reaction product of aminoacids and palmitoyl chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.01.1999-02.02.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Details on test material:

name: SEPIFEEL ONE
batch: 98174300
aspect: white solid

Specific details on test material used for the study:

name: SEPIFEEL ONE
batch: 98174300
aspect: white solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species: Sprague-Dawley albinos
Origin: IFFA CREDO (69592 L’ARBRESLE Cedex, France)
Age: between 5 and 7 weeks old
5 males and 5 females
Acclimatization period: at least 5 days before the beginning of the study
Weight: at -1 day, individual weight was taken and they were all around the average of all animals +/- 20%
Identification: individual with picric acid
Housing: 5 by cage in polypropylen cages of 31*46*19 cm
Cages were placed in a restricted area, with a higher pressure.
Temperature: 22 +/- 2°C
Relativ humidity: 50 +/- 20%
Lighting : 12/12 hours
Feeding:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

animal were weighed the day before the administration.
5 mL/kg were administrated to the rats.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

no unscheduled death occured.

Clinical signs:

nothing to report.

Body weight:

body weight gain normal

Gross pathology:

nothing to report.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not classifled among the substances dangerous if swallowed.

Executive summary:

ASSESSMENT OF THE ACUTE ORAL TOXICITY IN RAT (LIMIT TEST) - OECD GUIDELINE 401 (24/2/1987)

The aim of the study was to assess qualitatively and quantitatively the toxic effects and the delay of appearance afler single oral administration of 2000 mg/kg body weight, of test substance suspended with distilled water, in 10 rats (5 males and 5 females).

The animals were daily observed for at least 14 days after administration and the signs of toxicily (mortality...) were noted. The test substance was classified as dangerous or not dangerous by ingestion in accordance with the EEC 67/548 Directive and its amendements.

LD0 and LD50 are superior to 2000 mg/kg.

The test substance is not classified among the substances dangerous if swallowed.