Registration Dossier
Registration Dossier
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EC number: 443-950-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 April 2002 to 18 April 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): NALCO 01WC026 / PSO
- Lot/batch No.:XC1M0642
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: 7 - 9 weeks old
- Weight at study initiation: 1.424 to 1.618 kg
- Housing: Animals were housed individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5cm)
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx 100g /day. In addition hay was provided twice a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each animal remained untreated and served as the reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml of test substance - Duration of treatment / exposure:
- A single application of the test substance. Each animal was treated by instillation of 0.1 ml of the test susbstance, in the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together t for about one second to prevent loss of the test substance.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: See table 1 of attachment S7.3.2 Eye Irritation Results Tables 1 - 3.pdf
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: 2% fluorescein in water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 & 72 h ours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of the test substance into one eye of each three animals resulted in irriation of the conjunctiva, which was seen as redness, chemosis and discharge. The irriation had completely resolved within 24 hours in all animals.
No iridial irritation or cornela opacity was observed, and treatment of the eyes with 25% fluorescein 24 hours after treatment revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
For individual; and mean eye irriattion scores see See table 2 & 3 of the attachment S7.3.2 Eye Irritation Results Tables 1 - 3.pdf - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred
Any other information on results incl. tables
No staining of (peri) ocular tissues by the test substance was observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classified as an eye irritant.
- Executive summary:
The study was carried out based on the guidelines 92/69 EEC, B.5, "Acute Toxicity - Eye Irritation" and OECD Guideline no. 405
"Acute Toxicity - Eye Irritation/Corrosion"
Single samples of 0.1 ml of the test substance were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.
Instillation of the test substance resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 24 hours in all animals.
Based on these results and according to the EC criteria for classification and labelling the test substance is not classified as an eye irritant.
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