Registration Dossier
Registration Dossier
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EC number: 451-160-7 | CAS number: 17913-76-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01.10.2001 - 15.10.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4,7,9-tetramethyldecane-4,7-diol
- EC Number:
- 451-160-7
- Cas Number:
- 17913-76-7
- Molecular formula:
- C14H30O2
- IUPAC Name:
- 2,4,7,9-tetramethyldecane-4,7-diol
- Details on test material:
- Lot#18197-D-5
2,4,7,9-Tetramethyl-4,7-decanediol
CAS# 17913-76-7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 0,1 ml initial instillation
- Observation period (in vivo):
- 1, 24, 48, 72 hours and on days 7 and 14
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: mini-Maglite
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge
|
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
60 min |
0h/0/0 |
0/0/0 |
1/2/2 |
2/3/3 |
2/2/2 |
24 h |
0h/0h/0h |
1/1/1 |
2/2/2 |
2/3/2 |
2/2/2 |
48 h |
0h/2/0h |
0/1/0 |
2/2/2 |
2/3/2 |
1/2/2 |
72 h |
0/2/0 |
0/1/0 |
2/2/1 |
2/2/1 |
1/2/1 |
7 d |
0/0/0 |
0/0/0 |
1/1/1 |
0/1/0 |
0/1/0 |
14 d |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/1.3/0 |
0.3/1/0.3 |
2/2/1.7 |
2/2.7/1.7 |
1.3/2/1.7 |
h = lack of normal luster
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- 2,4,7,9-tetramethyldecane-4,7-diol is an ocular irritant, but not corrosive.
- Executive summary:
Ocular findings:
Corneal opacity was noted in 1/3 eyes, although fluorescein stain retention was noted in all the eyes.
The opacity cleared by day 7.
Iritis, noted in 3/3 eyes, cleared by day 7. Conjunctival irritation, noted in 3/3 eyes, cleared by day 14.
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