Registration Dossier
Registration Dossier
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EC number: 605-659-3 | CAS number: 173046-61-2
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
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)
- EC Number:
- 605-659-3
- Cas Number:
- 173046-61-2
- Molecular formula:
- Mixture of C6H11O3-[C3H6O]p-[C2H4O]q-[C3H3O]r-C7H14ON and C6H11O3-[C3H6O]p-[C2H4O]q-[C3H3O]s
With: 0
- IUPAC Name:
- Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)
- Test material form:
- liquid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1/92
- Physical State/appearance: liquid, slight yellowish
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.55 -2.90 kg
- Housing: single housing
- Diet (e.g. ad libitum):about 130 g per animal per day; Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): about 250 ml tap wter per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern and Fixomull Stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/Water (1:1)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1h, 24 h, 48 h, 72 h and 8 d
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1h
Any other information on results incl. tables
Readings |
Animal |
Erythema |
Edema |
1 h |
1 |
1 |
0 |
2 |
1 |
0 |
|
3 |
0 |
0 |
|
24 h |
1 |
1 |
0 |
2 |
1 |
0 |
|
3 |
0 |
0 |
|
48 h |
1 |
2 |
0 |
2 |
1 |
0 |
|
3 |
1 |
0 |
|
72 h |
1 |
2 |
0 |
2 |
1 |
0 |
|
3 |
1 |
0 |
|
8 d |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
Mean |
1 |
1.7 |
0.0 |
2 |
1.0 |
0.0 |
|
3 |
0.7 |
0.0 |
|
Mean |
|
1.1 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions chosen and considering the described findings Laromer LR 8889 X does not give indication of an irritant property to the skin.
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