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EC number: 276-982-1 | CAS number: 72905-97-6
- 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
Skin irritation: not irritating.
Eye irritation: not irritating.
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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Duration of treatment / exposure:
- The right and left flank of animals was shaved at area about 6 x 6 cm.
The test sample 0.5 g, moistened with water, was applied on intact skin to 3 experimental animals. The test sample was covered by gauze, foil and cellulose wool. Cotton was held in place with technical tape so that the test sample was in contact with skin. Scarification was performed with using scarify needle (without bleeding). The test sample was applied on scarified skin by the same way as on intact skin. At the end of 4 hours exposition, dressing with the test sample was removed. - Observation period:
- Rabbits were examined for signs of erythema and oedema at 1, 24, 48 and 72 hr after patch removal.
- Number of animals:
- 3 females and males
- Irritation parameter:
- erythema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0.75
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0.75
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0.75
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48, 72 hr
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
- Executive summary:
Direct black 112 was tested for the dermal irritation. 3 male and female New Zealand Albino breed rabbits were used for the study. The test substance was exposed to skin for 4 hours. The examination for sign of erythema and oedema is at 1, 24, 48 and 72 hour after patch removal.
For the intact skin, very slight erythema was observed in 2 rabbits 1 hr after patch removal. No changes were observed in all animals in next time intervals.
For the sacrified skin, Slight erythema and slight oedema were observed in 2 animals 1 hour after patch removal. Very slight erythema and oedema were observed in one animal 24hrs. Very slight erythema without oedema in next one. No changes were observed in all animals in next time intervals.
The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
Reference
Clinical examination of intact skin
Very slight erythema without oedema was observed in one animal 1 hour after patch removal. Very slight erythma was observed in the 2ndanimal and in the 3rdanimal no changes were observed.
No changes were observed in all animals in next time intervals.
Examination of scarified skin
Slight erythema and slight oedema were observed in one animal 1 hour after patch removal. Slight erythema and very oedema were observed in next one animal and in the 3rdanimal no changes were observed.
Very slight erythema and very slight oedema were observed in one animal 24 hrs after patch removal. Very slight erythema without oedema in next one animal and no changes in the 3rdanimal were recorded in 24 hrs.
No changes were observed in all animals in next time intervals.
RESULT
The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- yes
- Duration of treatment / exposure:
- 3 male and female rabbits (New Zealand Albino breed) were more than 2.5 kg. No signs of diseases were observed at clinical check-in.
The test sample (0.1 g) was placed into the conjunctival sac of left eye of animal after gently pulling the lower lid away from the ball. After application the lids were gently held together for a few seconds. The right untreated eye served as a control. Three animals were used in test. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after application. In 1 hour after test sample application, the eye reaction was examined without rinse of water. In 24 hours, reaction of eye gently rinsed with water was performed. Examination of damage of cornea was performed using 2% solution of fluorescein. Examination of eye reaction in 48 hours was performed without fluorescein. Examination in 72 hours was performed using 2% fluorescein.
- Number of animals or in vitro replicates:
- 3 male and female rabbits (New Zealand Albino breed)
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal: 38
- Time point:
- other: overall at 24, 48 and 72 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean of all observation
- Irritation parameter:
- cornea opacity score
- Remarks:
- corena area
- Basis:
- animal: 38
- Time point:
- other: overall 24, 48 and 72 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Mean of all observation
- Irritation parameter:
- iris score
- Basis:
- animal: 38
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- congestion
- Basis:
- animal: 38
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 38
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal: 38
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal: 39
- Time point:
- other: overall 24, 48 and 72 hr
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- animal: 39
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- iris score
- Basis:
- animal: 39
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- congestion
- Basis:
- animal: 39
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 39
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal: 39
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal: 40
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- animal: 40
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- iris score
- Basis:
- animal: 40
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- congestion
- Basis:
- animal: 40
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 40
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal: 40
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- other: mean of all observation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.
- Executive summary:
The sample, Direct black 112, was tested for the eye irritation. 3 New Zealand Albino males and females rabbits were applied with 0.1 g Direct black 112 on the conjunctival sac of left eye of animals. Most of the effects were observed at conjunctiva within 48 hrs. Almost no effect was observed 72 hours after treatment, only slight congestion of conjunctiva and very slight discharge in one animal.
The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.
Reference
The following clinical signs were observed 1 hour after application: in one animal – congested conjunctiva (middle), strong serosal discharge colored by the test sample, in two animals: oedema of lids, strong serosal discharge; congestion of conjunctiva was not evaluated by the reason of coloring by the test sample.
The following clinical signs were observed 24 hours after application: in one animal – smoke opacity of cornea, congested conjunctiva (middle) and serosal discharge, oedema of lids (middle), serosal discharge (middle), in one animal slightly congested conjunctiva were recorded.
Examination in 48 hours after application showed very slight congestion of conjunctiva and in one animal slight congestion of conjunctiva.
Examination in 72 hours after application showed very slight congestion of conjunctiva and very slight discharge in one animal; in two animals no finding were recorded.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Direct black 112 was tested for the dermal irritation. 3 male and female New Zealand Albino breed rabbits were used for the study. The test substance was exposed to skin for 4 hours. The examination for sign of erythema and oedema is at 1, 24, 48 and 72 hour after patch removal. For the intact skin, very slight erythema was observed in 2 rabbits 1 hr after patch removal. No changes were observed in all animals in next time intervals.
The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
The sample, Direct black 112, was tested for the eye irritation. 3 New Zealand Albino males and females rabbits were applied with 0.1 g Direct black 112 on the conjunctival sac of left eye of animals. Most of the effects were observed at conjunctiva within 48 hrs. Almost no effect was observed 72 hours after treatment, only slight congestion of conjunctiva and very slight discharge in one animal.
The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.
Justification for classification or non-classification
Based on the available data, the substance is not classified for skin irriation and eye irritation
according to CLP regulation 1272/2008.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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