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EC number: 245-728-1 | CAS number: 23552-74-1
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ESTOFIL BLUE S-RLS; C41B
- IUPAC Name:
- ESTOFIL BLUE S-RLS; C41B
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 Fuellinsdorf I Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 3.0 kg
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libintum
- Acclimation period: Four days under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 40-70
- Air changes (per hr): > 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: PEG 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg / site
- Concentration (if solution): moistened with vehicle - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 100 cm²
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): luke- warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: OECD TG 404 (1984)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test material showed a primary irritation score of 0.7 when applied to intact rabbit skin.
Local signs (mean 1 hour to 7 day) consisted of grade 0.4 erythema and grade 0.0 edema. They were reversible within 7 days.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. - Other effects:
- In the area of application a blue staining of the treated skin by the test article (blue pigment) was observed.
The body weight gains of all rabbits were similar. No acute toxic symptoms were observed in the animals during the test period, and
no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
TREATMENT
Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
On test day 1, 0.5 g of the test article (The test article was moistened with polyethylene glycol )
w
as applied to the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours.Four hours after the application, the dressing was removed and the skin was flushed with 1ukewarm tap water. The skin reaction was assessed according to the OECD Guideline for Testing of Chemicals 404. The skin reaction was assessed at 1, 24, 48 and 72 hours and at 7 days after the removal of the dressing, gauze patch and test article.
IRRITATION / CORROSION
The test material showed a primary irritation score of 0.7 when applied to intact rabbit skin. Local signs (mean;1 hour to 7 day) consisted of grade 0.4 erythema and grade 0.0 edema.
They were reversible until day 7.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other Findings:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
The body weight gain of all rabbits was similar.
In the area of application a blue staining of the treated skin by pigment or coloring of the test article was observed.
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