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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from NTRL report

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
FINAL REPORT OF SEVERAL STUDIES ON VANILLIN WITH COVER LETTER DATED 112191
Author:
NTRL (National Technical Reports Library)
Year:
1991
Bibliographic source:
NTRL (National Technical Reports Library); OTS05343EA; 22 NOVEMBER 1991
Reference Type:
secondary source
Title:
SIDS INITIAL ASSESSMENT REPORT- Vanillin
Author:
OECD SIDS
Year:
1996
Bibliographic source:
SIDS INITIAL ASSESSMENT REPORT- Vanillin; OECD SIDS; 28/10/1996.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An eye irritation test of Vanillin (CAS No: 121-33-5) was performed in six New Zealand White rabbits to assess its eye irritation potential.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Vanillin
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: organic
- Physical state: Solid
-Smiles: c1(cc(ccc1O)C=O)OC
-InChI: 1S/C8H8O3/c1-11-8-4-6(5-9)2-3-7(8)10/h2-5,10H,1H3
Specific details on test material used for the study:
- Name of test material (as cited in study report): Vanillin
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: organic
- Physical state: Solid
-Smiles: c1(cc(ccc1O)C=O)OC
-InChI: 1S/C8H8O3/c1-11-8-4-6(5-9)2-3-7(8)10/h2-5,10H,1H3

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand Black
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
500mg (0.1ml)
Duration of treatment / exposure:
24 hours



Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Federal Hazardous Substances Act (FHSA)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
18.8
Max. score:
110
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Mild irritating effects were observed.

Any other information on results incl. tables

EYE IRRITATION SCORES

Hours

1

24

48

72

120

168

Structure

Cr

Ir

Con

Cr

Ir

Con

Cr

Ir

Con

Cr

Ir

Con

Cr

Ir

Con

Cr

Ir

Con

Animal no.

1

0

0

10

10

5

14

5

5

12

0

0

8

0

0

2

0

0

0

2

0

0

10

5

0

14

5

0

12

0

0

8

0

0

2

0

0

0

3

0

0

14

20

5

16

20

5

12

10

0

8

5

0

4

0

0

0

4

0

0

10

5

0

12

5

0

12

0

0

8

0

0

2

0

0

0

5

0

0

10

10

5

16

10

5

12

0

0

8

0

0

4

0

0

0

6

0

0

10

5

0

10

5

0

10

0

0

2

0

0

0

0

0

0

Mean score

10.6

25.3

22.5

8.6

3.1

0.0

Cr- cornea, Ir- iris,  Con-Conjunctivae

Immediate: Discomfort was moderate with eyes tightly closed

Comments: 10 min: Slight to moderate erythema; very slight to slight edema

1 Hr.: slight to moderate erythema ; very slight to slight edema

24 Hr.: area of barely perceptible corneal dullness, iris reaction to light was sluggish, moderate to severe erythema very slight to slight edema, copious discharge containing much whitish exudates.

48 - 120 Hr.: Gradually improvement.

168 Hr.: All scored zero.

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The chemical Vanillin (CAS No: 121-33-5) was considered to be mildly irritating to the eyes of six New Zealand White rabbits.
Executive summary:

An eye irritation test of Vanillin (CAS No: 121-33-5) was performed in six New Zealand White rabbits to assess its eye irritation potential.

 

The Vanillin was applied as finely ground powder at a dose equivalent to 55 mg (0.1 ml) for 24 hours and reactions were scored at 24 , 48 and 72 hours according to Federal Hazardous Substances Act (FHSA).

 

Mild irritating effects were observed with the irritation score of 18.8 (out of maximum score of 110). All scored zero after 168 hours.

 

Since the chemical caused slight discomfort and ocular lesions during the 72 hours observation period, the chemical Vanillin (CAS No: 121-33-5) was considered to be mildly irritating to the eyes of six New Zealand White rabbits