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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
Irritation parameter:
other: score according to system defined
Basis:
other: rabbits
Time point:
24 h
Score:
5
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not given
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not given
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not given
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not given
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Individual scores not given
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.