Registration Dossier
Registration Dossier
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EC number: 203-898-4 | CAS number: 111-71-7
Skin irritation / corrosion
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:
- 1 995
- 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
- 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%
Constituent 1
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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