Registration Dossier
Registration Dossier
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EC number: 219-775-3 | CAS number: 2528-61-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Heptanoyl chloride
- EC Number:
- 219-775-3
- EC Name:
- Heptanoyl chloride
- Cas Number:
- 2528-61-2
- Molecular formula:
- C7H13ClO
- IUPAC Name:
- heptanoyl chloride
- Details on test material:
- Name of the test substance used in the study report: n-Heptansaeurechlorid
Degree of purity/content: 98.6 g/100 g (GC)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young adult animals were used. They were identified via ear tattoo. The animals were housed in fully air-conditioned rooms with a central air-conditioning of 20-24°C for temperature and a relative humidty of 30 - 70%. The day/night rhthym was 12 hours dark and 12 hours light. The animals were housed singly.
The animals were offered a standardized laboratory diet (about 130 g per animal and day) as well as drinking water (250 ml per animal and day).
The acclimatization period was 1 week.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: fur was removed by clipping the dorsal part of the trunk
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 3 min and 1 hour
- Observation period:
- 8 days (1 animal), 15 days (2 animals)
- Number of animals:
- 3
- Details on study design:
- The test patch (2.5 x 2.5 cm) was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1). The test patch was moistened with a dose of 0.5 ml of the unchanged liquid test substance.
Application site: upper third of the back or flank.
Additional investigation: Because the visual assessment of the skin did not allow a statement with respect to the depth of necrotic changes (full-lthickness necrosis), a cross incision of the treated skin has been performed after the animal was killed at study termination. Additionally histopathological examination was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: 3-min application
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: 3-min application
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: 1-hour application
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: 1-hour application
- Other effects:
- Pathological-anatomical evaluation:
Skin - left flank - exposure period 1 h: severe necrosis. Skin - right flank - exposure period 3 min: slight scaling.
Histopathological examination:
Skin - left flank - 1-h exposure: focal full-thickness necrosis and moderate, deep infiltration of non-purulent inflammatory cells.
Skin - right flank - 3-3min exposure: slight superficial infiltration of non-purulent inflammatory cells.
Any other information on results incl. tables
Exposure |
Period |
3 min |
|
Reading |
Animal |
Erythema |
Edema |
1h |
1 |
3 |
2 |
|
2 |
2 |
0 |
|
3 |
2 |
0 |
24 h |
1 |
3 |
3 |
|
2 |
3 |
2 |
|
3 |
3 |
2 |
48 h |
1 |
3 |
2 |
|
2 |
3 |
2 |
|
3 |
3 |
2 |
72 h |
1 |
3 |
2 |
|
2 |
3 |
2 |
|
3 |
3 |
1 |
8 d |
1 |
2 |
1 |
|
2 |
1 |
0 |
|
3 |
2 |
1 |
15 d |
1 |
2 |
1 |
|
3 |
2 |
1 |
Mean |
1 |
3.0 |
2.3 |
|
2 |
3.0 |
2.0 |
|
3 |
3.0 |
1.7 |
Mean |
|
3.0 |
2.0 |
Exposure |
Period |
1 h |
|
Reading |
Animal |
Erythema |
Edema |
1h |
1 |
2 |
2 |
|
2 |
2 |
2 |
|
3 |
2 |
2 |
24 h |
1 |
3 |
2 |
|
2 |
3 |
2 |
|
3 |
3 |
2 |
48 h |
1 |
3 |
2 |
|
2 |
3 |
2 |
|
3 |
3 |
3 |
72 h |
1 |
3 |
2 |
|
2 |
3 |
2 |
|
3 |
3 |
2 |
8 d |
1 |
3 |
2 |
|
2 |
- |
2 |
|
3 |
3 |
2 |
15 d |
1 |
2 |
2 |
|
3 |
2 |
2 |
Mean |
1 |
3.0 |
2.0 |
|
2 |
3.0 |
2.0 |
|
3 |
3.0 |
2.7 |
Mean |
|
3.0 |
2.2 |
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions chosen and considering the described findings, the test substance gives indication of causing full thickness destruction of skin tissue as a result of an exposure period of 1 hour. After an exposure period of 3 minutes, the skin findings were not reversible within 8 or 15 days.
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