Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Jan - 09 Feb 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(dose volume exceeding limit of 10 mL/kg bw)
GLP compliance:
not specified
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): sorbitan tristearate
- Physical state: wax-like particles with a slightly rancid odour
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 155 g (mean females), 174 g (mean males)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION (if unusual): The test substance was suspended in a 2% carboxymethyl cellulose solution; stirring and warming was necessary for dosage preparation.
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: body weights were recorded prior to application and 48 h, 1 week and 2 weeks after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Statistical analysis was performed following the method of Litchfield and Wilcoxon.

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 occured during the test period
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period
Body weight:
No effect on body weight was noted (see table 1)
Gross pathology:
Necropsy and gross pathology revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Group mean body weight development of rats dosed orally with [test compound].

Sex

Dose (mg/kg)

Bodyweight (g) at

Dosing

48 h

1 week

2 weeks

2000

174

191

210

236

2000

155

163

166

177

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified