Registration Dossier
Registration Dossier
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EC number: 203-765-0 | CAS number: 110-41-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-08-16 to 1999-08-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-methylundecanal
- EC Number:
- 203-765-0
- EC Name:
- 2-methylundecanal
- Cas Number:
- 110-41-8
- Molecular formula:
- C12H24O
- IUPAC Name:
- 2-methylundecanal
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Aldehyde C12 MNA; Undecanal, 2-methyl
- Substance type: Colourless liquid
- Physical state: Liquid
- Analytical purity: No data, but described as "undiluted".
- Batch No: 8090059
- Stability under test conditions: > 1 yr
- Storage condition of test material: Cool and dry
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino rabbit of stock Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623, Lille Skensved, Denmark
- Age at study initiation: No data
- Weight at study initiation: 2.2 - 2.9 kg
- Housing: Individually housed in PPO cages (floor area 2576 cm²)
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: ≥ 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 10 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml per treatment. - Duration of treatment / exposure:
- 24 hr
- Observation period (in vivo):
- 14 days (observations at 1 hr, 24 hr, 48 hr, 72 hr, 7 days, 14 days).
- Number of animals or in vitro replicates:
- 4 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Sodium chloride solution
- Time after start of exposure: 24 hr
SCORING SYSTEM:
For details on scoring system, please refer to the supporting materials attached.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- For full results please refer to the attached supporting information.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was assessed for eye irritation according to OECD guideline 405. The study was performed with more than 3 animals. In this case specific provisions apply to the classification criteria in CLP Regulation (EC) no. 1272/2008. In accordance with this classification criteria the test substance is not irritating to eyes.
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