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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 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

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

not specified

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at 5000 mg/kg bw.

Clinical signs:

other: Apart from ataxia noted after each dosing, no other signs of ill health or behavioral changes were observed during the study period.

Gross pathology:

No macroscopic significant abnormalities were noted at necropsy.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

According to CLP criteria Phytosphingosine is not classified.

Conclusions:

LD50 was considered to be >5000 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 401.

Groups of five males and five female fasted rats were given Phytosphingosine as a single dose by oral gavage at a dose level of 5000 mg/kg. The acute oral median lethal dose (LD50) of Phytosphingosine was estimated to be > 5000 mg/kg bw under the test conditions.

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