Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
18 Feb 1988 - 03 Mar 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance isooctadecanoic acid (CAS No. 30399-84-9). In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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): Prisorine 3505
- Physical state: liquid
- Analytical purity: approx. 100 %
- Storage condition of test material: at ambient temperature in the dark
- Other: stable at storage conditions

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: range between 120 and 250 g
- Fasting period before study: overnight (prior to dosing) until approximately 3 hours after administration
- Housing: individually housed in polycarbonate cages containing purified sawdust as bedding material
- Diet (ad libitum): standard pelleted laboratory animal diet
- Water (ad libitum): tap water (via automatic nozzles)
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-60
- 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 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). Specific gravity used was 0.89 g/ml.
Doses:
2000 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, subsequently killed by CO2 and subjected to necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
no signs of systemic toxicity were observed during the 14 day observation period
Body weight:
all animals showed bodyweight gain
Gross pathology:
macroscopic examination of animals at termination did not reveal any abnormalities that were considered to be treatment related

Any other information on results incl. tables

Since no mortality occurred, the oral LD50 value for both males and females was noted as exceeding 2000 mg/kg bodyweight.

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