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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 guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
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:
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

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.

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