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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
Study period:
15.May.1996-29.May.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
acylation product between lauroyl chloride and amino acids
EC Number:
927-837-2
Molecular formula:
not applicable (UVCB substance)
IUPAC Name:
acylation product between lauroyl chloride and amino acids
Specific details on test material used for the study:
TEST MATERAL
Identification, reference : Matière Première Ref CS61701
Appearance: pale yellow liquid
Quantity received, packaging : 150g, 2 plastic jars
Date received: April 29, 1996
Laboratory reference: 96-1344
Analytical sheet : not supplied
Homogeneity test : not required for less than 28 days studies
Storage : at room temperature, away from the light
The test report only concerns the material to be tested

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test system
Species, strain, supplier : Albino Rat, Sprague Dawley OFA, IFFA-CREDO (69210 - L'ARBRESLE, FRANCE).
Reason for species selection : the Rat is the animal chosen by the regulatory authorities to evaluate the safety of drugs and chemicals.
Number and sex : 10, 5 males and 5 females
Age, weight: about 6 weeks, weight between 182 g and 199 g (males) and 160 g and 179g (females)
Acclimation : at least 5 days
Housing, diet: 5 animals by sex in polypropylene cages (310 x 465 x 190) in accordance with the requirements of the 86/609/EEC guideline. Complete pelleted rat maintenance diet UAR A04-10 (91360-EPINAYSURORGE, FRANCE).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
Animals have been fasted prior to substance administration by withholding food overnight. They receive by gavage, according to the bodyweight, the product diluted in distilled water at the dose of 5000 mg/kg under a volume of 10 ml/kg.
Reason for route of administration : Oral gavage is the route of choice for estimating potential adverse effects resulting from accidental oral ingestion.
Doses:
5000 mg/kg under a volume of 10 ml/kg
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:
a clinical observation is carried out at least once a day in order to evaluate the general appearance, the behaviour and vegetative functions of the animals. An individual clinical observation is realized one hour after treatment. The continuous observations during the five following hours are renewed each following day.
body weight are taken just prior to the test animal administration (D1) and again 3, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
At termination of the 14 observation days, the reats are sacrificed after barbituric anaesthesia then autopsied. All abnormalities are recorded. No tissue is saved.

Results and discussion

Preliminary study:
no
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
No modification in the aspect, behaviour or vegetative functions is observed in the animals, 1 hour after the treatment (table 1) or during the 5 following hours. The daily examinations which are repeated during next 13 consecutive days, fail to reveal any alteration in the general appearance and behaviour of the animals.
Body weight:
The individual growth weight of all the animals (males and females) is normal and regular.
The mean weight gain 14 days after the treatment appears satisfactory for this animal species.
Other findings:
Post mortem examinations:
The gross necropsy of the animals 14 days after the treatment does not show any visible organic or tissular lesions leading us to suspect a possible systemic toxicity of the product.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted, the oral LD0 of the test material Matiere Première Ref. CS61701 in male and female Rat is higher than 5000 mg/kg.
According to the 67/548/EEC directive, the test substance is unclassified if swallowed.
Executive summary:

The single oral administration of the substance Matière Première Ref. CS61701 in the male and female Rat at the dose of 5000 mg/kg:

- does not cause any death, - has no significant toxic effect on the animals' behaviour or vegetative functions, - does not modify their weight growth, - does not cause any gross lesions visible at autopsy.

Under the experimental conditions adopted, oral LD0 of the test substance is higher than 5000 mg/kg in the rat.

According to the 67/548/EEC directive, the test substance is unclassified if swallowed.