Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Contribution à l'étude toxicologique de l'alcool n-heptylique primaire
Author:
R.Truhaut
Year:
1974
Bibliographic source:
Archives des maladies Professionnelles de Médecine du Travail. 35, No 4-5, Avril-Mai
Report Date:
1974

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity>97%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of non diluted sample
Duration of treatment / exposure:
4 hours
Observation period:
24 and 72 hours
Number of animals:
6 rabbits
Details on study design:
0.5 ml of heptanol was applied on 6 rabbits with intact skin and 6 rabbits with or abraded skin.
SCORING SYSTEM: according to the DRAIZE scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h+72h
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h+72 h
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h+72h
Score:
0.75
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h+72h
Score:
0.25
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified. Criteria used for interpretation of results: EU
Conclusions:
n-heptanol is considered as a slightly irritant.
Executive summary:

The acute dermal irritation of n-heptanol-1 was evaluated in rabbits according to OECD 404 guideline. n-heptanol-1 was applied undiluted to the skin of 6 New-Zealand White albino rabbits and held in contact for 4 hours by means of a semi-occlusive dressing. Mean scores over 24, and 72 hours were 0.75 and 0.25 for erythema and for edema, respectively. Under these experimental conditions, n-heptanol 1 was considered a slightly irritant when applied topically to rabbits.