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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
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:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
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:
rabbit
Strain:
other: Albino New Zealand

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact skin
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
2g/ml
Duration of treatment / exposure:
4 hours
Observation period:
the cutaneous primary irritation was evaluated on day 1 (1 hour after the removal of the pad) and on days 2, 3 and 4.
Number of animals:
Six male albino New Zealand rabbits
Details on study design:
six male albinorabbits were each administered a single dermal dose ofofitaconic acidmoistened with 0.25 ml distilled water. The test substance was applied on the intact skin for 4 hours. At the end of the treatment the semi‑occlusive dressing and gauze pad were removed and the cutaneous primary irritation was evaluated on day 1 (1 hour after the removal of the pad) and on days 2, 3 and 4.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: 24 hrs
Score:
0
Max. score:
0

Any other information on results incl. tables

There were no signs of toxicity during the observation period. No dermal response to treatment was observed in any animal throughout the observation period.

Applicant's summary and conclusion