Registration Dossier
Registration Dossier
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EC number: 603-101-3 | CAS number: 125962-78-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 17, 2003 - August 05, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Official Journal of the European Communities L383 A, Vol. 15, 29. December 1992.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 603-101-3
- EC Number:
- 603-101-3
- Cas Number:
- 125962-78-9
- Molecular formula:
- C21 H28 O2
- IUPAC Name:
- 603-101-3
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: About 35 weeks
- Weight at study initiation: 4.04 - 4.26 KG
- Housing: Separately in special rabbit cages (manufacturer: Becker, type K99/30 KU)
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: More than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24°C
- Humidity (%): 37 - 66%
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12hrs light
IN-LIFE DATES: From day 1 to day 8
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g per animal
- Duration of treatment / exposure:
- 8 days
- Observation period (in vivo):
- 24, 48, and 72 hours, then daily up to day 8 of the experimental part
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
SCORING SYSTEM: According OECD-Guideline
TOOL USED TO ASSESS SCORE: Hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.333
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed at the cornea or iris.The conjunctivae showed redness (score 1) at the first reading (1 hour) in all animals and in one animal at the second reading (24 hours). Thereafter no signs of irritation were observed. No abnormalities were detected in the untreated eyes.
- Other effects:
- - Clinical signs: No signs of clinical toxicity were detected.
- Mortality: All animals survived the observation period.
- Body weights: Body weight development of the treated rabbits was inconspicious.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vivo eye irritation study according to OECD guideline 405, the test item showed no relevant eye irritating potential.
- Executive summary:
The study was performed according to OECD guideline 405 under GLP conditions. The test item was tested for its eye irritating properties. Prior to testing, the hen's egg test on the chorioallantoic membrane was performed and no irritating potential could be detected. The test for primary eye irritation was performed initially with one animal and followed by the confirmatory test with two further animals. For the test of primary eye irritation, the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for a further 7 days. No signs of irritation were observed at the cornea or iris. The conjunctivae showed redness (score 1) at the first reading (1 hour) in all animals and in one animal at the second reading (24 hours). Thereafter no signs of irritation were observed. No abnormalities were detected in the untreated eyes. No relevant eye irritating potential could be detected. The test item should not be classified as an eye irritant.
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