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EC number: 424-190-3 | CAS number: 105641-66-5 DIAZO ER 1273
- 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
The test substance was tested fo its potential to cause skin and eye irritation in studies according to OECD Guideline 404 and 405. As a result, the substance is not considered to be classified for skin or eye irritation.
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:
- 23rd June 1992 to 3rd July 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.2 kg
- Housing: singly
- Diet: ad libitum Altromin 2123 maintenance diet - rabbits
- Water: deionized, chlorinated water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: polyethylene glycol (0.5 mL)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- 0.5 g
VEHICLE
- 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations took place after 30-60 min, 24, 48 and 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm in the dorsal region of the body
- % coverage:
- Type of wrap if used: surgical plaster and semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: directly after removal of the patch - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 72 h after removal of the test patches all irritations were reversible.
- Other effects:
- From 30 min up to 48 h after removal of the patches the skin surface of the animals was large yellowish discoloured by the test compound.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the study according to OECD Guideline 404 the test item is not irritating to skin.
- Executive summary:
The test substance was tested for its potential to cause skin irritation in a study according to OECD Guideline 404. Three female New Zealand White rabbits were treated with a single dermal application under semiocclusive dressing for 4 hours. After removal of the patches, the test sites were scored according to Draize. No edema formation was noted, and only slight and reversibble erythema formation in two animals was recorded (24/48/72 hours mean values 0.3 and 0.7, respectively). Therefore, the test substance was shown to not cause skin irritation.
Reference
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:
- July 7-21, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3 kg
- Housing: singly
- Diet: ad libitum Altromin 2123 maintenance diet – rabbits and hay
- Water: deionized, chlorinated water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- 100 mg
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- The eyes were examined 1, 24, 48 and 72 houry after application of the test substance and after 7 days.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- From one hour up to 24 h the conjunctivae of the animals showed slight to obvious swellings with partial eversion of lids. Up to 72 h p.a. evident hyperaemie to diffuse deeper crimson coloured reddenings were noted. After 7 days the irritations were reversible.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the study according to OECD Guideline 405 the test item is not irritating to the eyes.
- Executive summary:
The test substance was tested for its potential to cause eye irritation in a study according to OECD Guideline 405. Three New Zealand White rabbits were treated with a single application of 100 mg test item in one eye. Signs of irritation were scored according to Draize. The 24/48/72 hours mean scores for animal No. 1/2/3 are the following: cornea scores: 0/0/0; iris scores: 0/0/0; conjunctiva scores: 1.3/1/2; chemosis scores: 0.3/0.3/0.3. All findings were reversible within 7 days. Therefore, the test substance is not considered to be classified for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The test substance was tested for its potential to cause skin irritation in a study according to OECD Guideline 404. Three female New Zealand White rabbits were treated with a single dermal application under semiocclusive dressing for 4 hours. After removal of the patches, the test sites were scored according to Draize. No edema formation was noted, and only slight and reversibble erythema formation in two animals was recorded (24/48/72 hours mean values 0.3 and 0.7, respectively). Therefore, the test substance was shown to not cause skin irritation.
Eye irritation:
The test substance was tested for its potential to cause eye irritation in a study according to OECD Guideline 405. Three New Zealand White rabbits were treated with a single application of 100 mg test item in one eye. Signs of irritation were scored according to Draize. The 24/48/72 hours mean scores for animal No. 1/2/3 are the following: cornea scores: 0/0/0; iris scores: 0/0/0; conjunctiva scores: 1.3/1/2; chemosis scores: 0.3/0.3/0.3. All findings were reversible within 7 days. Therefore, the test substance is not considered to be classified for eye irritation.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation/corrosion, the test item is not considered to be classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.
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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