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Administrative data

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to
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 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:
Apart from ataxia noted after each dosing, no other signs of ill health or behavioral changes were observed during the study period.
Body weight:
not specified
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).