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Registration Dossier
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EC number: 947-787-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Done in conjunction with the LLNA method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source/batch No.of test material:
Sigma-Aldrich, Munich, Germany / Aldrich No. L1376
- Purity: 99% - Species:
- guinea pig
- Strain:
- other: SPF-Hsd Poc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
Harlan Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
SPF
- Weight at study initiation:
300 - 500 grams
- Housing:
Terluran cages on Altromin saw fiber bedding or Lignocel bedding
- Diet (e.g. ad libitum):
Ad libitum
- Water (e.g. ad libitum):
Ad libitum
- Acclimation period:
At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- other: 1:1 (v/v) mixture of FCA/physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 7 / 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 20 / 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 28 / 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 test animals and 5 control animals
- Details on study design:
- RANGE FINDING TESTS: Performed in a preliminary experiment assessing the irritant effects of the test compound after intradermal and topical application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 and Day 7 (48 hours)
- Test groups: One test group exposed to linoleic acid
- Control group: One control group exposed to vehicle only
- Frequency of applications: Once
- Duration: Day 0 to Day 20
- Concentrations: Intradermal induction - 5%; Topical induction - 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 20 and 28
- Exposure period: 24 hours
- Test groups: One test group exposed to linoleic acid
- Control group: One control group exposed to vehicle only
- Concentrations: 50%
- Evaluation (hr after challenge): 24, 48 and 72 hours
- Challenge controls:
- Vehicle only
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- Remarks on result:
- other: Not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- Remarks on result:
- other: Not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: Data inconclusive
- Conclusions:
- Due to non-specific irritative skin reactions observed, it was concluded that the challenge test concentration was too high, and no conclusion in regard to skin sensitization could be made.
- Executive summary:
Female SPF-Hsd Poc: DH guinea pigs, weighing between 300 and 500 grams, were obtained for this guinea pig maximisation test (GPMT). The guinea pigs were divided into 2 groups, a negative control group containing 5 guinea pigs, and a test group containing 10 guinea pigs. The animals recieved two induction treatments, an intradermal injection (day 0) and a topical application (day 7). The test concentrations used for the two induction tests were 5% linoleic acid for the intradermal induction and 100% linoleic acid for the topical induction. The animals also recieved two topical challenge treatments, one on day 20 and one on day 28. The test concentration used for the two challenge tests was 50% linoleic acid. Isotonic saline was used as the vehicle for the intradermal injection and vaseline was used as the vehicle for the topical exposures, and control animals were dosed with the vehicle alone. After challenge and re-challenge with linoleic acid, skin reactions were observed in the control group as frequently or even at a higher incidence than the test group. Therefore, it was concluded that the test concentration was too high and included irritative reactions and therefore no conclusion regarding skin sensitization could be drawn.
After challenge and re-challenge with linoleic acid, skin reactions were observed in the control group as frequently or even at a higher incidence than the test group. Therefore, it was concluded that the test concentration was too high and included irritative reactions and no conclusion regarding skin sensitization could be drawn.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Done in conjunction with the LLNA method
Test material
- Reference substance name:
- Linoleic acid
- EC Number:
- 200-470-9
- EC Name:
- Linoleic acid
- Cas Number:
- 60-33-3
- Molecular formula:
- C18H32O2
- IUPAC Name:
- octadeca-9,12-dienoic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source/batch No.of test material:
Sigma-Aldrich, Munich, Germany / Aldrich No. L1376
- Purity: 99%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF-Hsd Poc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
Harlan Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
SPF
- Weight at study initiation:
300 - 500 grams
- Housing:
Terluran cages on Altromin saw fiber bedding or Lignocel bedding
- Diet (e.g. ad libitum):
Ad libitum
- Water (e.g. ad libitum):
Ad libitum
- Acclimation period:
At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 1:1 (v/v) mixture of FCA/physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 7 / 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 20 / 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 28 / 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 test animals and 5 control animals
- Details on study design:
- RANGE FINDING TESTS: Performed in a preliminary experiment assessing the irritant effects of the test compound after intradermal and topical application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 and Day 7 (48 hours)
- Test groups: One test group exposed to linoleic acid
- Control group: One control group exposed to vehicle only
- Frequency of applications: Once
- Duration: Day 0 to Day 20
- Concentrations: Intradermal induction - 5%; Topical induction - 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 20 and 28
- Exposure period: 24 hours
- Test groups: One test group exposed to linoleic acid
- Control group: One control group exposed to vehicle only
- Concentrations: 50%
- Evaluation (hr after challenge): 24, 48 and 72 hours
- Challenge controls:
- Vehicle only
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- Remarks on result:
- other: Not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- Remarks on result:
- other: Not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
After challenge and re-challenge with linoleic acid, skin reactions were observed in the control group as frequently or even at a higher incidence than the test group. Therefore, it was concluded that the test concentration was too high and included irritative reactions and no conclusion regarding skin sensitization could be drawn.
Applicant's summary and conclusion
- Interpretation of results:
- other: Data inconclusive
- Conclusions:
- Due to non-specific irritative skin reactions observed, it was concluded that the challenge test concentration was too high, and no conclusion in regard to skin sensitization could be made.
- Executive summary:
Female SPF-Hsd Poc: DH guinea pigs, weighing between 300 and 500 grams, were obtained for this guinea pig maximisation test (GPMT). The guinea pigs were divided into 2 groups, a negative control group containing 5 guinea pigs, and a test group containing 10 guinea pigs. The animals recieved two induction treatments, an intradermal injection (day 0) and a topical application (day 7). The test concentrations used for the two induction tests were 5% linoleic acid for the intradermal induction and 100% linoleic acid for the topical induction. The animals also recieved two topical challenge treatments, one on day 20 and one on day 28. The test concentration used for the two challenge tests was 50% linoleic acid. Isotonic saline was used as the vehicle for the intradermal injection and vaseline was used as the vehicle for the topical exposures, and control animals were dosed with the vehicle alone. After challenge and re-challenge with linoleic acid, skin reactions were observed in the control group as frequently or even at a higher incidence than the test group. Therefore, it was concluded that the test concentration was too high and included irritative reactions and therefore no conclusion regarding skin sensitization could be drawn.
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