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EC number: 259-224-4 | CAS number: 54553-90-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Title:
- No information
- Author:
- Anonymous
- Year:
- 2 007
- Bibliographic source:
- IUCLID4 data set, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An in vivo non-LLNA test was already available.
Test material
- Reference substance name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
- EC Number:
- 259-224-4
- EC Name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
- Cas Number:
- 54553-90-1
- Molecular formula:
- C10H6O8.C9H10N2
- IUPAC Name:
- benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st: Induction 60 % occlusive epicutaneous
2nd: Induction 60 % occlusive epicutaneous
3rd: Induction 60 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st: Induction 60 % occlusive epicutaneous
2nd: Induction 60 % occlusive epicutaneous
3rd: Induction 60 % occlusive epicutaneous
- No. of animals per dose:
- 20 animals for test
10 animals for control - Details on study design:
- TEST ANIMALS:
- Strain: Dunkin-Hartley, Pirbright White, Hsd/Win:DH (SPF)
- Sex: female
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Age: healthy young adults
- Weight at study initiation: 373 g (mean test); 372 g (mean control)
- Controls: 10 animals; treatment: vehicle
ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction:
applied quantity approximately 0.5 g of the homogeneous preparation test
substance / vehicle
- Induction schedule: 3 identical inductions on days 0, 7, and 14:
6 hour occlusive patch (left side), concentration 60 %; then removal of
residual test material
assessment 30 hours after each administration
- Challenge schedule: day 28
two 6 hour occlusive patches (right side), one with test material and one
with vehicle only
subsequent removal of residual test material
assessments 30 and 54 hours after administration
- Concentrations used for challenge: 60 %
- Positive control:
2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)
Magnusson-Kligman maximization test with 10 test and 10 control animals
Intracutaneous induction with 2.5 % in corn oil
Occlusive epicutaneous induction with 50 % in corn oil
Occlusive epicutaneous challenge with 50 % in corn oil
EXAMINATIONS
- Grading system: as usual for skin irritation, 0-8 scores possible
- Pilot study: determination of slightly and not skin irritating concentrations
dermal concentrations: 10; 20; 40; 60 % w/w
3 animals each with 4 different concentrations at different sites
6 hour occlusive patch test followed by removal of residual test material
assessment of dermal reactions 30 and 54 hours after administration
- Additional (and identical except for increased body weights) pilot study
during week 4; reason: Increase in body weight might cause differences in
skin sensitivity - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: None of the applied test substance
concentrations caused primary skin irritation in any of the two pilot studies
30 or 54 hours after administration.
RESULTS OF TEST
- Sensitization reaction: No signs of skin irritation were observed in the
application areas of test and control animals 30 and 54 hours after
administration.
- Clinical signs: No treatment related signs of systemic toxicity were
observed.
1st, 2nd, and 3rd induction: No signs of skin irritation were observed in the
application areas of test and control animals 30 hours after administration.
- Positive control: 10/10 test animals positive, no control animal positive
- Other:
A preparation of 70 % test substance in vehicle could not be mixed
satisfactorily.
The overall mean body weight increase of 176 g (test group) / 171 g
(control group) is normal: no treatment related effect.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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