Registration Dossier
Registration Dossier
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EC number: 606-936-1 | CAS number: 2210-24-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- the deviations did not impact the study results
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- yes
- Remarks:
- the deviations did not impact the study results
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August, 1998
- Deviations:
- yes
- Remarks:
- the deviations did not impact the study results
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent partial revisions
- Version / remarks:
- November 2000
- Deviations:
- yes
- Remarks:
- the deviations did not impact the study results
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 13304-62-6
- Cas Number:
- 13304-62-6
- IUPAC Name:
- 13304-62-6
- Reference substance name:
- N-benzylacrylamide
- IUPAC Name:
- N-benzylacrylamide
Constituent 1
Constituent 2
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: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: Controlled environment. Individually in labellad cages with perforated floors (Scanbur, Denmark, 55x44x37.5 cm)
- Diet (e.g. ad libitum): Pelleted diet for rabits (K-H from SSNIFF Spezialdiäten GmbH, Soest, Germany), 100 g/day. Hay (Tecnilab-BMI BV, Someren, The Netherlands) was provided at least 3 times a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22.9°C
- Humidity (%): 31-62%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12/03/2007 To: 17/04/2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 45.8mg (approximately 0.1ml)
- Observation period (in vivo):
- 1, 24, 48 and 72 hour, and 7 days
- Number of animals or in vitro replicates:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Reversibility:
- fully reversible within: 7days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- other: in each animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- other: in each animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Additionally, treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage.
- Irritation parameter:
- other: ocular corrosion
- Basis:
- other: in each animal
- Time point:
- other: during the entire test period
- Remarks on result:
- other: no evidence of ocular corrosion
- Other effects:
- No staining of (peri)ocular tissues by the test substance observed.
Remants of the test substance were present in the eye on day 1.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Based on a OECD 405 study, CH03543 should be classified under GHS as Category 2B (mildly irritating to the eyes).
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