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EC number: 266-885-2 | CAS number: 67674-46-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6,6-dimethoxy-2,5,5-trimethylhex-2-ene
- EC Number:
- 266-885-2
- EC Name:
- 6,6-dimethoxy-2,5,5-trimethylhex-2-ene
- Cas Number:
- 67674-46-8
- Molecular formula:
- C11H22O2
- IUPAC Name:
- 6,6-dimethoxy-2,5,5-trimethylhex-2-ene
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unknown
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): HR 02/197007
- Physical state: colourless to slight yellowish liquid
- Lot/batch No.: 000003
- Expiration date of the lot/batch: 31 December 2002
- Storage condition of test material: dark, cold and dry
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino Chbb:HM(SPF) - Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, Biberach, Germany
- Weight at study initiation: 2.6 - 3.3 kg
- Housing: individually in PPO cages
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123" from Altromin, Lage, Germany, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 April 2002 To: 28 April 2002
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 20 mL 0.9 % sodium chioride solution
- Time after start of exposure: 24 h
SCORING SYSTEM: See table 7.3.3/1
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2186/2.6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2186/2.6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2186/2.6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2102/3.3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2102/3.3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2102/3.3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2106/3.2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2106/3.2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2106/3.2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2107/2.8
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2107/2.8
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2107/2.8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2186/2.6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2186/2.6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2186/2.6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2102/3.3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2102/3.3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2102/3.3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2106/3.2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2106/3.2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2106/3.2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2107/2.8
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2107/2.8
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2107/2.8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2186/2.6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2186/2.6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2186/2.6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2102/3.3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2102/3.3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2102/3.3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2106/3.2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2106/3.2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2106/3.2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2107/2.8
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2107/2.8
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2107/2.8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: 2186/2.6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2186/2.6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2186/2.6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2102/3.3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2102/3.3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2102/3.3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2106/3.2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2106/3.2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2106/3.2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2107/2.8
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2107/2.8
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 2107/2.8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- See Table 7.3.2/2
Any other information on results incl. tables
Table 7.3.2/2: detailed results
Animal n°/weight (kg) |
Ocular lesions |
Score at timepoint |
Individual mean score |
|||
1 h |
24 h |
48 h |
72 h |
|||
2186/2.6 |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
1 |
1 |
1 |
0 |
0.67 |
|
Chemosis |
2 |
1 |
0 |
0 |
0.33 |
|
2102/3.3 |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
1 |
1 |
1 |
0 |
0.67 |
|
Chemosis |
1 |
1 |
0 |
0 |
0.33 |
|
2106/3.2 |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
1 |
1 |
1 |
0 |
0.67 |
|
Chemosis |
1 |
1 |
0 |
0 |
0.33 |
|
2107/2.8 |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
1 |
1 |
1 |
0 |
0.67 |
|
Chemosis |
1 |
1 |
0 |
0 |
0.33 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions, HR 02/197007 is not irritating to eyes and should not be classified for eye irritation according to the criteria of directive n°67/548/EEC and CLP regulation (EC) n°1272/2008.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 4 healthy adults female albino rabbits were exposed to 0.1 mL of undiluted HR02/197007 in one eye while the other eye corresponded to the control. The eyes were examined and scored unwashed after 1 h and 24 h and then washed with 20 mL 0.9% sodium chloride solution. Changes were observed at 48 and 72 hours after dosing and graded.
The individual mean score for all animals were 0 for cornea opacity, 0 for iris lesion, 0.67 for conjunctiva and 0.3 for chemosis. All effects were reversible within 72 h.
Under these test conditions, HR 02/197007 isconsidered as not irritating to eyes and should not be classified according to the criteria of directive 67/548/EEC and CLP regulation (EC) n°1272/2008.
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