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EC number: 252-021-1 | CAS number: 34432-92-3
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.10.2012 – 29.10.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Guideline:
- other: OECD Test Guideline No. 404 - Acute Dermal Irritation/Corrosion. Adopted 24th April 2002
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
Weight at study initiation: 3.9-4.2 kg
Housing: individually in cages without bedding in conventional animal room
Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy))
Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
Temperature (°C): 17 - 23°C, permanently monitored
Humidity (%): 30 – 70 %, permanently monitored
Air changes (per hr): approximately 15 air changes per hour
Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES:
Animal supply: 17. 10. 2012
Experimental part of study: 22.10. – 29. 10. 2012 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape - Spofaplast
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to the grading system given in Method B.4 Acute toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritant / corrosive response data:
- Results of Clinical Observation
There was no evidence of a corrosive effect on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
No histopathology was performed. - Other effects:
- Very slight erythema was observed in 1 hour after exposure only in rabbit No. 7. No skin reaction was observed in the other two rabbits. At 24, 48 and 72 hours after exposure no sign of erythema and oedema were recorded.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, Solvent Yellow 124, was tested for acute dermal irritation/corrosion.
Three rabbits were exposed to 0.5 mg of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at the 1, 24, 48 and 72 hours after exposure.
Very slight erythema was observed in 1 hour after exposure only in rabbit No. 7. No skin reaction was observed in the other two rabbits. At 24, 48 and 72 hours after exposure no sign of erythema and oedema were recorded. No evidence of a corrosive effect or symptoms of irritation were observed during all study on the skin of all animals.
No skin irritation was caused by 4-hour exposure of rabbits to Solvent Yellow 124. - Executive summary:
The test substance, Solvent Yellow 124, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test. Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
Three rabbits were exposed to 0.5 mg of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.
At first the test substance was applied on the skin of one rabbit (test animal No. 7). Rabbit
No. 7 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance.
In confirmatory test, two others rabbits (rabbit No. 8 and No. 9) were used with 4-hour exposition period.
Very slight erythema was observed in 1 hour after exposure only in rabbit No. 7. At 24, 48 and 72 hours after exposure no sign of erythema and oedema were recorded and no evidence of a corrosive effect or symptoms of irritation were observed on the skin of all animals.
No skin irritation was caused by 4-hour exposure of rabbits to Solvent Yellow 124.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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