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Toxicological information

Eye irritation

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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:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Simplified study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
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

 

*) 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.