Registration Dossier
Registration Dossier
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EC number: 246-309-6 | CAS number: 24549-06-2
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: guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-ethyl-2-toluidine
- EC Number:
- 246-309-6
- EC Name:
- 6-ethyl-2-toluidine
- Cas Number:
- 24549-06-2
- Molecular formula:
- C9H13N1
- IUPAC Name:
- 2-ethyl-6-methylaniline
- Details on test material:
- purity: 99.75%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand White albino rabbit
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Housing: single in steel mesh cage (typ III-hoch)
- Diet: standard diet "ssniff K 4"
- Water: ad libitum
- Acclimation period: at least 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10fold per hour
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: none
- Controls:
- not required
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1 h, 24 h, 48 h, 72 h, 7 d
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Fixomull-Strech Klebevlies, Beiersdorf No. 2039
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritant / corrosive response data:
- no effects
Any other information on results incl. tables
RS-Freetext:
no signs of irritation appeared within 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
In a guideline study (OECD 404) with New Zealand White albino rabbits, no irritation/corrosion response was found after
2 -ethyl-6 -methylaniline treatment (Bayer 1989).
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