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Registration Dossier
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EC number: 434-440-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 May - 6 June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximisation Test was performed prior to the amendment of Regulation (EC) No 1907/2006 in which the Local Lymph Node Assay is given as the first-choice in vivo study.
Test material
- Reference substance name:
- -
- EC Number:
- 434-440-3
- EC Name:
- -
- Cas Number:
- 86329-09-1
- Molecular formula:
- C8H15NSO
- IUPAC Name:
- O-(2-methylpropyl) prop-2-en-1-ylcarbamothioate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, UK
- Age at study initiation: approx. 4 - 7 weeks
- Weight at study initiation: 352 - 433 g
- Housing: 5 animals per cage in metal cages with wire mesh floors, hay was given thrice weekly
- Diet: vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -26
- Humidity (%): 37 -68
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 2.5%
- Day(s)/duration:
- single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 37.5% and 50%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (controls), 20 (test group)
- Details on study design:
- RANGE FINDING TESTS:
A range finding study was performed to determine the appropriate dose level of the test substance following intradermal and epicutaneous administrations. The intradermal and epicutaneous irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the epicutaneous route for the challenge phase. Animals were treated with an intradermal injection of 50% (v/v) FCA/water approximately 1 week prior to start of the range-finding study.
For the intradermal administration test substance concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10% were injected intradermally in two animals each. Test substance concentrations of up to and including 2.5% caused irritation but did not adversely affect the animals.
For the epicutaneous administration test substance concentrations of 25, 50, 75 and 100% were applied to shaved skin of four animals. No skin reactions were observed up to and including 75% test substance concentration tested 24 and 48 h after removal of the patch. Erythema (score 1) was observed in 2/4 animals at 100% test substance concentration 24 and 48 h after removal of the patch.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/water
Injection 2: test substance in Alembicol D
Injection 3: test substance in a 1:1 mixture (v/v) of FCA and Alembicol D
Epicutaneous: undiluted test substance
- Control group:
Injection 1: a 1:1 mixture FCA/water
Injection 2: Alembicol D
Injection 3: a 1:1 mixture (v/v) of FCA and Alembicol D
Epicutaneous: Alembicol D
- Site: dorsal skin on the scapular region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 2.5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left anterior flank (75%) and left posterior flank (37.5%)
- Concentrations: 37.5 and 75%
- Evaluation: 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde, induction: intradermal 10%, epicutaneous 100%, challenge: 50 and 100%
Results and discussion
- Positive control results:
- The positive control substance induced positive reactions (score 1 and 2) in 10/10 animals (100% first and second reading), thus meeting the reliability criteria for the Guinea Pig Maximisation Test (≥ 30% positive response). The positive control group was not carried out concurrently with this study but is a historical background data group from a study performed between 15 December 1997 and 8 January 1998.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 37.5 and 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 37.5%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 75%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 10%; challenge: 50 and 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 37.5 and 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 37.5%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 75%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 10%; challenge: 50 and 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
Any other information on results incl. tables
Intradermal induction:
Necrosis was recorded at sites receiving FCA in test and control animals. Slight to well-defined irriation (score 1 and 2) was seen in test animals at sites receiving either 2.5% (v/v) test substance in Alembicol D or Alembicol D alone.
Epicutaneous induction:
Slight to well-defined erythema (score 1 and 2) was observed in test animals following application with the undiluted test substance. Slight erythema (score 1) was seen in control animals.
Body weight:
Animals showed expected body weight gain during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens. 1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the guinea pig maximisation test the test substance revealed sensitising properties at an intradermal induction dose of 2.5% in > 30% of the animals.
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