Registration Dossier
Registration Dossier
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EC number: 201-906-0 | CAS number: 89-41-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: wellperformed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-nitro-p-anisic acid
- EC Number:
- 201-906-0
- EC Name:
- 3-nitro-p-anisic acid
- Cas Number:
- 89-41-8
- Molecular formula:
- C8H7NO5
- IUPAC Name:
- 4-methoxy-3-nitrobenzoic acid
- Details on test material:
- purity: 98.2 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: approximately 3 - 5 months
- Weight at study initiation: about 2.7 - 3.3 kg
- Housing: in completely air conditioned rooms in single cages
- Diet: Altromin 2123 (ad libitum), 15 g hay per day
- Water: deionized and dechlorinated water from automatic suspensors ( ad libitum):
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+- 3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye was taken as control
- Amount / concentration applied:
- 100 mg into the left conjunctivae sac
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with saline
- Time after start of exposure: 24 hours
SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae: 0 - 3; chemosis: 0 - 4
TOOL USED TO ASSESS SCORE:UV lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 2 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 0.9 hours
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0.9 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 0.9 hours
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is slightly irritating to the eyes but not subject for classification
- Executive summary:
The substance was tested for eye irritation according to OECD guideline 405. 3 male New zealind White rabbits were administered 100 mg of the substance into the left conjunctivae sac. After 24 hours the eyes were washed. After 1 to 24 hours after application the conjunctivae showed an intensive red colour. The iris was also red. All clinical signs had disappeared after 72 hours.
Therefore, the substance has to be classified as slightly irritant but is not subject for classification
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