Registration Dossier
Registration Dossier
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EC number: 203-149-1 | CAS number: 103-83-3
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: OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
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:
- Benzyldimethylamine
- EC Number:
- 203-149-1
- EC Name:
- Benzyldimethylamine
- Cas Number:
- 103-83-3
- Molecular formula:
- C9H13N
- IUPAC Name:
- benzyldimethylamine
- Details on test material:
- purity: 99.34 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.6-2.8 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposit site
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24 hours
- Number of animals:
- 3 (2 males and 1 female
- Details on study design:
- according to OECD TG 404, Scoring according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 5.2
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks on result:
- other: 24 hours post application the treatment aerea showed erythema, severe reddened to black, crusts, edema, slight to severe indurations. Therefore the observation period was terminated and the rabbits were killed due to ethical reason.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- 24 hours post application the treatment aerea showed erythema, severe reddened to black, crusts, edema, slight to severe indurations. Therefore the observation period was terminated and the rabbits were killed due to ethical reason.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- 24 hours post application the treatment aerea showed erythema, severe reddened to black, crusts, edema, slight to severe indurations. Therefore the observation period was terminated and the rabbits were killed due to ethical reason.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- s terminated and the rabbits were killed due to ethical reason.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- s terminated and the rabbits were killed due to ethical reason.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- s terminated and the rabbits were killed due to ethical reason.
- Irritation parameter:
- edema score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- s terminated and the rabbits were killed due to ethical reason.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Executive summary:
N,N-dimethylbenzylamine was applied to the skin of rabbits to evaluate the irritant potency the test as performed according to OECD TG 404 and resulted in severe erythema score 4 of (max) 4 including black areas, crusts, edema, slight to severe indurations. According to these severe skin reactions observed (deep red to black injuries) the animals were kept only for an observation period of 24 hours they were killed due to ethical reason after this period (BG Chemie 1987)
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