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EC number: 248-570-1 | CAS number: 27610-92-0
- 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
The results of the skin irritation study according to OECD 404 indicate that the target substance and Category Member 2, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item. That result is supported by a skin irritation study on the Category Member 3, 2-decyltetradecanoic acid.
The results of the eye irritation study according to OECD 405 indicate that the target substance and Category Member 2, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item. That result is supported by an eye irritation study on the Category Member 3, 2-decyltetradecanoic acid.
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
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Strain: New Zealand White
- Sex: female
- Source: Charles River Italia S. p. A. (Como), Italy (supplier), P. O. A. D. A., Mandello Lario (Como),Italy (breeder)
- Age: 9 – 11 weeks
- Weight at study initiation: 1.8 – 2.3 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent area of untreated skin
- Amount / concentration applied:
- - Total volume applied: 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test article was applied undiluted.
- Area of exposure: The test substance was applied to a gauze patch (2.5 cm x 2.5 cm). The patch was placed on the appropriate test field. A strip of aluminium foil was placed over the treated site and the whole trunk was wrapped with an elastic adhesive bandage.
- Occlusion: semi-occlusion
- Vehicle: none
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: After 4 hours exposure the bandage and patch were taken off and the test substance was removed by gentle swapping of the skin with cotton wool soaked in water at approximate body temperature.
EXAMINATIONS
- Scoring system: according to OECD 404
- Examination time points: Skin reactions were read immediately and 1, 24, 48 and 72 hours as well as 7 and 14 days after the end of the exposure period - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Desquamation after 7 d, reversible after 14 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Desquamation reversible after 14 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Desquamation reversible after 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: desquamation
- Basis:
- other: all animals
- Time point:
- other: day 7
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- No irritation was observed in any animal approximately 1 hour following the 4 hour period of exposure. Very slight erythema (score of 1) was observed in all animals at the subsequent 24 and 48 hour examinations, remaining in 2 animals at the 72 hour examination. Desquamation was noted in all 3 animals after 7 days. Recovery had occurred within 14 days.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.
- Executive summary:
The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Strain: New Zealand White
- Sex: female
- Source: Charles River Italia S. p. A. (Como) (supplier), P.O.A.D.A. Mandello Lario (CO) (breeder), Italy
- Age: 9 to 11 weeks
- Weight at study initiation: 1.8 - 2.3 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye
- Amount / concentration applied:
- - Amount of substance instilled: 0.1 ml
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test substance was applied undiluted.
- Amount of substance instilled: 0.1 ml
- Vehicle: none
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: Ocular reactions were assessed. After 24 h exposure the eyes were examined additionally after instillation of Fluorescein and irrigation with 20 ml 0.9% sodium chloride solution using UV light.
- Scoring system: according to OECD 405
- Observation period: Ocular reactions were recorded 1, 24, 48 and 72 h after application.
- Tool used to assess score: not mentioned - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Well defined conjunctival redness, chemosis and ocular discharge in all three animals one hour after application which remained in one animal at the 24 hours examination. In the remaining two animals slight redness, chemosis and discharge were oserved at the 24 hour reading. At the 48 hour examination only slight conjunctival redness was observed in two animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.
- Executive summary:
The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The results of the skin irritation study according to OECD 404 indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.
The results of the eye irritation study according to OECD 405 indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.
Effects on skin
irritation/corrosion: slightly irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
According to the classification criteria of regulation (EC) 1272/2008 2 -butyloctanoic acid has not to be classified neither as skin irritant nor eye irritant.
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.
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