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EC number: 271-832-1 | CAS number: 68609-68-7 The complex combination of products produced by the distillation of products from a 2-ethyl-1-hexanol manufacturing process. It consists predominantly of organic compounds such as alcohols, aldehydes, esters, carboxylic acids and acetals having carbon numbers predominantly in the range of C4 through C16 and boiling in the range of 150°C to 308°C (302°F to 586°F).
- 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
Based on key study results, Montanol 800 is considered to be irritating to skin and slightly irritating to eyes.
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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: approximately 12-16 weeks old
- Weight at study initiation: 2.49-2.57 kg
- Housing: individually, in suspended metal cages
- Diet: Rabbit Diet (AW Tindall Limited, Holbeach, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-21 °C
- Humidity: 50-65 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From: 01-Oct-1985 To: 08-Oct-1985 - Type of coverage:
- other: occlusive or semi-occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL of undiluted test item - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (area of gauze patch used)
- Type of wrap if used: gauze patch secured in position with adhesive strapping
REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in ether
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Approximately 1, 24, 48 and 72 hour(s) after patch removal, the test sites were examined and scored acording to the scale of Draize. The scores for erythema and oedema at the 24 and 72 hour readings were totalled for the 3 test rabbits (12 values). This total was divided by 6 to give the Primary Irritation Index of the test item. This index was used to classify the skin irritation according to the scheme shown under "Any other information on materials and methods incl. tables". - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: desquamation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: sum of 24 and 72 hour reading / 6
- Score:
- 2.2
- Remarks on result:
- other: moderate irritant
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information
- Executive summary:
In a primary dermal irritation study (Jones & Collier, 1985), 3 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of ZD 8 Gewaschen for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize (1959). The primary irritation index was used for classification of irritancy.
In this study, ZD 8 gewaschen was a moderate irritant based on well defined erythema accompanied by minimal oedema noted and scored in all rabbits.
Reference
Well defined erythema accompanied by minimal oedema, with the reactions extending beyond the site of application was noted in 3/3 rabbits at the 1 -hour reading and in 2/3 rabbits at subsequent 24, 48 and 72 -hour observations. The skin irritation had become less marked in one rabbit by the 24 -hour reading when barely perceptible erythema was seen in this animal. In addition, desquamation was noted in 2/3 rabbits at this stage. Similar levels of reaction persisted at subsequent 48 and 72 -hour readings. A reduction in the level of reaction was seen at day 7 when barely perceptible erythema accompanied by desquamation, with the reactions extending beyond the site of application was apparent in the remaining animal at this stage.
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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: approximately 12-16 weeks old
- Weight at study initiation: 2.51-2.80 kg
- Housing: individually, in suspended metal cages
- Diet: Rabbit Diet (AW Tindall Limited, Holbeach, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-20 °C
- Humidity: 60-68 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From: 08-Oct-1985 To: 11-Oct-1985 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- Single intraocular application
- Observation period (in vivo):
- 72 hours (terminated as no reactions were apparent)
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- SCORING SYSTEM: Draize (1959) scale for scoring ocular irritation. Using the numerical data obtained a modified version of the system described by Kay & Calandra (1962) was used to classify the ocular irritation potential of the test material.
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 13
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 11
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: group mean score
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: group mean score
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: group mean score
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: group mean score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Executive summary:
In a primary eye irritation study (Jones & Collier, 1985), 0.1 mL of undiluted ZD 8 Gewaschen was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. Animals then were observed for 72 hours following treatment. Irritation was scored by the method of Draize (1959) and the test item was classified for its ocular irritation potential according to Kay & Calandra (1962, modified). The treatment resulted in a maximum mean score of 10 and the test item was classified as a minimal irritant (class 3 on a scale of 1 to 8).
In this study, ZD 8 Gewaschen was a minimal irritant to the rabbit eye.
Reference
No evidence of corneal damage was noted throughout the 72-hour study period. Iridial inflammation was apparent in 2/3 rabbits at the 1-hour reading only. Slight conjunctivitis identified by redness (grade 2) and swelling (grades 1-2) was noted in 3/3 rabbits at the 1-hour reading. The reactions had resolved completely by the 24-hour (1/3 rabbits) or the 48-hour observation (2/3 rabbits). In addition, 0/3 rabbits showed evidence of positive ocular irritation.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary skin irritation study (Jones & Collier, 1985), 3 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of ZD 8 Gewaschen (identical to 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues) for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize (1959). The primary irritation index was used for classification of irritancy. ZD 8 gewaschen was a moderate irritant based on well defined erythema accompanied by minimal oedema noted and scored in all rabbits. The mean erythema score (24, 28 and 72 hour reading) was 1 for animal #1, and 2 for animal #2 and #3. The mean oedema score (24, 48 and 72 hour reading) was 0, 1 and 0.67 for animal #1, #2 and #3, respectively. Mild signs of irritation were still present at the end of the observation period.
In a primary eye irritation study (Jones & Collier, 1985), 0.1 mL of undiluted ZD 8 Gewaschen was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. Animals then were observed for 72 hours following treatment. Irritation was scored by the method of Draize (1959) and the test item was classified for its ocular irritation potential according to Kay & Calandra (1962, modified). In this study, ZD 8 Gewaschen was a minimal irritant to the rabbit eye.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Based on the results of the skin and eye irritation key toxicity studies. 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues is classified and labelled for skin irritation / corrosion according to Directive 67/548/EEC as R38, irritating to skin and according to Regulation 1272/2008/EC as Cat. 2, H315, causes skin irritation.
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.