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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:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restriction, reporting of results limited.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1-Undecanol

- Substance type: Undecyl alcohol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data available.

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
other: undiluted (also as 25 and 50% solution in PEG 400)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Concentration (if solution): Test material was applied as three different doses; undiluted and 25% and 50% in polyethylene glycol MW 400.


VEHICLE : glycol MW 400
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours (Examination points at 1, 24, 48 and 72 hours)
Number of animals:
6
Details on study design:
TEST SITE

- coverage: 6cm2


REMOVAL OF TEST SUBSTANCE

-not reported

SCORING SYSTEM: Draize scoring criteria.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
> 2
Max. score:
3
Remarks on result:
other: Compound preparation: neat. Irritating to skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
> 2
Max. score:
2.8
Remarks on result:
other: Compound preparation: 50% undecanol in polyethylene glycol MW 400. Irritating to skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
> 1
Max. score:
2
Remarks on result:
other: Compound preparation: 25% undecanol in polyethylene glycol MW 400. Not irritating.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.8
Max. score:
0.8
Remarks on result:
other: Compound preparation: neat.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
> 0.5
Max. score:
0.8
Remarks on result:
other: Compound preparation: 50% undecanol in polyethylene glycol MW 400.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Remarks on result:
other: Compound preparation: 25% undecanol in polyethylene glycol MW 400.
Irritant / corrosive response data:
Individual animal scores were not reported.
Other effects:
REVERSIBILITY: Irritation scores were only reported up to 72 hours after exposure and over this time course the irritant effects were not reversible. 
Group mean erythema scores increased over this observation period for all test concentrations. For undiluted material erythema scores were as 
follows 24 hour 1.5; 48 hours 2.4; 72 hour 3, oedema remained constant at 0.8. Erythema scores with the 50% solution increased from 2.2 to 2.8 
while the oedema score reduced from 0.8 to 0.2. The 25% solution showed an increase in erythema score from 1.2 to 2.0 there was no oedema. 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Following a 4 hour occlusive exposure to rabbit skin undiluted undecanol was found to be irritant according to both EU and GHS (category 2) criteria. 25 and 50% dilutions in PEG400 were also tested, the 50% dilution was irritant under EU criteria while both the 25% and 50% dilutions would be considered mild irritants (category 3) under GHS.

Classification: irritating