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Reaction Mass of disodium [(E)-7-nitro-3-oxido-4-((2-oxidonaphthalen-1-yl)diazenyl)naphthalene-1-sulfonate) (E)-1-((3,5-dinitro-2-oxidophenyl)diazenyl)naphthalen-2-olate) chromate(2-)] and Hydrogen [(E)-7-nitro-3-oxido-4-((2-oxidonaphthalen-1-yl)diazenyl)naphthalene-1-sulfonate)(E)-1-((3,5-dinitro-2-oxidophenyl)diazenyl)naphthalen-2-olate) chromate(2-)]
EC number: 943-640-4 | CAS number: -
- 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, rabbits (m/f), intact skin, not irritating
eye irritation, rabbits (m/f), washed and unwashed eye, not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 +/- 2° C, at a relative humidity of 55 +/- 10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved, one side intact and one side abraded
- Vehicle:
- other: propylene glycol + saline (70 : 30 parts)
- Amount / concentration applied:
- 0.5g of test item, 50% in the vehicle
- Duration of treatment / exposure:
- 24h
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and duringan observation period of 7 days.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- results on the abraded skin are also available, and the maximum mean value is 1, fully reversible within 72h. They were not inserted since the Regulation 1272/2008 does not take into account results on scarified skin for the skin irritation evaluation
- Interpretation of results:
- other: not classified under Rehulation 1272/2008
- Conclusions:
- The test item was tested for skin irritation potential. Under the experimental conditions the test item did not show skin irritation properties.
- Executive summary:
The test item was tested for skin irritation potential. A group of three males and females NZW rabbits were tested on shaved intact and abraded skin by a 24h exposure to the test item and readings were performed at 24h, 48 and 72h, 4 and 7 days for edema and erythema. Mean values over 24, 48 and 72h were used for assessing he skin irritation potential. Under the experimental conditions the tes item is not considered a skin irritant.
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:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 + 2° C, at a relative humidity of 55+10 % and on a 10 hour light cycle day.The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- few seconds
- Observation period (in vivo):
- 24h, 48h, 72h, 4 and 7 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis, redness and discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis, redness and discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis, redness and discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis, redness and discharge
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis, redness and discharge
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis, redness and discharge
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- The test item was teted for eye irritation potential. Under the experimental conditions the item did not show any eye irritative properties.
- Executive summary:
The test item was teted for eye irritation potential. The left eye of three males and three females of NZW rabbits were exposed for a few seconds to the test item, and three of them were rinsed with physiological saline solution. The right eye was left untreated and served as control. The cornea, iris and conjuncitvae scores were determined at 24, 48, 72h, 4 and 7 days and resulted equal to zero. Under the experimental conditions the tested item is not considered as irritant to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
One study was performed to assess the skin irritation potential of the analogue test item (Huntsman 1980). Males and females of NZW rabbits were exposed to the test item and the mean values for edema and erythema over 24,48 and 72h observation period were recorded. Under the experimental conditions the test item is not considered as a skin irritant.
One study was performed to assess the eye irritation potentail of the analogue test item (Huntsman, 1980).
Males and females of NZW rabbits were exposed to the test item and the mean values for cornea, iris and conjunctivae over 24,48 and 72h observation period were recorded. Under the experimental conditions the test item is not considered as an eye irritant.
Based on the read across considerations the same results apply to Acid Black 107:1
Justification for classification or non-classification
Under Regulation 1272/2008 a substance is classified as skin irritant Cat. 2 if:
1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Mean values at 24, 48 and 72h for oedema or erythema are <2 for all animals and are completely reversible within 72h, therefore the test substance is not classified as skin irritant.
Under Regulation 1272/2008 a substance is classified as eye irritant Cat. 2 if it is present at least in 2 of 3 tested animals, a positive response of: 1) corneal opacity ≥ 1 and/or 2) iritis ≥ 1, and/or 3) conjunctival redness ≥ 2 and/or 4) conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
All the scores calculated as mean value at 24, 48 and 72h for the test substances for all tested animals are equal to zero, therefore the substance is not classified as eye irritant.
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