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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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
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): Edenor C 12 98/100, SIS-Nr 611 (lauric acid 98 - 100 %)
- Physical state: A solid white substance (tallow-like)
- Analytical purity: 98 - 100 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Supplied by Winkelmann, Hannover, Germany
- Weight at study initiation: Mean body weights of male and female rats were 164 and 133 g, respectively
- Fasting period before study: 18 hours prior to dosing (feeding only)
- Housing: Same sex-groups of five Wistar rats were housed in type III Makrolon-cages containing soft wood granulated material
- Diet: A standard laboratory animal diet (Altromin for rats)
- Water: ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw


MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed immediately after dosing and 1, 4 and 24 hours after dosing, then once every 24 hours thereafter for the rest of the observation period. Individual bodyweights were measured immediately prior to dosing and 24 hours after dosing as well as 7 and 14 days after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
Clinical signs appeared approximately 20 minutes after dosing including slightly ruffled fur, which subsided completely within 24 hours. No other effects noted.
Body weight:
Mean body weights prior to dosing and on days 1, 7 and 14 after dosing:
- Males: 164, 176, 195, 218 g
- Females: 133, 142, 151, 160 g
Gross pathology:
Slight reddening of the gastric mucosa was noted. No other effects noted.

Applicant's summary and conclusion