Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 - 29 September 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP Study conducted according to OECD Guideline 401 with deviations: purity of test substance not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
yes
Remarks:
purity of test substance not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid
Remarks:
paste opac
Details on test material:
- Physical state: Paste opac
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG.
- Age at study initiation: 8 weeks
- Weight at study initiation: 251 ± 6.4 g (males); 196 ± 10.5 g (females)
- Fasting period before study: Animals were fasted overnight prior to dosing until 3-4 hours after administration of the test substance.
- Housing: Animals were individually housed in polycarbonate cages containing purified sawdust as bedding material.
- Diet: Standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, The Netherlands), ad libitum
- Water: Tap-water (via automatic nozzles), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 °C
- Humidity: 60-90 %
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: 15 - 29 September 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
reverse osmosis wate
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION: The test substance was suspended in reverse osmosis water and administered once only by gavage using a stainless steel stomach cannula attached to a disposable plastic syringe.
Doses:
2000 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: Cage-side observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Individual body weights were measured weekly.
- Necropsy of survivors performed: Yes; at the end of the study (day 14) all animals were killed by CO2-asphyxiation and subjected to necropsy.
Statistics:
None

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 was observed.
Clinical signs:
No signs of systemic toxicity were observed during the 14-day observation period.
Body weight:
All animals showed body weight gain during the study period.
Gross pathology:
Macroscopic examination of all animals at the end of the study revealed no gross abnormalities.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 of the test substance is higher than 2000 mg/kg bw in rats therefore it is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study performed according to OECD Guideline No. 401 and in compliance with GLP, groups (5/sex/dose) of Wistar rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.  

No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. All animals showed body weight gain during the study period. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Oral LD50 Combined > 2000 mg/kg bw.

 

Under the test conditions, the test substance is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.