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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 11-DEC-2006 to 04-jul-2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Grimaud frères selection SAS, La Corbière, Roussay, France
- Age at study initiation: 3 to 4 months old
- Weight at study initiation: 3 +/- 0.15 kg
- Housing : individually in Pajon cages (50*57*75 cm)
- Diet : free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France
- Water : ad libidum (drinking water filtered by a FG Millipore membrane (0.22 micron))
- Acclimation period: at least 5 days before the beginning of the study

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

IN-LIFE DATES : from 09 jan 2007 to 19 jan 2007

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye served as control
Amount / concentration applied:
100 mg
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
- Washing: not rinsed
- Scoring system: OECD and EU guidelines
- Tool used to assess score: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean scores per animals over 24, 48 and 72h
Score:
1 - 2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Scores: 1, 1.7, 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean scores per animal over 24, 48 and 72h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Scores: 2, 2, 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean scores per animal over 24, 48 and 72h
Score:
0.3 - 0.7
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Scores: 0.7, 0.7, 0.3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean scores per animal over 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Scores: 2, 2, 2
Irritant / corrosive response data:
A slight or moderate chemosis and a slight to severe redness of the conjunctiva were observed in all animals from day 1 until day 7.
A clear to whitish purulent discharge were noted in all animals from day 1 until day 3 (2 animals) or 4 (1 animal).
An iritis was noted in all animals between day 1 and day 3.
A slight or moderate corneal opacity, which covered the whole area of the cornea of 2/3 animals on day 2, was recorded in all animals from day 2
until day 4, 5 or 6.

Any other information on results incl. tables

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

1/0/0

3/2/2

2/2/2

24 h

2/2/2

/1/1

2/2/2

1/2/2

48 h

2/2/2

1/1/0

2/2/2

1/2/2

72 h

2/2/2

0/0/0

2/2/2

1/1/2

Average 24h, 48h, 72h

2/2/2

0.7/0.7/0.3

2/2/2

1/1.7/2

Reversibility*)

c

c

c

c

Average time (unit) for reversion

(8 days)

(8 days)

(8 days)

(8 days)

 

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

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
- Interpretation of results: Category 2A (irritating to eyes)
- Criteria used for interpretation of results: EU GHS

SUMMARY:
In a primary eye irritation study (CIT, 2007) 100 mg of Vanilline (pure product) was instilled into the conjunctival sac of right eye of a young adult New Zealand White rabbit (3 males) Animals then were observed for 8 days (period of reversibility). Irritation was scored according to theOECD and EU guidelines.

Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.7 and 2.0 for chemosis, 2.0, 2.0 and 2.0 for redness of the conjunctiva, 0.7, 0.7 and 0.3 for iris lesions and 2.0, 2.0 and 2.0 for corneal opacity.
In this study, Vanilline is irritating to the eye based on the EU classification criteria.

Classification: irritating
Executive summary:

In a primary eye irritation study (CIT, 2007) 100 mg of Vanilline (pure product) was instilled into the conjunctival sac of right eye of a young adult New Zealand White rabbit (3 males). Animals then were observed for 8 days (period of reversibility).  Irritation was scored according to the OECD and EU guidelines.

 

Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.7 and 2.0 for chemosis, 2.0, 2.0 and 2.0 for redness of the conjunctiva, 0.7, 0.7 and 0.3 for iris lesions and 2.0, 2.0 and 2.0 for corneal opacity.

In this study, Vanilline is irritating to the eye based on the EU classification criteria.