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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:
weight of evidence
Study period:
17 September - 2 October 1990
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:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
no analytical purity reported
GLP compliance:
yes (incl. QA statement)
Remarks:
Bezirksregierung, Lüneburg, Germany
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
130905-60-1
EC Number:
603-445-4
Cas Number:
130905-60-1
IUPAC Name:
130905-60-1

Test animals

Species:
rat
Strain:
other: Crl.: (WI) BR - Wistar, white
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Weight at study initiation: 268 – 293 g (males); 208 – 228 g (females)
- Fasting period before study: animals were fasted from 16 h before until 3 - 4 h after administration of the test article
- Housing: 5 animals of the same sex per cage in Macrolon cages type III
- Diet: Ssnif-R Alleindiät, pellets
- Water: drinking water supplied in drinking bottles, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 – 85 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined for clinical signs at the following time point after administration: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14. Individual body weights were determined weekly: on days 0 (before treatment), 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, grosspathology
Statistics:
LD 50 values were calculated according to Finney D. Y., Probit Analysis, 3rd edition, Cambridge, 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of 14-day observation period
Gross pathology:
Necropsy examination revealed no substance-related findings

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: not classified