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EC number: 259-226-5 | CAS number: 54553-91-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA was not adopted as a OECD test guideline at the time of study conduct
Test material
- Reference substance name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
- EC Number:
- 259-226-5
- EC Name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
- Cas Number:
- 54553-91-2
- Molecular formula:
- C10H6O8.2C9H10N2
- IUPAC Name:
- benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin Hartley, Pirbright White Hsd/Win:DH [SPF]
- Sex: female
- Source: Harlan Winkelmann GmbH, D-33176 Borchen
- Age: healthy young adults
- Weight at study initiation: 383 g (mean test); 364 g (mean control)
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st: Induction 500 mg on Day 0 for 6 h
2nd: Induction 500 mg on Day 7 for 6 h
3rd: Induction 500 mg on Day 15 for 6 h - Day(s)/duration:
- Day 0, 7 and 14 / 6h treatment each
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st challange: 500 mg
- Day(s)/duration:
- Day 30 / 6 h treatment, assessment 30 and 54 h after administration
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals for test
10 animals for control - Details on study design:
- 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 50 %; 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: 50 %
- Positive control:
2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)
Magnusson-Kligman maximization test with 10 test and 2 x 5 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: 5; 10; 30; 50 % 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
- Positive control results:
- Positive control: 10/10 test animals positive
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity were detected during the observation period.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity were detected during the observation period.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 0 mg
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were detected during the observation period.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 0 mg
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were detected during the observation period.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50 % in corn oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 50 % in corn oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
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. Higher concentrations were not homogeneously miscible with vehicle.
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 signs of systemic toxicity were detected during the observation period.
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
The overall mean body weight increase of 194 g (test group) / 188 g (control group) is normal: no treatment related effect.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available study according to OECD 406, the Test Item is considered as not skin sensitizing.
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.
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