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Toxicological information

Acute Toxicity: oral

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study, tested with the source substance palmitic acid (CAS 57-10-3). In accordance with 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 the study was conducted with a read-across substance.

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 16 98/100 (palmitic acid 98-100%)
- Physical state: A solid white substance, crystalline structure
- 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 183 and 137 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:
DMSO
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Purity: 99%


MAXIMUM DOSE VOLUME APPLIED: 10 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 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
Mortality:
Male rats: no mortality occurred during the 14 days observation period
Female rats: one animal died on day 12 after dosing, all other animals survived the 14 days observation period
Clinical signs:
Clinical signs appeared approximately 20 minutes after dosing including slightly diminished activity and ruffled fur. These clinical signs completely subsided within 24 hours after dosing.
Body weight:
Mean body weights prior to dosing and on days 1, 7 and 14 after dosing:
- Males: 183, 195, 214, 234 g
- Females: 137, 143, 149, 160 g
Gross pathology:
Swelling of the gastric mucosa

Applicant's summary and conclusion