Registration Dossier
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EC number: 445-040-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Ltd., Toxicology, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FAT 40'812/A
- Purity: Approx. 75%
- Lot/batch No.: WP 3/03
- Expiration date: 23 April 2010
- Stability: Stable under storage conditions
- Storage conditions: At room temperature (range of 20 ± 3 °C), away from direct sunlight
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at treatment: 10 weeks (male), 11 weeks (females)
- Bodyweight at treatment: 2227 - 2574 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd., Füllinsdorf) and haysticks 4646 (batch no. 0301, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 28/03) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- up to 21 days
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- TREATMENT:
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.1 g of FAT 40'812/A was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
OBSERVATIONS:
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/96/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17, and 21 days after instillation. When present, corrosion and/or staining of conjunctivae, sclerae and cornea by the test item were recorded and reported.
TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7, 10, 14, 17, 21 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7, 10, 14, 17, 21 days
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24 hours
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.67
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7, 10, 14, 17, 21 days
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48, 72 hours and 7, 10, 14, 17, 21 daysdays
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjunctivae was observed in all animalsat the 1- and 24 hour reading. Slight redding was still noted in two animals at the 48-hour examination and persisted in one animal up to 72-hours after treatment. Moderate swelling of the conjunctivae (oedema) was noted in all animals at the 1-hour reading. Slight swelling of the conjunctivae was still evident in two animals 24 hours after treatment. Slight reddening of the sclerea was present in all animals at the 1-hour reading and persisted in one animal up to 24-hours after treatment. Slight to moderate discharge was noted in all animals at the 1-hour examination. One animal screamed immediately after application of the test item for a few seconds.
- No corrosion of the cornea was observed at any of the reading times. - Other effects:
- - Slight red staining of the treated eyes produced by the test item was observed in all animals one hour after treatment and persisted in all animals up to the end of the observation period. Red remnants of the test item were observed in the eye or conjunctival sac of all animals one hour after treatment.
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. One animal screamed after the application.
- The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- These effects were reversible and were no longer evident 7 days after treatment. Red staining of the treated eyes produced by the test item was observed in all animals at the 1 -hour examination and persisted up to the observation 21 days after treatment. No abnormal findings were observed in the iris of any animal at any of the examinations, no corrosion was observed at any of the measuring intervals and no clinical signs were observed.
- Executive summary:
In a GLP compliant eye irritation study, performed according to OECD guideline 405, test substance (0.1 g) was placed in the conjunctional sac of the left eye of 3 New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17, and 21 days after test item instillation. The instillation of the test substance into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerea, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment. Red staining of the treated eyes produced by the test item was observed in all animals at the 1 -hour examination and persisted up to the observation 21 days after treatment. No abnormal findings were observed in the iris of any animal at any of the examinations, no corrosion was observed at any of the measuring intervals and no clinical signs were observed.
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