2-hydroxy-N-((2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl)octadecanamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April-1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

only basic data given; experimental period only 8 days; only 4 animals tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

experimental period 8 days only, only 6 animals tested

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Ceramide VI

IUPAC Name:

Ceramide VI

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Ceramide VI

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

no information available

Administration / exposure

Type of coverage:

not specified

Vehicle:

propylene glycol

Details on dermal exposure:

no information given

Duration of exposure:

no information given

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 males and 3 females

Control animals:

not specified

Details on study design:

One group of Wistar rats, consisting of three males and three females, received a single dermal application of the test substance suspended in propylene glycol at a dose level of 2000 mg/kg body weight (dose volume 10 mL/kg body weight).
Animals were subjected to daily observations and determination of body weight at start and termination.
Macroscopic examination of the animals was performed at the end of the experimental period (day 8).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No abnormalities were found at macroscopic examination of the animals.

Other findings:

Focal erythma was noted in one animal, on day 2. Red staining of the snout, head or neck was noted in three animals, between days 1 and 4.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to this study, the dermal LD50 value of the test substance Ceramide VI for both males and females was considered to exceed 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study similar to OECD guideline 402, 3 male and 3 female Wistar strain rats were given a single dose of Ceramide VI suspended in propylene glycol at a dose level of 2000 mg/kg body weight (dose volume 10 mL/kg body weight). Animals were subjected to daily observations and determination of body weight at start and termination. Macroscopic examination of the animals was performed at the end of the experimental period (day 8).

No animal died. No effect on body weight gain was observed. Focal erythma was noted in one animal, on day 2. Red staining of the snout, head or neck was noted in three animals, between days 1 and 4. No macroscopic toxicological significant abnormalities were noted at necropsy at the end of the experimental period.

The dermal LD50 value for Ceramide VI for both male and female rats was considered to exceed 2000 mg/kg body weight.

Dermal LD₅₀ (rat) > 2000 mg/kg bw