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EC number: 410-070-8 | CAS number: 141880-36-6 ACID RED HT 3728; ERIONYL RED HT 3728
- 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
- Study period:
- 04 August 1992 to 11 February 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- code number: FAT 45155/B
purity: 60 - 70 %
physical appearance: powder, dark red
storage: room temperature, keep dark
expiration date: May. 15, 1997
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The guinea pigs were recognized by the international guideline as the recommended test system.
The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group.
- Breeder: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Date of acclimatisation: August 12, 1992
- Weight at study initiation: 301-396 g
- Housing: individually in Macrolon cages
- Diet : Pelleted standard Kliba 342, Batch 24/85 guinea pig breeding/ maintenance diet ad libitum.
- Water: fresh water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%):30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): a 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 %
- Day(s)/duration:
- Week 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30 %; patch 2x4 cm; approx. 0.4 g paste per patch
- Day(s)/duration:
- Week 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30 %; 2x2 cm; approx. 0.2 g paste per patch
- Day(s)/duration:
- Week 5
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
- Details on study design:
- See materials and methods
- Challenge controls:
- Vehicle: Vaseline
- Positive control substance(s):
- yes
- Remarks:
- Potassium dichronate
Results and discussion
- Positive control results:
- 90 % of the animals were positive after treatment with the reference substance at the concentration of 1 % in vaseline. Therefore reference article Potassium dichronate should be considered to be an extreme sensitizer under the test conditions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Key result
- Reading:
- other:
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- See remarks on result
- Remarks on result:
- other: See remarks
- Remarks:
- Skin sensitizer based on histopathological examination: all treated animals at the application-site changes characteristic for contact dermatitis, including spongiosis, acanthosis, hyper- and parakeratosis, pustules, congestion and lymphohistiocytic infiltration
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythema and edema and histopathological examination
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythema and edema and histopathological examination
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 % in Vaseline
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- erythema and edema
- Remarks on result:
- other: Potassium dichronate
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 % in Vaseline
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema and edema
- Remarks on result:
- other: Potassium dichronate
Any other information on results incl. tables
The evaluation of a possible skin erythema was impeded by the red-coloured test article which could not be washed off entirely. Therefore, histopathological examination of the application and remote site from all animals was carried out at the end of this study. Only results from histopathological examination were used for classification of FAT 45155/B according to Magnusson and Kligman. Thus, under the experimental conditions employed, 100 % of the animals of the test group were sensitised by FAT 45155/B.
Pathology
Microscopical findings
When compared to the tissues from control animals and to the "remote site" in treated animals, the application site of skin from all animals treated with the test article showed prominent changes compatible with contact dermatitis. This finding was characterized by following features: a minimal to moderate spongiosis (without prominent presence of blisters-formation), a minimal to moderate congestion in the upper dermis, a minimal to marked acanthosis with minimal to moderate hyper- and parakeratosis and a minimal to marked lymphohistiocytic infiltration predominantly in the upper dermis, in some animals with invasion in to the epidermis. Two animals showed additionally pustules with cell debris in the epidermis. In some animals, there was a minimal lymphohistocytic infiltration also in the subcutaneous tissue, mostly located around blood vessels. One animal (No. 3, treated group) showed similar, minimal, focal changes at the remote site. Since this focus was localized at the margin of the sample, it could be assumed, that the test article spread beyond the testing site during the application. A minimal lymphocytic infiltration, in some cases associated with admixture of eosinophils or lymphohistiocytic infiltrations of the subcutaneous tissue, occurred at the remote site in nearly all control and treated animals. This is attributed to the application procedure (fur clipping) and not to an effect of the test article. Irritative changes occurred neither at the application- nor at the remote site.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- FAT 45155/B is considered as skin sensitiser.
- Executive summary:
A skin sensitization study was performed to assess the allergenic potential of FAT 45155/B in albino guinea pigs. The study was carried out according to OECD guideline 406 under GLP-compliance.
The induction was a two-stage operation. First (at week 1 with 1 % test article concentration in physiological saline), intradermal injections (into the neck region); second (at week 2 with 30 % test article concentration in vaseline), closed patch exposure over the injection sites one week later. During weeks 3 and 4 no treatments were performed. The animals were challenged at week 5 with 30 % test article concentration in Vaseline (w/w). A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum sub irritant concentration of the test article in adjuvant treated animals. 24 and 48 hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. The evaluation of a possible skin erythema was impeded by the red-coloured test article which could not be washed off entirely. At the end of the test period all controls and treated animals were bled under ether anesthesia and from each animal samples of skin (the application- and the remote site) were taken and preserved in neutral buffered 4 % formalin. Each sample was trimmed longitudinally to hair direction, embedded in paraplast, sectioned at 3-5 microns, stained with hematoxylin and eosin, and subjected to a microscopical examination. The evaluation of a possible skin erythema was impeded by the red-coloured test article which could not be washed off entirely. Therefore, histopathological examination of the application and remote site from all animals was carried out at the end of this study. Only results from histopathological examination were used for classification of FAT 45155/B according to Magnusson and Kligman. Macroscopical evaluation of a possible skin erythema was impeded by the red-coloured test article. Therefore histopathological examination of the skin (application and remote site) of all animals was carried out at the end of this study. Microscopical examination revealed in all treated animals at the application-site changes characteristic for contact dermatitis, including spongiosis, acanthosis, hyper- and parakeratosis, pustules, congestion and lymphohistiocytic infiltration. Under the experimental conditions employed, 100 % of the animals of the test group were sensitised by FAT 45155/B. Based on the study results, FAT 45155/B is, therefore, classified as an extreme sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
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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