Registration Dossier
Registration Dossier
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EC number: 228-782-0 | CAS number: 6358-64-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-03-04 to 1986-03-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP-study according to previous OECD-TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement included in full study report.
Test material
- Reference substance name:
- 4-chloro-2,5-dimethoxyaniline
- EC Number:
- 228-782-0
- EC Name:
- 4-chloro-2,5-dimethoxyaniline
- Cas Number:
- 6358-64-1
- Molecular formula:
- C8H10ClNO2
- IUPAC Name:
- 4-chloro-2,5-dimethoxyaniline
- Details on test material:
- - Product code: GUDC 10
- Molecular mass: 187.5 g/mol
- Appearance: light brown, solid
- Melting point: 117.5 °C
- Density: 1.3 kg/l
- pH in water: neutral
- Solubility: slightly soluble in water, soluble in ethanol, toluene, acetone, xylol, benzene, ether
- Purity: 98 %
- Impurities: approx. 0.5 % 1-amino-2,5-dimethoxybenzene
- Production date: 1984
- Storage: in the dark at 22 °C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Hoechst AG, Kastengrund, conventional breed
- Identification: Numbered earmarks
- Weight: 2.2 - 3.2 kg
- Age: approx. 3 - 5 months
- Housing: in air conditioned rooms, single cages
- Room temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Diet: Altromin 2123 - rabbit, ad libitum, as well as approx. 15 g of hay daily
- Water: deionised, chlorinated water from automatic feeder, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Yes. Untreated eye served as control.
- Amount / concentration applied:
- - Amount of test substance applied: 100 mg
- Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 1, 24, 48 and 72 hrs after application of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Investigations of damage to the cornea using fluorescine solution (0.01 %) and ultraviolet light.
- Washing: * 24 hrs after application of the test substance.
* At each observation time, if treated eyes showed discharge or where examined for damage to the cornea
- Washing done with physiol. saline solution (37 °C)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the present study, 4-chloro-2,5-dimethoxyaniline is not classified and labelleded a eye irritant according to 83/467/EEC.
- Executive summary:
Based on the results of the present study, 4-chloro-2,5-dimethoxyaniline is not classified and labelleded a eye irritant according to 83/467/EEC.
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