Registration Dossier
Registration Dossier
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EC number: 260-126-9 | CAS number: 56358-17-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US Federal Register 38, No. 187, § 1500.42
- Deviations:
- yes
- Remarks:
- limited reporting, observation period: 72 hours
- GLP compliance:
- no
Test material
- Reference substance name:
- N-(2-ethylhexyl)naphthalen-2-amine
- EC Number:
- 260-126-9
- EC Name:
- N-(2-ethylhexyl)naphthalen-2-amine
- Cas Number:
- 56358-17-9
- Molecular formula:
- C18H25N
- IUPAC Name:
- N-(2-ethylhexyl)naphthalen-2-amine
- Details on test material:
- - Name of test material (as cited in study report): N-(2-Ethylhexyl)-2-napthalinamin
- Physical state: liquid
- Analytical purity: 80%
- Impurities (identity and concentrations): 20% Shellsol
- Lot/batch No.: 79/502
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean weight: 3.59 kg
- Housing: no data
- Diet: Ssniff, no further data
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM: accordings to draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.33
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: expected to reverse within 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24748/72 hours
- Score:
- 0
Any other information on results incl. tables
The mean scores (24/48/72 hours) for corneal opacity, iris lesions and chemosis were 0 and the mean score for redness of the conjunctivae was 1.33. The substance is not irritating to eyes according to EU and GHS-criteria.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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