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EC number: 205-206-6 | CAS number: 135-62-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.-22.07.1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register Vol 38, no 187, S. 27019, 1973
- GLP compliance:
- no
- Remarks:
- pre-guideline study
Test material
- Reference substance name:
- 3-hydroxy-2'-methoxy-2-naphthanilide
- EC Number:
- 205-206-6
- EC Name:
- 3-hydroxy-2'-methoxy-2-naphthanilide
- Cas Number:
- 135-62-6
- Molecular formula:
- C18H14NNaO3
- IUPAC Name:
- 3-hydroxy-2'-methoxy-2-naphthanilide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Housing: single caged
- Diet: standard diet ERKA 8300, ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye served as control respectively
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively
- Washing: Washing with physiological saline 24 h after administration
- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium, under UV light
The eyes are examined and the grade of ocular reaction is recorded at 1, 24, 48, and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 0.39
- Max. score:
- 4
- Reversibility:
- other: Grade 1 opacity observed was fully reversible in 5 animals after 72 h.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured at any time
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 0.94
- Max. score:
- 4
- Reversibility:
- other: Chemosis was fully reversible in 5 animals after 72 h .
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 1.17
- Max. score:
- 3
- Reversibility:
- other: Redness was fully reversible in 2 animals after 72 h.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 7 h
- Score:
- 22
- Max. score:
- 110
- Reversibility:
- other: A maximal eye irritation index of 5 was observed after 72 h
- Remarks on result:
- other: slightly irritant
- Other effects:
- Discharge was observed after 1 h until 72 h.
Any other information on results incl. tables
Table 1: Individual scores
Animal no |
Evaluation Interval |
Cornea |
Conjunctiva |
Iris |
Eye Irritation Index (mean) |
||
|
|
Opacity |
Redness |
Chemosis |
Discharge |
|
|
51 |
1 h |
1 |
1 |
2 |
1 |
0 |
13 |
52 |
0 |
1 |
2 |
1 |
0 |
||
53 |
1 |
1 |
2 |
1 |
0 |
||
54 |
0 |
1 |
2 |
1 |
0 |
||
56 |
1 |
1 |
1 |
1 |
0 |
||
58 |
0 |
1 |
2 |
1 |
0 |
||
51 |
7 h |
1 |
2 |
2 |
2 |
0 |
22 |
52 |
1 |
2 |
3 |
2 |
0 |
||
53 |
1 |
1 |
3 |
2 |
0 |
||
54 |
0 |
1 |
2 |
2 |
0 |
||
56 |
1 |
2 |
3 |
2 |
0 |
||
58 |
1 |
2 |
2 |
2 |
0 |
||
51 |
24 h |
1 |
2 |
2 |
2 |
0 |
18 |
52 |
1 |
2 |
2 |
2 |
0 |
||
53 |
1 |
2 |
2 |
2 |
0 |
||
54 |
0 |
1 |
1 |
0 |
0 |
||
56 |
1 |
2 |
1 |
2 |
0 |
||
58 |
1 |
1 |
2 |
1 |
0 |
||
51 |
48 h |
1 |
2 |
2 |
1 |
0 |
7 |
52 |
0 |
1 |
0 |
1 |
0 |
||
53 |
0 |
1 |
1 |
1 |
0 |
||
54 |
0 |
0 |
0 |
0 |
0 |
||
56 |
0 |
1 |
1 |
1 |
0 |
||
58 |
0 |
1 |
1 |
1 |
0 |
||
51 |
72 h |
1 |
2 |
2 |
2 |
0 |
5 |
52 |
0 |
0 |
0 |
0 |
0 |
||
53 |
0 |
1 |
0 |
0 |
0 |
||
54 |
0 |
0 |
0 |
0 |
0 |
||
56 |
0 |
1 |
0 |
0 |
0 |
||
58 |
0 |
1 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- According to the classification criteria of the FDA guideline the test item is slightly irritatnt to eyes.
According to Regulation (EC) no 1272/2008 the test substance has to be regarded as non irritating to eyes. This conclusion is legitimate although the testing regime differs slightly from today's standard methods (scoring system is identical to the currently used system) - Executive summary:
Test material was subject to an acute eye irritation/corrosion test in 6 Himalayan White rabbits according to FDA guideline. 100 mg test substance were placed into the conjunctival sac of one eye each of 6 rabbits. The effects were observed for 72 h. The test item caused grade 1 corneal opacity after 1 h, grade 3 chemosis after 7 h and grade 2 conjunctival reddening grade after 7 h until 48 h. All effects for all irritation parameter during the study were not fully reversible in all animals after 72 h. The determined mean values after 24, 48 and 72 h of the irritation parameter were < 1 (for corneal opacity and iris) and < 2 for conjunctival redness and chemosis.
Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 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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