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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Skin irritation and corrosion: refenrence chemicals data bank.
Author:
ECETOC
Year:
1995
Bibliographic source:
Technical report no.66, ECETOC
Report date:
1995

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanal
EC Number:
203-898-4
EC Name:
Heptanal
Cas Number:
111-71-7
Molecular formula:
C7H14O
IUPAC Name:
heptanal
Details on test material:
Purity = 95.0%

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
Concentration = 100%
Volume tested = 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
4
Details on study design:
no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
4 rabbits
Time point:
other: 24-48-72
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 3 animals have a mean score higher to 2, but 1 animal have a mean score higher to 2.3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
4 rabbits
Time point:
other: 24/48/72
Score:
5
Max. score:
10.7
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.16
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

Table : Skin irritation data for individual rabbits

Observation interval

1 hour

1 day

2 days

3 days

7 days

Animal no.1

Erythema

1.5

3.5

3.5

3.5

3.5

Oedema

0.5

2

2

2

2

Animal no.2

Erythema

1.5

3.5

3.5

3.5

3.5

Oedema

1.5

2.5

2

1.5

1.5

Animal no.3

Erythema

1

2

3

3

3

Oedema

1

3

2.5

2.5

2

Animal no.4

Erythema

1

2

2

2.5

2.5

Oedema

0.5

1.5

1.5

1.5

2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Conclusions:
According this study, heptanal is a skin irritant in rabbits, and is classified in category 2 according to the Regulation (EC) no.1272/2008 (CLP).
Executive summary:

Heptanal was tested on four rabbit at a concentration of 100% during 4 hours. The observation interval was 7 days.

The mean score of erythema was 3 out of 4 (mean of 4 rabbits, and mean of results at 24/48/72 hours).

The mean score of edema was 2 out of 4 (mean of 4 rabbits, and mean of results at 24/48/72 hours).

The effects were not fully reversible at 7 days. A desquamation from the skin was observed in all four rabbits at 7 days.

According this study, heptanal is a skin irritant in rabbits, and is classified in category 2 according to the Regulation (EC) no.1272/2008 (CLP).

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