Hexan-1-ol

Endpoint summary

Description of key information

In the in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, hexan-1-ol was concluded to be mildly irritating, but not sufficient to trigger classification (Jacobs and Martens, 1987). A group mean 24+48+72-hour erythema score of >2 (2.13) was reported. Although individual scores were not reported, 6 animals were used and it is considered that hexan-1-ol is a mild irritant according to GHS criteria, but the effects observed were insufficient for classification according to Regulation (EC) No 1272/2008. In addition, data from tests in human suggest rabbit to be a more sensitive species with no irritant effects present in human (Kaestner 1978; rel 2).

In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, hexan-1-ol was concluded to be irritating to eyes (ECETOC, 1998). Hexan-1-ol is classified for eye irritation Category 2A according to GHS criteria and Category 2 according to Regulation (EC) No 1272/2008 based on individual mean 24+48+72-hour scores in at least 2 test animals of => 1 for corneal opacity and iritis and => 2 in at least 2 test animals for conjunctival chemosis and redness. Only 1 animal scored => 3 for corneal opacity or => 1.5 for iritis.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

Examination time points: 1, 24, 48 and 72 hours after end of application

Number of animals:

6

Details on study design:

- Area of exposure: 6 cm2
- Occlusion: Under and exposure chamber
- Scoring system: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.13

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: 72 hour score 2.2

Remarks:

Individual animal scores were not presented

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.6

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Remarks:

Individual animal scores were not presented

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: (individual scores were not reported

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: (individual scores were not reported

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: (individual scores were not reported

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: (individual scores were not reported

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: (individual scores were not reported

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: (individual scores were not reported

Other effects:

Erythema and oedema were observed at 1 hour post-exposure.

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Remarks:

Not classified according to Regulation (EC) No 1272/2008.

Conclusions:

In the in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, hexan-1-ol was concluded to be mildy irritating, but not sufficient to trigger classification. A group mean 24+48+72-hour erythema score of >2 (2.13) was reported. Although individual scores were not reported, 6 animals were used and it is considered that hexan-1-ol is a mild irritant according to GHS criteria, but the effects observed were insufficient for classification according to Regulation (EC) No 1272/2008.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

exposure period was 24 hours

GLP compliance:

no

Species:

other: rabbit, guineapig, hairless mouse, human volunteers

Type of coverage:

occlusive

Vehicle:

other: vaseline

Amount / concentration applied:

Concentration: 50 %

Duration of treatment / exposure:

24 hour(s)

Number of animals:

4

Details on study design:

In this comparative study C6-C22 fatty alchols were applied to the skin of rabbits, guineapigs, hairless mice and human volunteers in a 24-hour occluded exposure. All applications were made at a concentration of 50% in vaseline. The test sites were scored on a 5 class system as follows: Class 1 (0-1 points) practically no skin irritation
Class 2 (2-5) causes marginal reactions in some animals of the group, which fade away rapidly Class 3 (6-10) causes marginal or slight reactions, which fade away  rapidly
Class 4 (11-20) causes clear reactions Class 5 (>20) causes strong reactions The results were represented in a bar chart comparing the reaction classes between species for each alcohol.

Irritation parameter:

other: score according to system defined

Basis:

other: result for human, rabbit and hairless mice

Time point:

24 h

Score:

1

Max. score:

5

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

individual animal scores were not presented

Irritation parameter:

other: score according to system defined

Basis:

other: result for guinea pig

Time point:

24 h

Score:

2

Max. score:

5

Reversibility:

fully reversible

Remarks on result:

other: marginal reactions in some animals of the group, which fade away rapidly

Remarks:

individual animal scores were not presented

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: individual data were not given

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: individual data were not given

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: individual data were not given

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: individual data were not given

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: individual data were not given

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: individual data were not given

Irritant / corrosive response data:

The most marked skin reactions were observed with rabbits, the degree of  irritancy was related to carbon chain length. Minimal reactions were 
observed with the lower and higher chain alcohols with irritancy increasing from class 3 at C8, class 4 (C10 & 12) to a maximum class 5 at C14, 
then reducing to class 3 at C16 & 18. The human scores generally were less than those of the rabbits and reached a peak of class 3 with the C10 
alcohol. A similar pattern of response though much less marked (all scores classified as <=2) was observed with hairless mouse skin. The 
response in guinea pigs followed no obvious pattern and all scores were classed as <=3. In some cases alcohols have been given descriptive ratings for rabbits and man in Iuclid datasets. These ratings together with the actual gradings 
from this reference are reported below. 
1-hexanol: rabbit and man reaction class 1 (Kaestner 1977).
1-octanol: rabbit and man moderately irritating (Iuclid 2000 1-octanol)  reaction class 3 for rabbits and 2 for man (Kaestner 1977).
1-decanol: rabbit reaction class 4, man class 3 (Kaestner 1977).
1-dodecanol: reaction class 4 for rabbits and 2 for man (Kaestner 1977).
Tetradecanol: rabbit highly irritating, man not irritating (Iuclid 2000  tetradecanol), rabbit reaction grade 5, man 1 (Kaestner 1977)
Hexadecanol: rabbit reaction grade 3, man 1 (Kaestner 1977)
Octadecanol: rabbit reaction grade 3, man 1 (Kaestner 1977) C20 and C22 alcohols: reaction grade 2 for rabbits and 1 for man.

Interpretation of results:

GHS criteria not met

Conclusions:

This comparative skin irritation study shows that the rabbit is the most sensitive test species. There is a relationship between carbon chain length with maximum response at C14 producing persistent strong skin reactions after a 24-hour occlusive exposure. Decanol and dodecanol produced clear skin reactions which did not regress rapidly. All other skin reactions (including those of human volunteers) were at most slight and rapidly reversible. Hexan-1-ol applied as 50% in vaseline produced practically no skin irritation in rabbits, hairless mice and human volunteers and marginal irritation in guineapigs.

Cited in Iuclid 2000.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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:

None included in report.

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml

- Concentration (if solution): 100%, undiluted

Duration of treatment / exposure:

The eye was not rinsed of the test substance, the first observations were made at 1h and 4h.

Observation period (in vivo):

1,h, 4h, 24, 48, 72 hours, 7, 10, 14 and 21 days (assessments made until the test eye for each animal showed complete reversal to 
normal up to 21 days).

Number of animals or in vitro replicates:

4, sex unspecified

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed


SCORING SYSTEM: Grading Scale for Eye Irritation Effects, OECD, 1987. Grading Scale and Multiplication Factors, Draize et al. 1944.


TOOL USED TO ASSESS SCORE: no data

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The study was included as part of a data base of in vivo eye irritation results. All studies were conducted to OECD guideline 405 under GLP.

AVERAGE SCORE (24+48+72 hour)
- Cornea: Individual 3, 2, 2, 1.7 Mean 2.2
- Iris: Individual 2, 1, 1, 1.3 Mean 1.3
- Conjunctivae (Redness): Individual 3, 2, 3, 2.7 Mean 2.7
- Conjunctivae (Chemosis): Individual 3, 2, 3, 2 Mean 2.5
- Overall irritation score: MMAS (modified maximum score 64.8)

REVERSIBILITY: Effects on the cornea and iris had reversed by 7 days, redness and/or chemosis persisted to 7 days in one rabbits, 10 days in 2 

animals and 14 days in the final rabbit, all scores were 0 by day 21.

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Category 2 according to Regulation (EC) No 1272/2008.

Conclusions:

IIn the in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, hexan-1-ol was concluded to be irritating to eyes. Hexan-1-ol is classified for eye irritation Category 2A according to GHS criteria and Category 2 according to Regulation (EC) No 1272/2008 based on individual mean 24+48+72-hour scores in at least 2 test animals of => 1 for corneal opacity and iritis and => 2 in at least 2 test animals for conjunctival chemosis and redness. Only 1 animal scored => 3 for corneal opacity or => 1.5 for iritis.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, hexan-1-ol was concluded to be mildly irritating, but not sufficient to trigger classification (Jacobs and Martens, 1987).  In the study the undiluted hexan-1-ol was applied onto the skin of 6 rabbits for 4 hours under occlusive dressing. Erythema and oedema skin reactions were evaluated at 1, 24, 48 and 72 hours after the end of the application. Erythema and oedema were observed at 1-hour post-exposure. A group mean 24+48+72-hour erythema score of >2 (2.13) was reported. Although individual scores were not reported, 6 animals were used and it is considered that hexan-1-ol is a mild irritant according to GHS criteria, but the effects observed were insufficient for classification according to Regulation (EC) No 1272/2008.

The conclusion from the Jacobs and Martens (1987) study is supported by a reliability 2 supporting study (Scientific Associates Inc., 1977) with mean scores of >2 in both intact and abraded skin, although information beyond 72 hours post-exposure observation period is lacking. A comparative study by Kaestner (1977; rel 2) reports the test material to be slightly irritating in guinea pig, but not in rabbit, hairless mice or human. It also suggests that hexan-1-ol is not irritating to skin. A comparative 24-hour semi-occluded human skin patch study by Kaestner (1977; rel 2) reported only slight, readily reversible irritation in humans. It should be noted that the results from Kaestner’s comparative study suggests the percutaneous irritative effects of hexan-1-ol to be more pronounced in rabbits than man.

In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, hexan-1-ol was concluded to be irritating to eyes (ECETOC, 1998). In the study, 0.1 ml of undiluted hexan-1-ol was instilled into the eyes of 2 rabbits. The eyes were not rinsed following instillation. Eye irritation reactions were made at 1 hour, 4, 24, 48, 72 hours and on day 7, 10, 14 and 21 post-instillation. Effects were seen on the cornea, iris and conjunctiva. Effects on the cornea and iris were fully reversible by day 7, redness and/or chemosis were still evident on day 7 in one rabbit, day 10 in 2 

rabbits and day 14 in the final rabbit, all scores were 0 by day 21. Hexan-1-ol was concluded to be classified for eye irritation Category 2A according to GHS criteria and Category 2 according to Regulation (EC) No 1272/2008 based on individual mean 24+48+72-hour scores in at least 2 test animals of => 1 for corneal opacity and iritis and => 2 in at least 2 test animals for conjunctival chemosis and redness. Only 1 animal scored => 3 for corneal opacity or => 1.5 for iritis.

A supporting study (Jacobs&Martens 1987) does not provide individual scores, but reports a group mean score of >2 for conjunctival redness, and the description of the lesions in the second supporting study (Scientific Associates 1977), further support that hexan-1-ol is irritating to the 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; Motoyoshiet 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; tetradecanol 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 hexan-1-ol (derived in the AGW paper) is 210 mg/m3. The value for hexan-1-ol (derived in the AGW paper) is 210 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.

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, hexan-1-ol does not require classification for skin irritation; classification for eye irritation Category 2, H319: "Causes serious eye irritation" is required according to Regulation (EC) No 1272/2008.