Registration Dossier
Registration Dossier
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EC number: 268-130-2 | CAS number: 68003-46-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-10-25 to 2004-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium N-methyl-N-(1-oxododecyl)glycinate
- EC Number:
- 268-130-2
- EC Name:
- Ammonium N-methyl-N-(1-oxododecyl)glycinate
- Cas Number:
- 68003-46-3
- Molecular formula:
- C15H29NO3.H3N
- IUPAC Name:
- ammonium 2-(N-methyldodecanamido)acetate
- Test material form:
- other: liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 4166310
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Test animals
- Species:
- rabbit
- Strain:
- other: Albino rabbits (Chbb:HM)
- Details on test animals or test system and environmental conditions:
- TEST animals:
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight of study initiation: 2500 - 2600 g
- Housing: the rabbits (females) were caged individually in polyphenyl ether (PPE) cages with perforated floor.
- Diet: pelleted complete diet Altromin 2123 (Altromin GmbH, Lage, Germany), ad libitum
- Water: (tap/filtered) water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark/hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated site of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h - Observation period:
- Initial test: 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Confirmatory test: 14 days
Reading time points: 1, 24, 48 and 72 h and 7 and 14 days - Number of animals:
- initial test: 1 female
confirmatory test: 2 females - Details on study design:
- TEST SIDE:
- Area of exposure: 6,25 cm² on the right side of the back
- Type of wrap: The treated skin was covered with adhesive Gothaplast tape (2,5 cm)
REMOVAL OF TEST SUBSTANCE:
- Washing: Residual test material was removed with mild soap and lukewarm water.
- Time after start of exposure: initial test: 3 min, 1 and 4 h: confirmatory test: 4 h
SCORING SYSTEM:
Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- - Animal #1 showed a well-defined erythema on the posterior right test field immediately after the application.
- 1 h after termination of exposure a well-defined erythema was observed on the posterior right test field of animal #1. Animal #2 and #3 showed a very slight erythema on the anterior left test fields.
-24 h, 48 h and 72 h after the termination of exposure a well-defined erythema was observed on the posterior right test field of animal #1. Animals #2 and #3 showed a well-defined erythema on the anterior left test field.
- 7 days after the termination of the exposure isolated scales were still observed on the anterior left test field of animal #2 and #3. Animal #1 showed no skin reactions.
- 14 days after the termination of exposure animals #2 and #3 were free of any signs of skin irritation, too.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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