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Diss Factsheets
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EC number: 228-906-3 | CAS number: 6372-81-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- according to OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- EC Number:
- 225-935-3
- EC Name:
- Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- Cas Number:
- 5160-02-1
- Molecular formula:
- C17H13ClN2O4S.1/2Ba
- IUPAC Name:
- barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Animal specifics: New Zealand White , conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (fully air-conditioned)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 mL to moisten the test item
- Lot/batch no. (if required): polyethylene glycol 400, Ch-B 2322 , Riedel de Haen AG - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
approximately 24 h before treatment the test site was clipped free of hair (25 cm2).
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG), fixed with a semiocclusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
as in EU Method B.4, assessed approximately 30 - 60 min, 24, 48, and 72 h after the removal of the test item
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Animal 1: Erythema grade 1 observed at 30-60 min reading was fully reversible within 24 hours. Animal 2 & 3: Reversibility not relevant since no effects occured.
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritant / corrosive response data:
- Scores (oedema or erythema) were 0 at 24, 48 and 72 h after removal of dressing in all animals
- Other effects:
- light-red staining produced by the color of the test item was present in all animals at all reading time points.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
The application of the test item to the skin resulted in slight, early-onset and transient erythema in one animal. This effect was reversible and no longer evident 24 hours after treatment. Light-red staining of the treated skin (caused by the color of the test item) was noted in all animals throughout the whole study. Mean scores of all animals for edema and erythema were 0. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Therefore, the test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008.
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