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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 01 jun 2006 to 16 jan 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

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:
yes
Remarks:
Age and body weights of animals are not the same as those described in protocol
GLP compliance:
yes

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:
TEST ANIMALS
- Sex: female
- Source: CEGAV breeding establishment - Les Hautes Noës, St Mars d'Egrenne, 61350 Passais la Conception (France).
- Age at study initiation: between 19 and 22 weeks old
- Weight at study initiation: between 3.9 and 4.1 kg
- Housing: individually in cages of standard size (635*435*335 mm).
- Diet: SDS/DIETEX STANRAB (P) SQC feed distruted daily at fixed time
- Water: drinking water (analysed every 6 months with a certificate), ad libitum
- Acclimation period: at least 5 days before the treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21°C
- Humidity (%): 45-65%
- Air changes: 10 times per hours
- Photoperiod (hrs dark / hrs light): 12/12 (light on at 7.30 a.m.)

IN-LIFE DATES: From: 05 jun 2006 To: 26 jun 2006

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye served as control
Amount / concentration applied:
TEST SYSTEM:
- Amount/concentration applied: 0.1 ml
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
Comment: not rinsed
- Scoring system: in accordance with the OECD guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 1 hour
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.55
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Reversibility:
fully reversible within: 15 days
Other effects:
After instillation, all animals presented obvious swelling with partial eversion of the lids, added to a lacrimation with the moistening of the eyelids and of fur around eyelids. At this time, some blood vessels definitely hyperaemic (injected) was noted in any animals.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

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

1/1/1 

 2/2/2

24 h

0/0/0

0/0/0

 2/1/2

 2/1/2

48 h

0/0/0

0/0/0

 1/1/3

1/1/4 

72 h

0/0/0

0/0/0

 0/1/2

 0/1/2

Average 24h, 48h, 72h

0/0/0 

 0/0/0

 1.66/1/2.33

 1/1/2.67

Reversibility*)

 -

-

 c (15 days)

 c (15 days)

 

*) Reversibility: c. = completely reversible.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Based on this test, the substance is slightly irritating and not classified according to GHS EU criteria.





Executive summary:

In a primary eye irritation study (CERB, 2006), 0.1 ml of gaiacol (99.6% of purity) was instilled into the conjunctival sac of left eye of adult New Zealand White rabbits (female). Eyes were not rinsed and the other eye served as control.
Animals then were observed for 14 days.
  Irritation was scored by the method in accordance with EU and OECD guidelines.
In this study, gaiacol is slightly irritating.

However, guaiacol is officialy classified as Eye irritation category 2 (H319: Causes serious eye irritation) according to annex VI table 3 of the Regulation (EC) n°1272/2008.