Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-465-2 | CAS number: 121-33-5
Eye irritation
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:
- guideline 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:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Vanillin
- EC Number:
- 204-465-2
- EC Name:
- Vanillin
- Cas Number:
- 121-33-5
- Molecular formula:
- C8H8O3
- IUPAC Name:
- 1-butoxypropan-2-ol
Constituent 1
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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- 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:
- Category 2A (irritating to eyes) based on GHS criteria
- 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 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.
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 tis study, Vanillin is irritating to the eye based on EU classification criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
