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

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 5000 mg/kg (rat)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

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

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A reliable key study is available investigating acute oral toxicity of Phytosphingosine in rats according to OECD 401. The rats were exposed to a single oral dose of the test item (5000 mg/kg) and observed during post exposure. No mortality, significant clinical signs or macroscopic changes were found in rats exposed to the test item (5000 mg/kg). LD50 is therefore reported as > 5000 mg/kg.

Justification for classification or non-classification

The submission substance does not need to be classified for acute toxicity according to the criteria set out in the CLP Regulation. No mortality, significant clinical signs or macroscopic changes were found in rats exposed to the test item (5000 mg/kg).