Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-599-6 | CAS number: 97-65-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
- No. of animals per dose:
- 20
- Details on study design:
- The sensitisation potential of itaconic acid was evaluated in guinea pig according to the maximisation method of Magnusson and Kligman.
Based on the preliminary study, the following dose levels were selected: 0.1 ml of the test substance was administered by intradermal route at a concentration of 1% in NaCl at 0.9% (day 1), 500 mg of the test substance as such was applied topically (day 8) and at challenge (day 20), 500 mg of the test substance as such was applied topically. Twenty test and ten control guinea pigs were used in this study. - Challenge controls:
- 10
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other:
- Dose level:
- 500mg
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- No clinical signs and no deaths
- Remarks on result:
- other: Reading: other:. Dose level: 500mg. No with. + reactions: 0.0. Total no. in groups: 30.0. Clinical observations: No clinical signs and no deaths.
Any other information on results incl. tables
No clinical signs and no deaths were observed throughout the study. At challenge, itaconic acid did not produced any cutaneous reaction 24 and 48 hours after removal of the dressing.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
