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Registration Dossier
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EC number: 204-466-8 | CAS number: 121-34-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10/03/02 - 10/20/02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No certificate of analysis.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Simplified study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Vanillic acid
- EC Number:
- 204-466-8
- EC Name:
- Vanillic acid
- Cas Number:
- 121-34-6
- Molecular formula:
- C8H8O4
- IUPAC Name:
- 4-hydroxy-3-methoxybenzoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Vanillic acid
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature
- Stability under test conditions: yes
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: New Zealand White rabbits (Oryctolagus cuniculus)
- Sex: males and females
- Sources: Millbrook Breeding Labs, Amherst, MA.
- Weight at study initiation: 2.04 to 2.19 kg / at least 10 weeks old (adult). Weighed to nearest 10 g.
- Housing: individual housing, in suspended stainless steel.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 10 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 30 to 70%
- Air changes: 10 TO 15
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- other: no
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3 (2 males and 1 female).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no washing
SCORING SYSTEM: based on changes in cornea, iris, conjunctivae and chemosis, according to guideline OECD 405
TOOL USED TO ASSESS SCORE: Heine's ophthalmoscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours.
- Remarks on result:
- other: see table of results
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable.
- Remarks on result:
- other: see table of results
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable.
- Remarks on result:
- other: see table of results
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable.
- Remarks on result:
- other: see table of results
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see table of results
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours.
- Remarks on result:
- other: see table of results.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1/1/1 |
0/0/0 |
1/2/2 |
2/2/2 |
24 h |
1/1/1 |
0/0/0 |
1/1/2 |
1/1/1 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.33/0.33/0.33 |
0/0/0 |
0.33/0.33/0.66 |
0.33/0.33/0.33 |
Reversibility*) |
n. |
n. |
n. |
n. |
Average time (unit) for reversion |
c |
- |
c |
c |
*) Reversibility: c. = completely reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, Vanillic acid is not considered as irritating to eyes. Therefore, no classification is required according to EU criteria.
- Executive summary:
In an eye irritation study (Comparable to OECD 405, Reliablity 2, GLP), 0.1 mL of Vanillic acid was instilled into the conjunctival sac of the right eye of three New-Zealand White rabbits (no rinsing). Animals were then observed for 3 days. Ocular irritation was scored by Draize method. The mean scores (24, 48 and 72 hours) are 0.33/0.33/0.33 for chemosis, 0.33/0.33/0.66 for redness, 0/0/0 for iris and 0.33/0.33/0.33 for cornea opacity. These ocular irritation signs were fully reversible after 2 days. The results indicate that the test substance has slight irritant effect in the eye of the rabbit However; no classification is required according to EU criteria.
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