Registration Dossier
Registration Dossier
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EC number: 212-142-2 | CAS number: 765-30-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 26,1988-December 2,1988
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vivo study already available
Test material
- Reference substance name:
- Cyclopropylamine
- EC Number:
- 212-142-2
- EC Name:
- Cyclopropylamine
- Cas Number:
- 765-30-0
- Molecular formula:
- C3H7N
- IUPAC Name:
- cyclopropanamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Label:CYCLOPROPYLAMINE FL 881854 2.98 KG
- Received from:CIBA-GEIGY Corporation Agricultural Division P.O. Box 18300 Greensboro,North
Carolina 27419-8300
- Date reveived:October 6,1988
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:Room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
10.0% v/v in the ethanol for three treatments and 1.0% v/v in the ethanol for seven treatments and the challenge treatment
SOURCE OF TEST MATERIAL
- Label:CYCLOPROPYLAMINE FL 881854 2.98 KG
- Received from:CIBA-GEIGY Corporation Agricultural Division P.O. Box 18300 Greensboro,North
Carolina 27419-8300
- Date reveived:October 6,1988
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hrtley-Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley. Inc ., Houston. Texas
- Age at study initiation: young adult
- Weight at study initiation: 340-450 g
- Housing:five per cage
- Diet (e.g. ad libitum): Purina Guinea Pi gChow; available ad libitum
- Water (e.g. ad libitum):Tap; available ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Day(s)/duration:
- 56 days
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: Day 0,Day 3,Day 6
- Exposure period:Day 0-Day 7
- Site:on the left front quadrant
- Concentrations:
test group:10% v/v solution of the test material in ethanol
control group:0.05% v/v solution of 2,4-dinitrochlorobenzene in ethanol
B. CHALLENGE EXPOSURE
- No. of exposures: 7
- Day(s) of challenge: Day 8,Day 10,Day 13,Day 15,Day 17,Day 20,Day 22
- Exposure period: Day 8 - Day 35
- Site:on the left rear quadrant
- Concentrations:
test group:1% v/v solution of the test material in ethanol
control group:0.05% v/v solution of 2,4-dinitrochlorobenzene in ethanol
- Evaluation (hr after challenge): Observations for skin reactions were made approximately 24 hours after each treatment for each test site. In addition, observations for skin reactions were made approximately 48 hours after treatment 1 and 10 and the challenge treatment on Day 36.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2.4-dinitrobenzzene
Results and discussion
- Positive control results:
- A sensitizing reaction was produced by the positive control substance.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% v/v solution of 2,4-dinitrochlorobenzene in ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05% v/v solution of 2,4-dinitrochlorobenzene in ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0% v/v solution of the test material in ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0% v/v solution of the test material in ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Executive summary:
In a dermal sensitization study with Cyclopropylamine in ethanol, young adult Hartley-Albino guniea pig (10 animals per group/male) were tested using the method of Guinea pig maximisation test. A 0.05% v/v solution of 2,4-dinitrochlorobenzene in ethanol was ustilizedas positive control material.
A sensitizing reaction was produed by the 1.0% v/v solution of Cyclopropylamine in ethanol. In this study, cyclopropylamine is a dermal sensitizer classified as Category 1 based on the test result.
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