Registration Dossier
Registration Dossier
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EC number: 936-023-6 | CAS number: 950782-86-2
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:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine
- EC Number:
- 619-749-5
- Cas Number:
- 730979-19-8
- Molecular formula:
- C16H20FN5
- IUPAC Name:
- N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: young adults
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in cage units Metall Noryl by EBECO; excrement trays below the cages contained low dust wood granulate bedding.
- Diet (e.g. ad libitum): standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): tap water ad libitum from polycarbonate bottles
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, moistened with water to ensure good contact with the skin. - Duration of treatment / exposure:
- 3 min, 1 hour, 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: rigt and left side of the dorso-lateral area of the trunk of each rabbit were shorn on the day before the test
- Type of wrap if used: moistened substance was applied to the skin under a gauze patch (treated area approx. 2.5x2.5 cm in size). The patch was held in place with non-irritating tape for the duration of the exposure period
REMOVAL OF TEST SUBSTANCE
- Washing: yes, carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 3 min, 1 hour, 4 hours
SCORING SYSTEM: Draize, the surrounding untreated skin served as control.
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:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- After 3 min and 1 hour exposure time no effects were observed. After exposure for 4 hours very slight erythema (barely perceptible) was observed in one animal which completely reversed until the 48-hour reading. The other animals did not show any effects.
- Other effects:
- No signs of systemic toxicity were observed.
Any other information on results incl. tables
According to the criteria of Directtive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.
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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