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EC number: 260-125-3 | CAS number: 56358-10-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1997 - Mar 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- EC Number:
- 260-125-3
- EC Name:
- N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Cas Number:
- 56358-10-2
- Molecular formula:
- C32H37N5
- IUPAC Name:
- N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Test material form:
- solid
- Details on test material:
- Batch number ZD 00883/044. Manufactured Oct 1996
91.3% purity. Impurity is residual solvent Shellsol AB
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr K. Thomae GMBH, BIBERACH
- Age at study initiation: Young adult
- Weight at study initiation: 3.77kg - 3.96kg
Animal 1: 3.77kg (Male)
Animal 2: 3.96kg (Male)
Animal 3: 3.92kg (Male)
Animal 4: 3.78kg (Male)
- Housing: 1 animal per cage. Stainless steel wire mesh. Floor area 3000cm2. No bedding in the cages, sawdust in waste trays.
- Diet: Kliba-Labordiaet, Klingentalmuehle AG, Switzerland. About 130g per animal per day.
- Water: About 250mL tap water per animal per day
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other:
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1ml
The material was first heated to 90C then cooled to body temperature before application. - Duration of treatment / exposure:
- 24 hours (24 hours after application the substance was washed out with tap water)
- Observation period (in vivo):
- 1 hour
24 hour (the 24 hour reading was taken after the substance had been washed out.
48 hour
72 hour
8 days (Animals 2 and 3 only)
15 days (Animals 2 and 3 only)
21 days (Animals 2 and 3 only)
28 days (Animals 2 and 3 only) - Number of animals or in vitro replicates:
- 4 animals in total
1 animal in an intitial step.
As no further findings were noted, a further 2 confirmatory animals. Some symptoms were observed in one of these animals and it was unclear if they were due to the test substance.
Therefore, to clarify the results, a 4th animal was then tested. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
Initially 3 animals had the test substance applied. As the irritant potential of the substance was unknown, 1 animal was tested as a first step. As no severe findings were noted, another 2 rabbits were tested. To clarify the results, a further animal was tested.
Animal 1 initially application date 03-Nov-97
Animals 2 and 3 application date: 10-Nov-97
The effects were reversible in 2 animals, In one animal, opacity grade 1 over an area of less than a quarter was observed from 24 hours to 28 days. As no effects on the cornea were observed in the other 2 animals, and the grade or size of the observed corneal opacity did not change during the observation period, it was assumed that it was not related to the test substance. Therefore another animal was tested and the animal with corneal opacity was excluded from the evaluation of eye irritancy properites of the test substance.
Animal 4 application date: 12-Jan 1998.
The findings which were noted in animal 4 were reversible within 48 hours after application, thus the observation period for this animal was terminated after 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 1
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The mean scores were calculated based on the readings at 24 hour, 48 hours and 72 hours. The full individual readings are tabulated below. Animal 2 was excluded from the mean calculations as it was determined that the effects seen were not due to the test substance.
Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means.
Time point of reading |
Animal |
Cornea |
IRIS |
CONJUCTIVA |
SYMPTOMS (see key below) |
|||
OP |
AR |
RED |
SW |
DI |
||||
1 hour |
01 |
- |
- |
- |
- |
1 |
2 |
A |
02 |
- |
- |
- |
- |
1 |
2 |
A |
|
03 |
- |
- |
- |
- |
1 |
2 |
A |
|
04 |
- |
- |
- |
- |
1 |
1 |
A, B |
|
24 hours |
01 |
0 |
0 |
0 |
1 |
1 |
1 |
B |
02 |
1 |
1 |
0 |
2 |
1 |
1 |
B |
|
03 |
0 |
0 |
0 |
2 |
0 |
1 |
B |
|
04 |
0 |
0 |
0 |
0 |
1 |
1 |
B |
|
48 hours |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
02 |
1 |
1 |
0 |
2 |
1 |
0 |
B |
|
03 |
0 |
0 |
0 |
1 |
0 |
0 |
B |
|
04 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
|
72 hours |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
SD, B |
02 |
1 |
1 |
0 |
1 |
0 |
0 |
B |
|
03 |
0 |
0 |
0 |
1 |
0 |
0 |
B |
|
04 |
0 |
0 |
0 |
0 |
0 |
0 |
SD, B |
|
8 days |
02 |
1 |
1 |
0 |
0 |
0 |
0 |
B |
03 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
|
15 days |
02 |
1 |
1 |
0 |
0 |
0 |
0 |
B |
03 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
|
21 days |
02 |
1 |
1 |
0 |
0 |
0 |
0 |
B |
03 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
|
28 days |
02 |
1 |
1 |
0 |
0 |
0 |
0 |
B |
03 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
|
Mean (24h, 48h 72h results) |
01 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
|
02 |
1.0 |
|
0.0 |
1.7 |
0.7 |
|
Animal excluded from evaluation |
|
03 |
0.0 |
|
0.0 |
1.3 |
0.0 |
|
|
|
04 |
0.0 |
|
0.0 |
0.0 |
0.3 |
|
|
|
Overall Mean |
|
0.3 |
|
0.0 |
0.8 |
0.3 |
|
|
Overall mean excluding animal 2 |
|
0.0 |
|
0.0 |
0.5 |
0.2 |
|
|
Symptoms Key
A: Index for corneal opacity, area, iris and conjunctivae redness could not be read because of staining due to the colour of the test substance.
B: Fur of the head reddish discoloured.
SD: Study discontinued because the animal was free of symptoms.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not irritating
- Conclusions:
- The test substance is not classified as irritating to eyes according to EU CLP criteria.
- Executive summary:
The test material was assessed for eye irritation/corrosion according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, and OECD Test guideline 405.
The potential of the test substance to cause damage to the conjuntiva, iris or cornea was assessed in 4 white New Zealand rabbits, subjected to a singular ocular application of 0.1ml of the test susbstance. The eyes were examined at 1 hour, 24 hours, 46 hours and 72 hours. For 2 of the animals examinations were also carried out at 8, 15, 21 and 28 days. One animal was subsequently excluded from the study due to eye effects not attributable to the test substance. The avergage score (24 to 74 hours) for irritation was calculated to be 0.0 for corneal opacity, 0.0 for Iris, 0.5 for Conjunctival redness and 0.2 for Chemosis.
The individual animal mean scores for the 24, 48 and 72 hr time-point indicated that this material would not be classified under EU regulations.
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