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EC number: 266-885-2 | CAS number: 67674-46-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2002-03-18 to 2002-04-09
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- 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:
- Test article: HR 02/197007
Chemical name: 2-Hexene, 6,6-dimethoxy-2,5,5-trimethyl-
CAS No.: 0067674-46-8
Test article name for report: HR 02/197007
Batch No.: 000003
Test concentration (v/v): 100 %, 50 %, 25 %, 10 %, 1 %, 0 % (vehicle)
Description of test article: colourless to slight yellowish, liquid
Arrival of test article: 27th February 2002
Expiration date: 31s t Dec. 2002
Storage of test article: dark, cool and dry
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino Chbb:HM(SPF) - Littlerussian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, Biberach, Germany
- Weight at study initiation: between 2.7 and 2.9 kg bw
- Housing: kept in individual box provided with filtered air
- Acclimation period: 7 days
- Diet (e.g. ad libitum): Altromin 2123 supplied from Altromin, D-32791 Lage, Germany, ad libitum
- Water (e.g. ad libitum): bottles with domestic quality drinking water acidified with hydrochloric acid to pH2.5, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 17 and 23
- Humidity (%): between 40 and 70
- Air changes (per hr): at least 10 cycles
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: ethanol/diethylphthalat 1:1
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted, 50%, 25%, 10%, 1%, 0% (vehicle) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
- Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Type of wrap if used: semi occlusive with adhesive Gothaplast tape (2.5 cm width) and fixed with Gothaplast tape (5 cm width) around the trunk
- Area of exposure: approximately 10*10 cm
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
- Washing (if done): skin was cleaned with mild soap and lukewarm water
SCORING SYSTEM:
See table 7.3.1/1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 2224
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2224
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2224
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2240
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2240
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2240
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2245
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2245
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2245
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2246
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2246
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- erythema score
- Basis:
- animal: 2246
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2224
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2224
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2224
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2240
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2240
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2240
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2245
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2245
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2245
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2246
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2246
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritation parameter:
- edema score
- Basis:
- animal: 2246
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 14
- Remarks on result:
- other: undiluted
- Irritant / corrosive response data:
- Application of the test substance HR 02/197007, was associated with a well-defined erythema and a well-defined oedema 24 h after application. The reactions were totally reversible by the 21st day of the test. Skin recovered a normal aspect between the 14th and 21st day of the test.
Any other information on results incl. tables
Table 7.3.1/2: Individual and average scores after 4-hour exposure
|
1: after termination of exposure 2: only the scores from the readings after 24 hours, 48 hours and 72 hours are included in the calculation of the individual values AL: anterior left test filed = 100% ML: middle left test field = 50% PL: posterior left test field = 25% AR: anterior right test field = 10% MR: middle right test field = 1% PR: posterior right test field = 0% (vehicle) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- HR 02/197007 should be classified as irritating to skin according to the criteria of directive 67/548/EEC and category 2 according to CLP regulation (EC) n°1272/2008.
- Executive summary:
A dermal irritation study was conducted according to OECD guideline 404 in compliance with GLP. Four healthy adult New Zealand white rabbits were exposed to 0.5 mL/rabbit of HR 02/197007 on clipped skin of the dorsal area for 4 hours in semi-occlusive conditions. Skin reactions were observed at 1, 24, 48 and 72 h after removal of the substance until day 21.
With undiluted test article, 1 hour after patch removal there was a well-defined erythema and a well-defined oedema in all animals. Mean individual scores for 24, 48 and 72 h observation time points were 2.33, 2.33, 2.33 and 2.00 for erythema and 2.33, 2.33, 2.33 and 1.67 for oedema. The reactions were reversible within 21 days for all animals. The skin recovered a normal aspect between the 14th and the 21st day of the test.
HR 02/197007 should be classified as irritating to skin according to the criteria of directive 67/548/EEC and category 2 according to CLP regulation (EC) n°1272/2008.
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