Registration Dossier
Registration Dossier
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EC number: 909-125-3 | CAS number: -
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:
- other: Well conducted and documented study. In accordance with GLP and current guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decanamide, N,N-dimethyl-, mixt. with N,N-dimethyloctanamide
- Cas Number:
- 67359-57-3
- IUPAC Name:
- Decanamide, N,N-dimethyl-, mixt. with N,N-dimethyloctanamide
- Details on test material:
- - Name of test material (as cited in study report): Hoe S 4166
- Substance type:
- Physical state: yellow liquid
- Composition of test material, percentage of components: see confidential details on test material
- Boiling point: circa 250°C
- Density: circa 0.88 kg/l
- Solubility: insoluble in water
- Lot/batch No.:E O 6212107 dated 04. June 1992
- Expiration date of the lot/batch: till June 1994
- Stability under test conditions:
- Storage condition of test material: in the dark at roomtemperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF-Zucht, Chemisch pharmazeutische Fabrik Dr. Karl Thomae GmbH / 88400 Biberach / Germany
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.0-3.2kg
- Housing: single cages in air-conditioned rooms
- Diet (e.g. ad libitum): Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionized, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12h each
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml undiluted substance - Duration of treatment / exposure:
- 4h
- Observation period:
- 0.5h, 24h, 48h and 72h as well as 7d, 14d and 21d after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5*2.5 cm
- Type of wrap if used: bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure the test substance is removed using handwarm tap water
- Time after start of exposure:4h
SCORING SYSTEM:Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: average of 24h, 48h and 72h reading
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: average of 24h, 48h and 72h reading
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21d
- Irritant / corrosive response data:
- 0.5-1h after removing the patch all animal showed moderate to severe erythema and slight to severe edema. Average reading values (24h, 48h and 72h reading, mean from all animals) are:
erythema 3.3 and edema 3.0. Full reversibility was observed after 21 days, whereas a moderate erythema was could be observed at day 7 reading and slight erythema and edema were observed 14 day after exposure.
No signs of corrosion were reported.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- irritant
- Executive summary:
To assess the irritant potential of Hoe S 4166 a skin irritation test according to EG-Guideline B.4. Akute Toxizität Hautreizung der Richtlinie 84/449/EWG fullfilling also the OECD guideline 404 was conducted. Therefore 3 New Zealand White rabbits were exposed to the test substance for 4h. After washing gradings were scored after 0.5h, 24h, 48h, 72h, 7d, 14d and 21d.
0.5-1h after removing the patch all animal showed moderate to severe erythema and slight to severe edema. Average reading values (24h, 48h and 72h reading, mean from all animals) are:
erythema 3.3 and edema 3.0. Full reversibility was observed after 21 days, whereas a moderate erythema was could be observed at day 7 reading and slight erythema and edema were observed 14 day after exposure.
No signs of corrosion were reported.
Based on this result the substance has to be labelled as irritating to skin according to EU GHS EC 1272/2008.
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