1,3,4-Octadecanetriol, 2-amino-, sulfate (2:1) (salt), D-ribo- (8CI)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

-

EC Number:

439-210-6

EC Name:

-

Cas Number:

554-62-1

Molecular formula:

C18H39NO3

IUPAC Name:

(2S,3S,4R)-2-aminooctadecane-1,3,4-triol

Test material form:

solid

Remarks:

white powder

Test animals

Species:

other: Rat, Wistar strain Crl:(WI) BR

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Corn oil.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Details on study design:

- Duration of observation period following administration: not specified
- Frequency of observations and weighing: Animals were subjected to daily observations and weekly determination of body weight.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Statistics:

not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: All males showed lethargy on day 1. No clinical signs of systemic toxicity were noted in females.

Gross pathology:

Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 was considered to be > 2000 mg/kg bw, when rats were treated with Phytosphingosine orally.

Executive summary:

The acute oral toxicity of Phytosphingosine was assessed in rats following a single administration of Phytosphingosine. The study was performed in compliance with OECD guideline 423 (Acute Toxic Class Method).

Groups of three males and three female fasted rats were given Phytosphingosine as a single dose by oral gavage at a dose level of 2000 mg/kg. The acute oral median lethal dose (LD50) of Phytosphingosine was estimated to be > 2000 mg/kg bw under the test conditions.

The study was considered reliable and adequate for hazard assessment of human health.