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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pripol 1009/Dimer acid
- Physical state: liquid
- Analytical purity: approx. 99 %

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: 9 weeks
- Weight at study initiation: females 200 g / males 300 g (day of dosing)
- Fasting period before study: fasted overnight until approximately 3 hours after administration of the test substance
- Housing: Animals were individually housed in polycarbonate cages containing purified sawdust (Woody Clean supplied by Broekman Institue, Someren, The Netherlands) as bedding material.
- Diet (ad libitum): standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, The Netherlands)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Test article was administered once only by gavage using a stainless steel stomach cannula attached to a disposable plastic syringe. The dose volume (ml/kg bodyweight) used was calculated as follows: dose (g/kg bodyweight) / specific gravity (g/ml). The specific gravity used was 0.95 g/ml.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
Clinical observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration.
Individual bodyweights were measured weekly.
At the end of the study (day 14), all animals were anesthetized by CO2/O2 inhalation and subsequently killed by CO2 and subjected to necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no mortality occurred
Mortality:
no mortality occurred
Clinical signs:
No signs of systemic toxicity were observed during the 14 day observation period.
Body weight:
All animals showed normal body weight gain.
Gross pathology:
Macroscopic examination of animals at termination of the study did not reveal any abnormalities that were considered to be treatment related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification