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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-348-1 | CAS number: 2421-28-5
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)
- Rationale for reliability incl. deficiencies:
- other: experimental result in a reliable toxicology laboratory, preceding establishment of guideline and GLP. Documentation is limited.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no notation of adjuvant; challenge exposure was administered via intradermal injection.
- GLP compliance:
- no
- Remarks:
- precedes establishment of GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The described guinea pig sensitisation test similar to OECD 406 was conducted in 1977 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the non-LLNA test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
Test material
- Reference substance name:
- Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
- EC Number:
- 219-348-1
- EC Name:
- Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
- Cas Number:
- 2421-28-5
- Molecular formula:
- C17H6O7
- IUPAC Name:
- 5-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl)-1,3-dihydro-2-benzofuran-1,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.4 mg over 8 administrations, 0.1% solution (w/v) of BTDA crystalline powder in normal saline.
- Day(s)/duration:
- every other day
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.4 mg over 8 administrations, 0.1% solution (w/v) of BTDA crystalline powder in normal saline.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 36
- Details on study design:
- The study was undertaken with unwashed, commercial grade BTDA, and also with BTDA washed with acetone. Eighteen guinea pigs received intradermal injections (0.05 ml of 0.1% BTDA unwashed w/v in saline, without adjuvant) every other day for 8 injections. They were allowed a rest period of 3 weeks, after which they received a single challenge dose by intradermal injection. The experiment was repeated with BTDA purified by washing in acetone.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- other: unwashed BTDA
- Dose level:
- 0.1%
- No. with + reactions:
- 15
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- other: acetone-washed BTDA
- Dose level:
- 0.1%
- No. with + reactions:
- 17
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- 1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was purified by washing in acetone, and commercial-grade (unwashed) and purified BTDA was tested in a non-LLNA skin sensitisation test in guinea pigs. Both the unwashed and washed substance were found to be sensitising in the guinea pig.
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.
