Registration Dossier
Registration Dossier
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EC number: 425-120-4 | CAS number: 83847-14-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Feb 1997 - 07 Mar 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT Assay was conducted before the LLNA Assay became mandatory.
Test material
- Reference substance name:
- -
- EC Number:
- 425-120-4
- EC Name:
- -
- Cas Number:
- 83847-14-7
- Molecular formula:
- C23H23NO5
- IUPAC Name:
- 4-cyanophenyl 4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoate
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Kisslegg
- Age at study initiation: about 4 weeks
- Weight at study initiation: 364 to 421 g
- Housing: Two guinea-pigs were housed in a Makrolon cage type IV (floor area: 55 x 33 cm = 1815 cm2 , height: 20 cm) with a shelter, placed on mobile racks
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: healthy guinea-pigs were used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 51 - 76
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1 g/L
- Day(s)/duration:
- On Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5 g/L
- Day(s)/duration:
- On Day 8/ 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 g/L
- Day(s)/duration:
- On Day 22/ 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals (test group)
10 animals (control group) - Details on study design:
- RANGE FINDING TESTS:
To determine the concentrations suitable for the main study, a pretest with single intradermal or topical administrations of the vehicle and of the test item preparations was performed. Intradermal injections were given to one animal. Topical applications were given to another three animals, two with and one without FCA injection.
Based on the results of the preliminary study, the following concentrations were chosen:
Intradermal induction: 1.0 g/L in liquid paraffin (slightly irritant)
Topical induction: 5.0 g/L in liquid paraffin (slightly irritant)
Topical challenge: 0.1 g/L in liquid paraffin (not irritant)
MAIN STUDY
A.1 INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: six (three on each side of the spinal column)
- Test groups: FCA + phys. sodium chloride solution, Test material 1.0 g/L in liquid paraffin, FCA with test + phys. sodium chloride solution (1.0 g/L completed preparation)
- Control group: FCA + phys. sodium chloride solution, liquid paraffin, FCA + phys. sodium chloride solution
- Site: shoulder region (cranial, medial, caudal)
- Frequency of applications: once
- Concentrations: 1.0 g/L test material
A.2 INDUCTION EXPOSURE (topical application, occlusive)
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 5.0 g/L test item in liquid paraffin
- Control group: liquid paraffin (undiluted)
- Site: shoulder region
- Frequency of applications: once
- Concentrations: 5.0 g/L test material
B. CHALLENGE EXPOSURE
- No. of exposures: Once
- Day(s) of challenge: On day 22
- Exposure period: 24 hours
- Test groups: 0.1 g/L test material in liquid paraffin; liquid paraffin only
- Control group: 0.1 g/L test material in liquid paraffin; liquid paraffin only
- Site: flank
- Concentrations: 0.1 g/L test material
- Evaluation (hr after challenge): 48 and 72 hours
- Challenge controls:
- The control group was challenged with liquid paraffin only or 0.1 g/L of the test material in liquid paraffin
- Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Positive reactions 48 hours after challenge with HCA: 6/20 animals
Positive reactions 72 hours after challenge with HCA: 6/20 animals
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 g/L
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.1 g/L
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.1 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5 g/L
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 5 g/L
- No. with + reactions:
- 6
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is to be considered as skin sensitizer based on the results obtained from the GPMT Assay according to OECD Guideline 406.
- Executive summary:
The test item was studied for skin sensitizing properties in the guinea-pig maximization test according to OECD Guideline 406. Ten female guinea-pigs in the negative control group (group 1) and 20 females in the test material group (group 2) were investigated.
Induction included intradermal injection of test material preparation (1 g/L with and without Freund's complete adjuvant) on day 1, and topical application of test material preparation ( 5 g/L) on day 8.
Challenge by topical application with the test material preparation ( 0.1 g/L) was performed two weeks a:fter topical induction. Positive reactions (erythemas) were observed in 12 of 20 animals (60 per cent) overall. Based on the results, the test item has to be considered as skin sensitizer.
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