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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 1995-01-03 and 1995-01-19
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:
1995
Report date:
1995

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 4 animals tested
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Ceramide IIIB
IUPAC Name:
Ceramide IIIB
Test material form:
solid: particulate/powder
Details on test material:
Ceramide IIIB

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:
2 males and 2 females
Control animals:
not specified
Details on study design:
One group of Wistar rats, consisting of two males and two 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:
None described.

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 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, 2 male and 2 female Wistar strain rats were given a single dose of Ceramide IIIB 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. No clinical signs were observed during the study period and no macroscopic toxicological significant abnormalities were noted at necropsy at the end of the experimental period.

Dermal LD50 (rat) > 2000 mg/kg bw