Registration Dossier
Registration Dossier
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EC number: 927-895-9 | CAS number: 1168150-46-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 January - 04 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD ) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- DEVIATIONS:
Structure-activity relationship for irritancy was determined retrospectively (instead of determination prior to the in vivo study).
Deviations from the specified range for relative humidity (45 – 75 %) were observed intermittently: for short periods of time during cleaning in the morning, relative humidity
rose up to approximately 95 %. - GLP compliance:
- yes
Test material
- Reference substance name:
- CD 352 XX
- IUPAC Name:
- CD 352 XX
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CD 352 XX
- Physical state: yellow crystals
- Analytical purity: 99.9 % (HPLC)
- Purity test date: 12 january 2006
- Lot/batch No.: V12CRE00175
- Expiration date of the lot/batch: guaranteed until november 2006
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG
- Age at study initiation: approximately 6 - 12 months
- Weight at study initiation: 3.6 – 4.6 kg (day of application)
- Housing: individually in solid wire cages
- Diet (e.g. ad libitum): Dry food (Kliba No. 3413.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland), ad libitum
- Water (e.g. ad libitum): municipal drinking water were supplied ad libitum
- Acclimation period: 5- to 6-day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2°C
- Humidity (%): 45-75 %
- Air changes (per hr): approximately 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 h, with lights on from 6:00 h to 18:00 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- ca. 500 mg per animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 h, 24 h, 48 h, 72 h after exposure
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm², dorsal skin of the rabbit
- Type of wrap if used: muslin tissue, non-skin-irritating plaster
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
STRUCTURE ACTIVITY RELATIONSHIP
No alerts for dermal irritative or corrosive activity of the test item were obtained by the DEREK program
IN VITRO ASSAY
Using the MTT in vitro assay, an EC(50) for the cytotoxic effect in NIH 3T3 murine fibroblasts was determined at 19.74 μg/mL medium.
CD 352 XX had no irritating or corrosive effect on rabbit skin subsequent to dermal application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, CD 352 XX was well tolerated subsequent to topical application on rabbit
skin. There were no macroscopic signs of irritation or corrosion. In addition, there were no
signs of systemic side effects or of skin alterations beyond the area of exposure.
Thus, according to the GHS, the test item CD 352 XX is not classified.
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