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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:
guideline study with acceptable restrictions
Remarks:
non-GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
May 12, 1981
Qualifier:
according to
Guideline:
other: Off. J. Europ. Commun. L 257, 83/467/EEC
Version / remarks:
September 16, 1983
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- SIS No.: 20755
- RIS No.: 51Z9900452000
- Delivery: shortly before treatment
- Aggregate state at 20 °C: liquid
- Colour: yellowish
- Active substance content: 20%
- Stability in solvent: stable in aqua dest., preferred
- Storage: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: mean male: 199 g; mean female: 156 g [1st experiment, low dose]; mean male: 225 g; mean female: 163 g [2nd experiment, high dose]
- Fasting period before study: 15 hours before dosing
- Housing: Groups of 2 animals in Makrolon cages Type 3 with standard woftwood bedding, ARWI-center, Essen, Germany
- Diet: Pelleted Altromin Maintenance Diet 1314 (Fa. Altromin GmbH, Germany); ad libitum
- Water: Community tap water from Düsseldorf; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 45-71
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Aqua dest.
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
200 and 2000 mg/kg body weight
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/toxicity symptoms were checked at frequent intervals during test day one and twice daily during days 2-14 (working days). The animals were weighed on the day before the application, on the day of application, on day 2, 7 and 14 after application
- Necropsy of survivors performed: yes, macroscopic examination of all external orifices and the organs in thoracic and visceral cavity.
Statistics:
Not applicable.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
Some animals (males and females) showed after the application reduced activity, piloerection and difficulty of breathing (dyspnoea). Three hours later there were no symptoms observed.
Body weight:
Mean body weight at day of application, on 2, 7 and 14 days after application, respectively:
- males, dose 200 mg/kg bw: 199, 212, 230 and 251 g
- males, dose 2000 mg/kg bw: 225, 239, 259 and 288 g
- females, dose 200 mg/kg bw: 156, 165, 168 and 179 g
- females, dose 2000 mg/kg bw: 163, 174, 180 and 191 g
Gross pathology:
- males, dose 200 mg/kg: no macroscopic findings were considered to be treatment related. One male had no feces in the rectum and the rectum was slight dilated.
- females, dose 200 mg/kg: no macroscopic findings were considered to be treatment related.
- males, dose 2000 mg/kg: no macroscopic findings were considered to be treatment related.
- females, dose 2000 mg/kg: no macroscopic findings were considered to be treatment related. Two females showed hydrometra.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met