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EC number: 250-792-9 | CAS number: 31765-95-4
- 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 sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not reported
- Specific details on test material used for the study:
- Name: Saturn Grey LCGCAS: 31765-95-4Batch No.: 8010/2008Appearance: black powderStorage: dark dry room, closed container, at laboratory temperatureExpiration date: February 2018
- Species:
- guinea pig
- Strain:
- other: BFA
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: monitored breeding farm (RČH CZ 21760039, Luboš Sobota, U nádraží 901, Městec Králové, Czech Republic)- Females (if applicable) nulliparous and non-pregnant: yes- Age at study initiation: not listed- Weight at study initiation: 295 - 453 g- Housing: monitored conditions, microbiologically defined background, shavings of soft wood- Diet (e.g. ad libitum): pelleted standard diet for guinea pigs ad libitum- Water (e.g. ad libitum): drinking tap water ad libitum (supplemented by ascorbic acid)- Acclimation period: 5 days- Indication of any skin lesions: no signs of disease were observed at clinical check-inENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3°C (permanently monitored)- Humidity (%): 30 - 70 %- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction – intradermal injections: 10% suspension in physiological salineInduction – topical application: 10% suspension in physiological salineChallenge – topical application: 5% suspension in physiological saline
- Day(s)/duration:
- Day 0 - inntradermal injection Day 6 - topical application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % (w/w)
- Day(s)/duration:
- 20th day
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals (M+F) in treatment group (10 animals (M+F) in control group)
- Details on study design:
- DOSE LEVELS: - Induction – intradermal injections: 10% suspension in physiological saline - Induction – topical application: 10% suspension in physiological saline - Challenge – topical application: 5% suspension in physiological salineAPPLICATION:Day 0, treated group:Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of midline. - Injection 1: 1:1 (v/v) mixture Freunds Complete Adjuvant (FCA) and physiological saline - Injection 2: 10% suspension of the test substance in physiological saline - Injection 3: 10% suspension of the test substance in 1:1 1 (v/v) mixture FCA / physiological salineDay 0, control group:Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of midline. - Injection 1: 1:1 (v/v) mixture Freunds Complete Adjuvant (FCA) and physiological saline - Injection 2: 10% physiological saline - Injection 3: 10% physiological saline in 1:1 1 (v/v) mixture FCA / physiological salineDay 6, treated group:24 hours before application (day 5) the test area was cleared of hair. A filter paper (2×4 cm) with 10% suspension of the test substance in physiological saline was applied to the test area and held in contact by an occlusive dressing for 48 hours.Day 6, control group:24 hours before application (day 5) the test area was cleared of hair. A filter paper (2×4 cm) with physiological saline only was applied in a similar manner to the test area and held in contact by an occlusive dressing for 48 hours.Day 20, treated and control group:The flanks of treated and control animals were cleared of hair before application. In treated and control animals a filter paper (2×2 cm) saturated with 5% suspension of the test substance in physiological saline was applied on a right flank of the animals and a filter paper (2×2 cm) with physiological saline only was applied on a left flank of the animals. The patches were hold in contact by an occlusive dressing for 24 hours.Day 22–23, treated and control group:Approximately 21 hours after removing patch the challenge area were cleaned and shaved. Approximately 3 hours later (cca 48 hours from the start of application of the challenge application) the skin reaction were observed and recorded according to the Magnusson and Kligmann grading scale. Approximately 24 hours after this observation a second observation (72 hours) were made and skin reaction was again recorded.MAGNUSSON AND KLIGMAN GRADING SCALE 0 = no visible change 1 = discrete or patchy erythema 2 = moderate and confluent erythema 3 = intense erythema and swellingOBSERVATION - Skin reaction: 24, 48, 72 and 96 hours after intradermal injection, 48,72 and 96 hours after induction – topical application, 48 and 72 hours after challenge - Clinical signs of intoxication and health condition: daily - Mortality/viability: daily - Body Weight: 0 and 24th day
- Challenge controls:
- MAGNUSSON AND KLIGMAN GRADING SCALE 0 = no visible change 1 = discrete or patchy erythema 2 = moderate and confluent erythema 3 = intense erythema and swelling
- Positive control substance(s):
- yes
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % (w/w)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema without another clinical manifestation
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5 % (w/w)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema without another clinical manifestation
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- without clinical changes
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- without clinical changes
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance, Direct Black 112, caused a positives skin reaction in 6 of 20 animals, i.e. in 30 % of animals which were exposed to the test substance. The exposed animals showed no other negative clinical symptoms throughout the experiment.The body weight of animals increased though the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.The test substance, Direct Black 112, was shown to be a contact allergen in guinea pigs.
- Executive summary:
The test substance, Direct Black 112, was tested for the assessment of skin allergic effects using albino guinea pigs.
The test was performed according to the EU Method B.6 Skin sensitisation. The method is analogous to the OECD Test Guideline No. 406 Skin Sensitisation. The Magnusson and Kligman maximization procedure was followed. The pilot experiment was implemented on 3 animals. The main test was performed on 20 treated and 10 control animals.
The experiment proceeded in three phases: two induction phases (intradermal injections and topical application) and the challenge phase. Potential skin reactions were evaluated at the end of experiment.
The evaluation of skin reactions in the exposed group carried out at 48 hours after the start of the challenge phase showed discrete erythema in 1 animal. Evaluation at 72 hours after the start of the challenge phase of study showed discrete erythema in next 5 animals. No other negative clinical symptoms through the experiment were recorded.
The test substance, Direct Black 112, caused a positives skin reaction in 6 of 20 animals, i.e. in 30 % of animals which were exposed to the test substance. The exposed animals showed no other negative clinical symptoms throughout the experiment.
The body weight of animals increased though the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.
The test substance, Direct Black 112, was shown to be a contact allergen in guinea pigs.
Reference
Body weight of the animals throughout the experiment (average values):
Treated group (20 animals):
- Start of study: 384 g
- End of study: 563 g
- Increment: 179 g
Control group (10 animals):
- Start of study: 324 g
- End of study: 487 g
- Increment: 163 g
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with GPMT skin sensitisation test result and pursuant to the classification rules declared in Regulation (EC) No. 1272/2008, the test substance, Direct Black 112, is classified as Skin Sens. 1B.
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