Registration Dossier
Registration Dossier
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EC number: 201-964-7 | CAS number: 90-05-1
Eye irritation
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:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Guaiacol
- EC Number:
- 201-964-7
- EC Name:
- Guaiacol
- Cas Number:
- 90-05-1
- Molecular formula:
- C7H8O2
- IUPAC Name:
- Phenol
Constituent 1
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.
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