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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:
From may 2003 to 05 sept 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-ethoxy-4-hydroxybenzaldehyde
EC Number:
204-464-7
EC Name:
3-ethoxy-4-hydroxybenzaldehyde
Cas Number:
121-32-4
Molecular formula:
C9H10O3
IUPAC Name:
3-ethoxy-4-hydroxybenzaldehyde

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 3 +/- 0.4 kg
- Housing: individually in polystyrene cages (48.2*58*36.5 cm)
- Diet (e.g. ad libitum): free access to 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: at least 5 days before the start of the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h / 12h


IN-LIFE DATES: From: 03 jun 2003 To: 17 jun 2003

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE: not rinsed
SCORING SYSTEM: according to the Commission Directive 2004/73/EC
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 6 days

Any other information on results incl. tables

Eye 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

0/0/0

0/0/0

2/3/3

3/3/3

24 h

2/1/1

1/0/0

3/2/2

3/2/3

48 h

2/1/1

1/0/0

3/1/1

2/1/1

72 h

0/1/0

1/0/0

2/0/1

2/1/0

Average 24h, 48h, 72h

1.3/1/0.7

1/0/0

2.7/1/1.3

2.3/1.3/1.3

Reversibility*)

c

c

c

c

Average time (unit) for reversion

5 days

5 days

7 days

6 days

 

*) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Classified irritating according to CLP regulation.


Executive summary:

In one primary eye irritation study of validity 1 (Klein, 2003), 100 mg of ethylvanillin was instilled into the conjunctival sac of left eye of young adult New Zealand White rabbits (3 animals). Eyes were not rinsed and the right eye served as control. Animals then were observed for 7 days.

Irritation was scored by the method according to the Commission Directive 2004/73/EC. Mean scores calculated for each animal over 24, 48 and 72 hours were 2.3, 1.3 and 1.3 for chemosis, 2.7, 1 and 1.3 for redness of the conjunctivae, 1, 0 and 0 for iris lesions and 1.3, 1 and 0.7 for corneal opacity.

In this study, ethylvanillin was slightly eye irritant and based on the EU classification criteria (1272/2008) it should be classified as Eye irri. category 2 (H319).

It is not classified according to the 67/548/EC directive criteria.