Registration Dossier
Registration Dossier
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EC number: 609-057-1 | CAS number: 35052-92-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted in compliance with GLP and according to the OECD guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 32132-92-6
- EC Number:
- 608-707-1
- Cas Number:
- 32132-92-6
- IUPAC Name:
- 32132-92-6
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 4-6 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Single exposure, no washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 4 and 5 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 100 mg of the test item was administered per eye and tested in three animals. The test item was placed in the conjunctival sac of the right eye of
each animal after gently pulling the lower Iid away from the eyeball. The Iids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, 72 hours and 4 to 5 days after the
administration. The eye reactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein
and examined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Corneal opacitywas observed in all animals:
animal no. 1: 1 hour to 72 hours (grade 1) after instillation;
animal no. 2: 1 hour to 72 hours (grade 2) and 4 days (grade 1) after instillation;
animal no. 3: 24 to 72 hours (grade 2), 1 hour and 4 days (grade 1) after
instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 1 ( 1/4 of the surface) and in animal nos. 2 and 3 ( 1/2 of the surface).
Irritation of the iris (grade 1) was observed in animal nos. two and three 24 to 72 hours after instillation.
Conjunctival redness (grade 1) was observed in all animals 1 hour to 72 hours after instillation.
Conjunctival chemosis (grade 1 or 2) was observed in all animals 1 hour to 72 hours, in animal no. 2 until 4 days after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- All findings such as corneal opacity (max. grade 2), iris scor (max. grade 1), conjunctivae redness (max. grade 1) and conjunctivae chemosis (max. grade 2) observed with a different grading in some or all animals during the first 72 hours after dosing, were fully reversible within 5 days after treatment.
- Executive summary:
All findings such as corneal opacity (max. grade 2), iris scor (max. grade 1), conjunctivae redness (max. grade 1) and conjunctivae chemosis (max. grade 2) observed with a different grading in some or all animals during the first 72 hours after dosing, were fully reversible within 5 days after treatment. Therefore the ALA-DANE salt is considered to be irritating to the eyes.
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