Registration Dossier
Registration Dossier
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EC number: 810-816-6 | CAS number: 1473386-36-5
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- heptadecyl (branched) acrylate
- EC Number:
- 810-816-6
- Cas Number:
- 1473386-36-5
- Molecular formula:
- C20H38O2
- IUPAC Name:
- heptadecyl (branched) acrylate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Age at study initiation: Approx. 6 - 8 months
- Weight at study initiation: 3.40 - 4.01 kg
- Housing: single housing
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: al least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: untreated skin sites same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (2.5 cm x 2.5 cm) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1)
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Readings |
Animal No. |
Erythema |
Edema |
Additional Findings |
0h |
1 |
2 |
0 |
Erythema beyond the application area
|
2 |
2 |
0 |
- |
|
1h |
1 |
2 |
1 |
Erythema and edema beyond the application area
|
2 |
2 |
0 |
- |
|
24h |
1 |
3 |
3 |
Erythema and edema beyond the application area
|
2 |
2 |
1 |
Erythema beyond the application area
|
|
48h |
1 |
4 |
3 |
Erythema and edema beyond the application area
|
2 |
3 |
1 |
Erythema beyond the application area
|
|
72h |
1 |
3 |
2 |
Erythema and edema beyond the application area
|
2 |
3 |
2 |
Erythema and edema beyond the application area
|
|
7d |
1 |
3 |
2 |
Erythema and edema beyond the application area, severe scaling
|
2 |
2 |
1 |
Severe scaling, Scaling,erythema and edema beyond the application are
|
|
14d |
1 |
3 |
1 |
Erythema and edema beyond the application area, severe sacaling
|
2 |
1 |
0 |
Scaling |
|
Mean 24h – 72h |
1 |
3.3 |
2.7 |
|
2 |
2.7 |
1.3 |
|
|
Mean |
- |
|
|
|
The cutaneous reactions were not reversible in both animals within 14 days after removal of the patch. On study day 14, moderate erythema (grade 3) and very slight edema (grade 1) beyond the application site and scaling was noted while the other animal showed very slight erythema (grade1) and scaling at study termination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Considering the not fully reversible cutaneous reactions within the observation period as well as the average score for irritation, Heptadecyl Acrylate (C17A) shows a skin irritating potential under the test conditions chosen.
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