2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June-2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

only basic data given; experimental period 8 days; three femals and three males

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

three female and three male rats, experimental period only 8 days

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide

EC Number:

855-895-8

Cas Number:

212908-67-3

Molecular formula:

C27H47NO5

IUPAC Name:

2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide

Test material form:

solid: particulate/powder

Details on test material:

Batch: K928/99/1/1/39
Purity: 97.4%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

no information available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

Dose volume: 10 mL/kg bw

Doses:

2000 mg/kg body weight (dose volume 10 ml/kg body weight)

No. of animals per sex per dose:

3 males, 3 females

Control animals:

no

Details on study design:

Animals were subjected to daily observations and determination of body weight at start and termination. Macroscopic examination of the animals was performee at the end of the experimental period (day 8).

Results and discussion

Preliminary study:

Not reported.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality occurred.

Clinical signs:

other: Lethargy was noted in one male on day 1.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination.

Other findings:

none reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this acute oral toxicity study, the oral LD50 value of the test item in rats of either sex was exceeding 2000 mg/kg bodyweight.

Executive summary:

In an acute oral toxicity study similar to OECD guideline 401, 3 male and 3 female Wistar strain rats were given a single oral dose of Salicyloyl Phytosphingosine in propylene glycol by gavage at a dose of 2000 mg/kg bodyweight. The animals were observed daily for a period of 8 days. Body weight gain was determined.

No animal died. Apart from lethargy noted in one male an day 1, no other signs of ill health or behavioural changes were observed during the study period and no macroscopic toxicological significant abnormalities were noted at necropsy at the end of the experimental period.

Oral LD₅₀ (rat) > 2000 mg/kg bw