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EC number: 203-982-0 | CAS number: 112-53-8
- 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
The key study for skin irritation was guideline study carried out in humans and found the test substance not irritating to skin (Henkel 1996; rel 1). The test procedure was in accordance with generally accepted scientific standards and described in sufficient detail, in compliance with GLP.
In the first in vivo eye irritation study in rabbits, which was conducted according to a protocol similar to OECD Test Guideline 405 but prior to GLP, the test material, dodecan-1-ol, was concluded to be irritating to rabbit eye (Scientific Associates 1975; rel 2).
In the second in vivo eye irritation study in rabbits, conducted according to OECD Test Guideline 405 and in compliance with GLP, concluded the test material, dodecan-1-ol, to be not irritating to eyes (Safepharm Laboratories, 1996; rel. 1).
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:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (based on)
- GLP compliance:
- yes
- Species:
- human
- Strain:
- other: n/a
- Details on test animals or test system and environmental conditions:
- Age of the subjects was 22 - 53 years with an average of 34.9 years.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application.
- Number of animals:
- 20
- Details on study design:
- 15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n/a
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n/a
- Irritation parameter:
- erythema score
- Basis:
- other: human #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- other: human #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- other: human #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: human #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: human #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: human #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The substance was not irritating.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The undiluted alcohol dodecanol did not produce any skin irritation in human vounteers following a 4 hour semi-occlusive exposure in a test based on OECD 404.
Reference
No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually housed in metal cages elevated above the droppings
- Diet: Purina rabbit chow, ad libitum
- Water: tap water, ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): unspecified
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours (single instillation, not washed)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 26.7
- Max. score:
- 20
- Remarks on result:
- other:
- Remarks:
- Mild to moderate erythema of the palpebral and bulbar conjunctivae , mild to moderate chemosis, mild mucoid discharge and a mild to moderate corneal opacity involving one-fourth to three-fourths of the corneal surface. By 72 hours, all test eyes showed improvement in the parameters of irritation in all but one animal.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 40
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 33.33
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 15
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 11.66
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 40
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 15
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 11.33
- Max. score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4.66
- Max. score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 6
- Max. score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4.66
- Max. score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 6.66
- Max. score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis scores not reported
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis scores not reported
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis scores not reported
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis scores not reported
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis scores not reported
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis scores not reported
- Irritant / corrosive response data:
- Mild to moderate erythema of the palpebral and bulbar conjunctivae , mild to moderate chemosis, mild mucoid discharge and a mild to moderate corneal opacity involving one-fourth to three-fourths of the corneal surface. By 72 hours, all test eyes showed improvement in the parameters of irritation in all but one animal. That one animal became worse and even developed mild iritis.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The data suggests that if interpreted in terms of EU criteria, the test substance would be a category 2 eye irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Perciva; Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.53-2.87kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet (ad libitum), (Special Diets Services Ltd., Witham, Essex, UK)
- Water: Mains drinking water (ad libitum)
- Acclimation period: Minimum of 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 45-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- other: warmed to 40C before instillation
- Controls:
- other: The other eye of each animal served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- A single instillation.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours.
- Number of animals or in vitro replicates:
- 3, male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed.
SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" Kay & Callandra (modified).
TOOL USED TO ASSESS SCORE: Light source from a standard opthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Conjunctival discharge was noted in all animals one hour after instillation. No corneal or iridial effects were noted suring the study. Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in the remaining treated eye one hour after treatment. Minimal conjunctival redness was noted in one treated eye at the 24 hour observation point. The test material produced a maximum group mean score of 8.7. Classified as a minimal eye irritant according to Kay & Callandra (modified).
- Other effects:
- All scores were 0 at 48 and 72 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Kalcol 2098 is not irritating to the rabbit eye using either EU or GHS criteria.
Referenceopen allclose all
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
4/6/4/6/6/4 |
24 h |
5/30/30/20/5/20 |
0/0/0/0/0/0 |
4/10/10/10/8/8 |
48 h |
0/30/10/10/0/20 |
0/0/0/0/0/0 |
4/10/10/10/4/8 |
72 h |
0/40/5/5/0/5 |
0/5/0/0/0/0 |
2/14/4/8/2/4 |
Average 24h, 48h, 72h |
13.05 |
0.3 |
7.2 |
AVERAGE SCORE (24+48+72 hour)
- Cornea: All 0
- Iris: All 0
- Conjunctivae (Redness): Individual scores 2 rabbits 0 the remaining rabbit 0.3. (group mean score 0.1)
- Conjunctivae (Chemosis): All 0
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key skin irritation study is further supported by two high reliability studies in rabbit (Safepharm Laboratories 1996; rel 1, Safepharm Laboratories, 1997; rel 1), and another 1-hour study in human (Henkel 1996; rel 2). The supporting studies provide strong evidence for the fact that dodecan-1-ol is not irritating to skin. Human evidence also suggests dodecan-1-ol not to be irritating by skin contact. A comparative 24-hour semi-occluded human skin patch study by Kaestner (1977) reported only slight, readily reversible irritation in humans. It should be noted that results from Kaestner’s comparative study suggests the percutaneous irritative effects of dodecan-1-ol to be more pronounced in rabbits than man.
In the first in vivo eye irritation study in rabbits, which was conducted according to a protocol similar to OECD Test Guideline 405 but prior to GLP, the test material, dodecan-1-ol, was concluded to be irritating to rabbit eye (Scientific Associates 1975; rel 2). Following a single instillation of undiluted test material into the eyes of 6 rabbits, mild to moderate erythema of the palpebral and bulbar conjunctivae, mild to moderate chemosis, mild mucoid discharge and a mild to moderate corneal opacity involving one-fourth to three-fourths of the corneal surface were observed. By 72 hours, all test eyes showed improvement in the parameters of irritation in all but one animal. That one animal became worse and developed mild iritis.
In the second in vivo eye irritation study in rabbits, conducted according to OECD Test Guideline 405 and in compliance with GLP, concluded the test material, dodecan-1-ol, to be not irritating to eyes (Safepharm Laboratories, 1996; rel. 1). Following a single instillation of 0.1 ml undiluted test material into the eyes of 3 male rabbits, conjunctival discharge was noted in all animals at 1 hour after instillation. No corneal or iridial effects were noted during the study period and observations made at 1, 24, 48 and 72 hours. Moderate conjunctival irritation was noted in the eyes of two animals and minimal conjunctival irritation was noted in the eye of the third animal at 1 hour after treatment. All effects seen at 1 hour were fully reversible by 24 hours. Minimal conjunctival redness was noted in one animal at the 24-hour observation point.
The irritation data for the C10 and C14 alcohols which were concluded to be irritating to eyes (Category 2), suggests that dodecan-1-ol (C12) is also likely to be irritating to eyes and the results of the more recent study by Safepharm Laboratories (1996) are likely to be a result of biological variation in the test. Therefore, dodecan-1-ol is considered to be irritating to eyes.
A full discussion of the Category and considerations of RAAF Assessment Entities can be found in the Human Health Alcohols C6-24 Category report (PFA, 2016).
Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:
Animal studies in the lower members of both the linear alcohols and the UVCBs (C6-11) have a skin irritancy potential ranging from mild to irritant, whereas alcohols in the range of C12 and C16 are graded as mild, essentially non-irritant. Alcohols with a carbon chain length C18 and above demonstrated no skin irritation potential. However, comparative studies in different species demonstrate the increased sensitivity of rabbit as a test species to aliphatic alcohols compared to man (Kaestner, 1977; Motoyoshi et al., 1979). Read across from this study has been used consistently across the LCAAs category for linear and UVCB substances, and no classification is proposed for skin irritation based on category trend of lack of irritant effects in humans despite positive data from animal studies. Longer-chain linear alcohols in pure form, which are in a solid state at standard temperature, are produced in powder form as well as liquids or pastes in some cases. Powders can cause a transient eye irritation and trigger eye classification. This was recognised by the Directive 67/548/EEC classification criteria to the extent that if an irritation response is observed with a powder but not with a paste or liquid, the classification was discounted as a physical effect. However, under the CLP Regulation (Regulation (EC) No 1272/2008) criteria, this difference has been eliminated and irritation as a result of testing with powders triggers a positive classification. The nature of UVCBs means that they can only be manufactured as liquid or amorphous forms; so UVCB alcohols are commercially supplied as pastes only. This phenomenon is the reason for some differences between eye irritation classifications for UVCB alcohols compared to the linear constituents in pure form. Studies with Alcohols, C7-9 have provided evidence that this substance is classified as Eye irritant Category 2, despite the physical form of the substance. This is thought to be consistent with the category trend that shorter chain lengths are more toxic, and hence more irritant, than longer chain lengths. There is substantial experimental evidence that Alcohols, C9-11 and Alcohols, C9-11-branched and linear are not eye irritants. Therefore, even though this substance has the potential of being classified, the studies conducted with this substance underline that this is not the case. The UVCB LCAAs with chain lengths above C12-13 do not require classification for eye irritation. In the case of the single-constituent linear LCAAs of the chain length between C6-C14, category 2 classification as eye irritant is proposed, whereas linear alcohols of chain length between C15-C24 are deemed not irritating. C14 is an exception due to a positive test result determined with a powder test sample; tetradecan-1-ol is therefore classified Category 2 eye irritant under CLP. Data supporting respiratory irritation of the linear and essentially linear LCAAs is not sufficient to trigger classification via this route.
Respiratory irritation and the basis of DNEL for inhalatory local effects
The registrant has referred to the AGW values for several linear and essentially-linear aliphatic alcohols, established by the German regulatory authority. These have been extrapolated from a concentration of octan-1-ol at which respiratory irritation levels had been found to be low/acceptable. The threshold value is 20 ppm, which appears to derive from the 2-ethylhexanol test results from Van Thriel et al. (2003). No additional assessment factors have been applied. Respiratory irritation effects from three separate published papers were cited in reference to this, which the registrant has evaluated and drawn the following overview conclusions: 1. The extrapolation has been made based on molecular weight correction i.e. making the assumption that the equivalent effect would be caused by the equivalent ppm concentration. The value for dodecan-1-ol (derived in the AGW paper) is 155 mg/m³. 2. The studies are concerned with local effects, not systemic effects. 3. The effects investigated were self-reported symptoms/changes, and physiological responses that do not necessarily indicate harm or damage. 4. In view of the non-standard test design, subjective assessment of results, and lack of evidence to connect the reported effects with evidence of harmfulness, these results cannot be considered to be key data. The summary is included for completeness only. The approaches and findings from the three studies (in brief) are as follows.
C. van Thriel, A. Seeber, E. Kiesswetter, M. Blaszkewicz, K. Golka, G.A. Wiesmüller (2003). Physiological and psychological approaches to chemosensory effects of solvents. Toxicology Letters 140-141 (2003) 261-271 - Both 2-Ethylhexanol and octan-1-ol were examined in this study. The AGW ultimately derives from the high-concentration exposure of 2-ethylhexanol. - In additional to self-reported symptoms, physiological measurements (including anterior active rhinomanometry and biochemical analysis of nasal secretions (lavage)) were also investigated and compared with the subjective scores. The physiological responses studied are not necessarily indicative of damage. - 24 subjects exposed for up to 4 hours at “high” min/max octanol concentrations of 0.4/12.5 ppm (mean 6.4 ppm). Lower ranges also tested. - Min/max “high” 2-ethylhexanol concentrations were 1.76/42.07 ppm (mean 21.88 ppm). Lower ranges also tested. - No information is given in the paper regarding the method for generating the dose or whether it would have comprised vapour or aerosol. - Statistical analysis was done - Based on the effects reported, the concentration(s) examined do not result in high scores for chemosensory irritation. - The subjective (self reported) and objective (physiological) responses did not correlate strongly. - This paper is in a relevant and peer reviewed journal (3 months elapsed between being submitted and published)
Andreas Seeber, Christoph van Thriel, Katja Haumann, Ernst Kiesswetter, Meinolf Blaszkewicz, Klaus Golka (2002). Psychological reactions related to chemosensory irritation. Int Arch Occup Environ Health (2002) 75: 314–325: - 8 substances were investigated, including octan-1-ol, at up to 12 ppm. - The paper is primarily concerned with the investigation of chemosensory irritation based on perceived symptoms and self-reported changes of well-being - i.e. not measured physiological responses. As such the paper is not an investigation into “safe” (inhalatory) concentrations of the substances investigated. These are local and not systemic effects. - For octanol, 24 volunteers were exposed for periods up to 4 hours at peak concentrations of up to 12 ppm. Based on the effects reported, the concentration(s) examined do not result in high scores for chemosensory irritation. - No information is given in the paper regarding the method for generating the dose or whether it would have comprised vapour or aerosol. - Statistical analysis was done, the paper does not report this in detail. We have to presume that appropriate and suitably powered methodology was used. - This paper is in a relevant and peer reviewed journal (5 months elapsed between being submitted and published)
J. Enrique Cometto-Muñiz, William S. Cain (1998). Trigeminal and olfactory sensitivity: comparison of modalities and methods of measurement. Int Arch Occup Environ Health (1998) 71: 105-110 - Primary aim of the study was to investigate sensitivity to nasal irritation by psychophysical methods (common detection procedure vs nasal lateralisation) - Study group comprised 5 anosmics (no sense of smell) and 4 normosmic (normal sense of smell) - 1-propanol, 1-butanol, 1-hexanol and 1-octanol investigated, concentrations were 100% and subsequent 3-fold dilutions (100%, 33.3%, 11.1% and 3.7%) - Again this study was not intended or powered to identify a “safe” concentration of any of the substances. In view of the non-standard test design, subjective assessment of results, and lack of relationship between the reported effects and evidence of harmfulness, these results cannot be considered to be key data. The above summary is included for completeness only.
References:
Kaestner, W. 1977. Zur Speziesabhangigkeit der Hautvertraglichkeit von Kosmetikgrundstoffen. J. Soc. Cos. Chem. 28:741-754.
Motoyoshi, K; et al. 1979 Comparative studies on the irritancy of oils
and synthetic perfumes to the skin of rabbit, guinea pig, rat, miniature
swine and man. Cosmetics and Toiletries 94: 41-48.
Justification for classification or non-classification
Based on the available information, dodecan-1-ol does not require classification for skin irritation; it requires classification for eye irritation, Category 2, H319: "Causes serious eye irritation" according to Regulation (EC) No 1272/2008.
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