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EC number: 701-326-2 | CAS number: -
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1989-02-10 to 1989-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 405 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- EC Number:
- 229-861-2
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- Cas Number:
- 6790-58-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan
- Reference substance name:
- (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan
- Cas Number:
- 234431-64-2
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan
- Reference substance name:
- (3aR,5aS,9aS,9bS)-3a,6,6,9a-tetramethyldodecahydronaphtho[2,1-b]furan
- Cas Number:
- 68365-89-9
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aR,5aS,9aS,9bS)-3a,6,6,9a-tetramethyldodecahydronaphtho[2,1-b]furan
- Reference substance name:
- (3aS,5aR,9aR,9bR)-Dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- Cas Number:
- 2006270-65-9
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aS,5aR,9aR,9bR)-Dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- Test material form:
- solid
- Details on test material:
- - Physical state: pale yellow liquid or white solid
- Stability under test conditions: stable
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: M: 15 weeks; F: 16 weeks
- Weight at study initiation: M: 2.7 kg; F: 2.6-2.9 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 42/88 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Itingen ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:1989-02-10 To: 1989-02-21
Test system
- Vehicle:
- other: undiluted or in Neantine
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Left eye: 0.1 g (undiluted) / Right eye: 0.1 mL (diluted into 30 % in Neantine) - Duration of treatment / exposure:
- Eyes were not rinsed
- Observation period (in vivo):
- Eyes were observed 1, 24, 48, 72 hours and 7 days after administration
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure:
SCORING SYSTEM: Draize scale according to the OECD test guideline No. 405
TOOL USED TO ASSESS SCORE: slit-lamp and diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- See Table 7.3.2/1
- Other effects:
- none
Any other information on results incl. tables
Table 7.3.2/1: Mean irritant/corrosive response data of each animal at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea opacity(/4) |
Iris (/2) |
Conjunctivae |
|
Redness (/3) |
Chemosis (/4) |
|||
1 h |
0/0/0 |
0/0/0 |
2/2/2 |
1/0/1 |
24 h |
0/0/0 |
0/0/0 |
1/1/2 |
0/0/1 |
48 h |
0/0/0 |
0/0/0 |
0/0/2 |
0/0/1 |
72 h |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
Mean 24-48-72 hrs |
0.0/0.0/0.0 |
0.0/0.0/0.0 |
0.33/0.33/1.67 |
0.00/0.00/0.67 |
Reversibility*) |
- |
- |
c. |
c. |
Average time (unit) for reversion |
|
|
7 days |
72 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of undiluted Fixambrene was instilled into the left eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The left eye of each rabbit was instilled with 0.1 mL Fixambrene diluted at 30 % in Neantine. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
The calculated mean score for each individual lesion for each animal treated with undiluted Fixambrene within 3 scoring times (24, 48 and 72 h) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions.
The effects observed were all reversible within 7 days.
Under the test conditions, Fixambrene is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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