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Diss Factsheets

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
Study period:
not given
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 and C18-unsatd.
EC Number:
266-932-7
EC Name:
Fatty acids, C16-18 and C18-unsatd.
Cas Number:
67701-08-0
Details on test material:
Mixture of carboxylic acids (fatty acids C14-18), ceraceous, yellowish; by heating to 50 ° C quickly liquefiable

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
2 groups with 5 male and female rats each.
- Source: raiser: Winkelmann, Hannover.
- Weight at study initiation: 168g (male rats), 143g (female rats).
- Fasting period before study: 18 hours
- Housing: 5 animals per cage, separated by sexes.
- Diet: laboratory standard diet (altromin) and water water ad libitum.
The test animals were provided food (ad libitum) 3 hours after application.

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C;
- Humidity (%): 45-60%;
- Air changes (per hr): not given;
- Photoperiod (hrs dark / hrs light): 12 hours.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 25% aqueous suspension
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%;
- Amount of vehicle (if gavage): 20ml/kg.

MAXIMUM DOSE VOLUME APPLIED: 5g/kg.

DOSAGE PREPARATION (if unusual): for preparation of the suspention were used lukewarm aqua dest.. The supension was kept in movement with magnetic stirrer for applying an even mixed suspension to the test animals.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on chemical composition a less acute toxicity of the test item was expected. Because of that a limit test with a dosis of 5g/kg body weight was proved.
Doses:
5 g/kg bw
No. of animals per sex per dose:
10 animals per dose including both male and female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days;
- Frequency of observations and weighing: daily observations;
- Necropsy of survivors performed: yes;
Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
All 10 rats survived the 14 days of observation.
Clinical signs:
No symptoms of poisoning were found during the observation.
Body weight:
see table below.
Gross pathology:
No symptoms of poisoning or inflammations neither on the inner organs nor the visceral cavities were found.

Any other information on results incl. tables

Body weight average in g of each 5 test animals before and after application:

 dose

 sex

 before

application

 24 h

after application

 7 d

after application

 14 d

after application

5 g/kg

male 168.0 180.0 202.0  218.0 
 5 g/kg female 143.0 152.0 159.0

164.0

As its seen in the table the application of 5 g/kg had no impact on the body weight progress of the test animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item proves to be low acute toxicity. The LD50 can be declared for male and female rats: >5 g/kg.
Executive summary:

The carboxylic acid Edenor Ti (Edenor Talg A) was tested for acute oral toxicity according to OECD guidline 401 by limit test. It was proved to be less acute toxic at peroral application on rats (LD50 >5 g/kg bw).