Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Itaconic acid
EC Number:
202-599-6
EC Name:
Itaconic acid
Cas Number:
97-65-4
Molecular formula:
C5H6O4
IUPAC Name:
2-methylidenebutanedioic acid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: gum arabic
Duration of exposure:
15 day
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
A group of ten rats 5 males and 5 females was given a single dermal application of itaconic acid formulated in gum arabic, at a dose level of 2000 mg/kg bodyweight. All surviving animals were sacrificed and examined macroscopically on day 15, the end of the observation period.

Results and discussion

Effect levels
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
no

Any other information on results incl. tables

There were no death and no sign of systemic reaction to treatment. Bodyweight gains were normal and no abnormalities were recorded at the macroscopic examination on day 15.

Applicant's summary and conclusion