight at study initiation per treatment group: males 193-208 g (maximum SD: 13.4 g); females 172-188 g (maximum SD: 9.4)
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages (type 3)
- Diet (e.g. ad libitum): NAFAG, Gossau SG, CH; ad lib.
- Water (e.g. ad libitum): not specified; ad lib.
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%):55+-10
- 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: no data

MAXIMUM DOSE VOLUME APPLIED: 10 and 20 mL/kg bw
Doses:
2000, 3000, 4000 and 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 and weighing: Physical condition and rate of deaths were monitored throughout the whole observation period. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes. The animals were 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:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Dyspnoea, exophthalmus, curved position and ruffled fur were observed in all treatment groups and were reversible within at most 9 days. No further effects observed.
Mortality:
No mortality observed.
Clinical signs:
Dyspnoea, exophthalmus, curved position and ruffled fur were observed in all treatment groups and were reversible within at least 8 days (2000-3000 mg treatment) or 9 days (>=4000 mg).
Body weight:
Normal body weight gain was observed.

Mean weights male/female
2000 mg/kg bw: d0 - 208/188 g; d7 - 255/206 g; d14 - 296/226 g
3000 mg/kg bw: d0 - 205/185 g; d7 - 256/206 g; d14 - 301/223 g
4000 mg/kg bw: d0 - 205/183 g; d7 - 246/215 g; d14 - 284/225 g
5000 mg/kg bw: d0 - 193/172 g; d7 - 246/196 g; d14 - 283/209 g
Gross pathology:
No substance, related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information