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EC number: 248-096-5 | CAS number: 26896-48-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-guideline study comparable to guideline study with acceptable restrictions; no data on purity of test substance
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Method: other: Federal Register Vol.38, No. 187, 1973. Method used is similar to OECD Guideline 405 (Acute Eye Irritation/Corrosion) with some deviations (no data on test substance purity).
- GLP compliance:
- no
Test material
- Reference substance name:
- Tricyclodecanedimethanol
- EC Number:
- 248-096-5
- EC Name:
- Tricyclodecanedimethanol
- Cas Number:
- 26896-48-0
- Molecular formula:
- C12H20O2
- IUPAC Name:
- [3-(hydroxymethyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]methanol
- Details on test material:
- - Name of test material (as cited in study report): TCD-Alkohol TM
- Physical state: colorless viscous liquid
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF-Albino-Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually caged
- Diet (e.g. ad libitum): compound feeds ERKA 8300 from Robert Koch oHG, Hamm, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: no dat
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (equivalent to approx. 0.1 mL) - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline solution
- Time after start of exposure: 24 hrs
SCORING SYSTEM: according to Table E: Grading of Ocular Lesions in OECD Guideline 405 Acute Eye Irritation/Corrosion)
TOOL USED TO ASSESS SCORE: hand-slit lamp; for examinations following the 24 h reading, fluorescein (0.01% solution) was used for staining.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2, #3, #5, and #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2, #3, #4, #5, and #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3, #5, and #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
Any other information on results incl. tables
Eye Irritating Effect of octahydro-4,7-methano-1H-indenedimethanol (TCD-Alkohol DM)
(undiluted test substance)
Rabbit |
Effect |
Score (hours after application) |
Score (days after application) |
||||||
1 |
7 |
24 |
48 |
72 |
7 |
14 |
21 |
||
1 |
Cornea |
2 |
2 |
2 |
2 |
3 |
2 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Cornea |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Cornea |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Cornea |
2 |
2 |
2 |
2 |
3 |
1 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
Cornea |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
6 |
Cornea |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
2 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
mean scores (rabbits 1-6) of readings at 24hrs/48 hrs/72 hrs :
Cornea: 2 / 2 / 2.3 (max. possible: 4)
Iris: 0 / 0 / 0 (max possible: 2)
Conjunctivae - Redness: 2 / 1.2 / 1 (max. possible: 3)
- Chemosis: 0.7 / 0 / 0 (max. possible: 4)
Reversibility:
The effects subsided within 7 days and were absent 14 days after application.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test substance proved to be irritating to the eye.
- Executive summary:
In a primary eye irritation study, 100 mg (equivalent to approx. 0.1 mL) of octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol TM) was instilled into the conjunctival sac of 6 Himalayan rabbits for 24 hours. After 24 hours eyes were washed with physiological saline solution. Animals then were observed for 21 days. Irritation was scored according to Table E: Grading of Ocular Lesions of OECD test guideline 405 (Acute Eye Irritation/Corrosion).
Irritation reactions of cornea and conjunctivae (redness and chemosis) developed within 1 to 24 hours after application. Effects on cornea had their peak at 72 hours, subsided thereafter and were absent at day 14. Effects on conjunctiva peaked within 24 to 72 hours, subsided thereafter and were not to be observed at days 7 (Hollander/Hoechst AG; 1975b).
In this study, octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol TM) is irritating to the eye based on EU legislation.
This eye irritation study in the rabbit is acceptable. It complies with OECD guideline 405 (Acute Eye Irritation/Corrosion).
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.
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