A mixture of: (9-cis,12-cis)-2-hydroxy-3-(octadeca-9,12-dienoylamino)propyl hexadecanoate; (9-cis)-2-hydroxy-3-(octadeca-9-enoylamino)propylhexadecanoate ethyl hexadecanoate;

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

the temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: whitish scales

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% methylcellulose in purified water

Details on oral exposure:

Single administration on day 1, followed by a 14 day observation period.

Doses:

2000 mg/kg (or 10 mL/kg)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Preliminary test : 3 female rats with 2000 mg/kg
Principal test : as no deaths occured, the results were the confirmed in 3 other female with 2000 mg/kg

Results and discussion

Preliminary study:

No deaths occured

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels : none

Body weight:

A reduced body weight gain was noted in 2/6 female during the second week of the study

Gross pathology:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality and no clinical signs were noted during the study. No apparent abnormalities were observed in any animal.
Under experimental conditions, the oral DL50 of the test item was higher than 2000 mg/kg in rats.

Executive summary:

Acute toxicity of omega 6 ceramide was evaluated according to OCDE 423 guideline. The study was conducted in compliance with the principles of Good Laboratory Practice regulations. No mortality and no clinical signs were noted during the study. No apparent abnormalities were observed in any animal. Under experimental conditions, the oral DL50 of the test item was higher than 2000 mg/kg in rats. According to the classification criteria concerning the potential toxicity by oral route, the test item should not be classified.