Hexan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

review article or handbook

Title:

Zur Speziesabhängigkeit der Hautverträglichkeit von Kosmetikgrundstoffen

Author:

Kaestner W

Year:

1977

Bibliographic source:

J. Soc. Cos. Chem. 28:741-754

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

exposure period was 4 hours

Principles of method if other than guideline:

Method: other

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecanol

EC Number:

204-000-3

EC Name:

Tetradecanol

Cas Number:

112-72-1

Molecular formula:

C14H30O

IUPAC Name:

tetradecan-1-ol

Test animals

Species:

other: human

Details on test animals or test system and environmental conditions:

In addition to human volunteers, the aliphatic alcohols were also tested in rabbit, guineapig and hairless mouse.

Test system

Type of coverage:

semiocclusive

Vehicle:

other: vaseline

Amount / concentration applied:

Concentration: 50 %

Duration of treatment / exposure:

24 hour(s)

Number of animals:

4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: score according to system defined

Basis:

other: human

Time point:

other: 24 hours

Score:

1

Reversibility:

fully reversible

Remarks on result:

other: marginal or slight reaction, which faded away rapidly

Results 2

Irritation parameter:

other: score according to system defined

Basis:

other: rabbits

Time point:

24 h

Score:

5

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: Individual scores not given

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: Individual scores not given

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: Individual scores not given

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: Individual scores not given

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: Individual scores not given

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: Individual scores not given

Any other information on results incl. tables

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. In all cases the human scores  were less those of the rabbits and reached a peak of class 3 with the C10  

aclohol. A similar pattern of response though much less marked (all  scores classified as <=2) was observed with hairless mouse skin. The  

response in guineapigs followed no obvious pattern and all scores were  classed as <=3.

The results for C8, C12, C14, C16 and C18 alcohols have been given  descriptive ratings for rabbits and man in various Iuclid datasets on  

aliphatic alcohols and these ratings (where available) 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.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

This comparative skin irritation study shows that the rabbit is the most sensitive test species, but that results in rabbits do not accurately predict resuts in humans. There is a relationship between carbon chain length with maximum response at C14 producing persistent strong skin reactions after a 24 hour semi-occlusive exposure. Decanol and dodecanol produced clear skin reactions in rabbits which did not regress rapidly. All other skin reactions (including those of human volunteers) were at most slight and rapidly reversible. The data presented indicate that tetradecan-1-ol is not irritating to humans

Executive summary:

This comparative skin irritation study shows that the rabbit is the most sensitive test species, but that results in rabbits do not accurately predict resuts in humans. There is a relationship between carbon chain length with maximum response at C14 producing persistent strong skin reactions after a 24 hour semi-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.