Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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.