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Registration Dossier
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EC number: 202-816-4 | CAS number: 100-07-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is from safety assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SIDS dossier of p-Methoxybenzaldehyde
- Author:
- OECD SIDS
- Year:
- 2 009
- Bibliographic source:
- OECD HPV Chemical Programme, SIDS Dossier approved at SIAM 29 (20 - 23 October 2009)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38, No. 187, § 1500.42
- Principles of method if other than guideline:
- An eye irritation study of p-Methoxybenzaldehyde (CAS No: 123-11-5) was conducted on Vienna White rabbits to determine the degree of eye irritancy caused by the chemical.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-methoxybenzaldehyde
- Cas Number:
- 123-11-5
- Molecular formula:
- C8H8O2
- IUPAC Name:
- 4-methoxybenzaldehyde
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): p-methoxybenzaldehyde
- Molecular formula : C8H8O2
- Molecular weight : 136.149 g/mol
- Substance type: Organic
- Physical state: liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Anisic aldehyde/ p-Anisaldehyde
- Molecular formula: C8H8O2
- Molecular weight: 136.1492 g/mol
- Substance type: organic
- Physical state: liquid
-Smiles: COc1ccc(C=O)cc1
-InChI: 1S/C8H8O2/c1-10-8-4-2-7(6-9)3-5-8/h2-6H,1H3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- - Source: Gaukler
- Weight at study initiation: male: 3.16 kg; mean of 2 females: 2.46 kg
- Diet (e.g. ad libitum): Ssniff, Intermast
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100% (0.1mL)
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was not washed out
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein (only at the final reading)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. All the observed effects were reversible within 72 hours.
Any other information on results incl. tables
OBSERVATION TABLE |
|||||
Ocular reactions |
Animal no |
1 hour |
24 hours |
48 hours |
72 hours |
Opacity |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
Mean:0.00 |
|||||
Cornea area |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
Mean:0.00 |
|||||
Iritis |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
Mean:0.00 |
|||||
Redness |
1 |
2 |
1 |
0 |
0 |
2 |
2 |
1 |
1 |
0 |
|
3 |
1 |
1 |
0 |
0 |
|
Mean:0.44 |
|||||
Chemosis |
1 |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
|
3 |
2 |
0 |
0 |
0 |
|
Mean:0.00 |
|||||
Discharge |
1 |
2 |
1 |
0 |
0 |
2 |
2 |
1 |
0 |
0 |
|
3 |
2 |
1 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test material p-Methoxybenzaldehyde (CAS No: 123-11-5) was considered to be not irritating to the eyes of Vienna White rabbits.
- Executive summary:
Skin irritation study of p-Methoxybenzaldehyde (CAS No: 123-11-5) was conducted on three Vienna White rabbits to determine the degree of eye irritancy.
The undiluted chemical was instilled into the eye of each rabbit and eyes were not rinsed. The eyes were scored according toDraize method.
Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. All the observed effects were reversible within 72 hours.
According to the conditions of the test, the test substance does not fullfil the criteria of 67/548/EEC and GHS UN for classification, respectively. Therefore, the chemical p-Methoxybenzaldehyde (CAS No: 123-11-5) wasconsidered to be not irritating to theeyes of Vienna White rabbits.
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