Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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)
- 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 - 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
- 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 - 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.
- 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.
Reference
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) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- 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)
- 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 - 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 - 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 - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.