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EC number: 248-131-4 | CAS number: 26952-14-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-07-01 to 1981-08-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because although the study does not meet current OECD 406 guidelines, the study was well conducted and reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1981-07-01 to 1981-08-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because although the study does not meet current OECD 406 guidelines, the study was well conducted and reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- According to OECD 406 guidelines, the initiating dose should be the highest dose to induce mild irritation.
- GLP compliance:
- yes
- Type of study:
- patch test
- Justification for non-LLNA method:
- The study was conducted in accordance with OECD and EU test guidelines applicable at the time of undertaking.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Laboratories, Wayne, New Jersey
- Age at study initiation: Not reported
- Weight at study initiation: Approximately 400 to 450 grams
- Housing: Five animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 to 22.2
- Humidity (%): 39% to 55%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: 1981-06-30 To: 1981-09-21 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- 1% Neodene 6 in ethanol
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- 1% Neodene 6 in ethanol
- No. of animals per dose:
- 5 animals/sex/dose
- Details on study design:
- RANGE FINDING TESTS: Yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Three weeks
- Test groups: One test group receiving 1.0% initiating dose
- Control group: A vehicle and positive control were used
- Site: Back/trunk region
- Frequency of applications: Once a week
- Duration: Six hours
- Concentrations: 1.0%
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: One
- Exposure period: Six hours
- Test groups: Test site and a virgin site
- Control group: A vehicle and positive control were used
- Site: Back/trunk region immediate posterior to the original site
- Concentrations: 1.0%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Challenge controls were treated the same as test animals except some received a vehicle instead of test compound and some received nothing until the challenge dose.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
- Statistics:
- None were reported
- Positive control results:
- The positive control group had an average skin reaction of 0.53 in the first week, but an average skin reaction of 1.34 after the challenge exposure indicating a positive skin reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Neodene 6 alpha olefin was not a skin sensitizer under the conditions of this study.
- Executive summary:
In a dermal sensitisation study using Neodene 6 alpha olefin in ethanol, Duncan Hartley guinea pigs (5 animals/sex/dose) were tested using a patch sensitisation method. For the three weekly initiating doses, a 1% solution Neodene 6 alpha olefin in ethanol was applied and the primary challenge dose was also 1% Neodene 6 alpha olefin in ethanol. Preliminary tests indicate that the 1% concentration was appropriate for the challenge dose, but a dose causing mild irritation should have been chosen for the initiating dose. Reactions were scored with a numerical grade to indicate severity. The positive control provided the appropriate response. Body weight gain was not affected by treatment. Neodene 6 alpha olefin caused little or no irritation after the initiation or challenge dose and did not induce a delayed contact hypersensitivity reaction under the conditions of the study.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because although the study does not meet current OECD 406 guidelines, the study was well conducted and reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- According to OECD 406 guidelines, the initiating dose should be the highest dose to induce mild irritation.
- GLP compliance:
- yes
- Type of study:
- patch test
- Justification for non-LLNA method:
- The study was conducted in accordance with OECD and EU test guidelines applicable at the time of undertaking.
Test material
- Reference substance name:
- Hex-1-ene
- EC Number:
- 209-753-1
- EC Name:
- Hex-1-ene
- Cas Number:
- 592-41-6
- Molecular formula:
- C6H12
- IUPAC Name:
- hex-1-ene
- Details on test material:
- - Name of test material (as cited in study report): NEODENE-6 alpha olefin
- Substance type: C6 aliphatic
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: Not reported, assigned sample number 571A
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Laboratories, Wayne, New Jersey
- Age at study initiation: Not reported
- Weight at study initiation: Approximately 400 to 450 grams
- Housing: Five animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 to 22.2
- Humidity (%): 39% to 55%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: 1981-06-30 To: 1981-09-21
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- 1% Neodene 6 in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- 1% Neodene 6 in ethanol
- No. of animals per dose:
- 5 animals/sex/dose
- Details on study design:
- RANGE FINDING TESTS: Yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Three weeks
- Test groups: One test group receiving 1.0% initiating dose
- Control group: A vehicle and positive control were used
- Site: Back/trunk region
- Frequency of applications: Once a week
- Duration: Six hours
- Concentrations: 1.0%
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: One
- Exposure period: Six hours
- Test groups: Test site and a virgin site
- Control group: A vehicle and positive control were used
- Site: Back/trunk region immediate posterior to the original site
- Concentrations: 1.0%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Challenge controls were treated the same as test animals except some received a vehicle instead of test compound and some received nothing until the challenge dose.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Study design: in vivo (LLNA)
- Statistics:
- None were reported
Results and discussion
- Positive control results:
- The positive control group had an average skin reaction of 0.53 in the first week, but an average skin reaction of 1.34 after the challenge exposure indicating a positive skin reaction.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Neodene 6 alpha olefin was not a skin sensitizer under the conditions of this study.
- Executive summary:
In a dermal sensitisation study using Neodene 6 alpha olefin in ethanol, Duncan Hartley guinea pigs (5 animals/sex/dose) were tested using a patch sensitisation method. For the three weekly initiating doses, a 1% solution Neodene 6 alpha olefin in ethanol was applied and the primary challenge dose was also 1% Neodene 6 alpha olefin in ethanol. Preliminary tests indicate that the 1% concentration was appropriate for the challenge dose, but a dose causing mild irritation should have been chosen for the initiating dose. Reactions were scored with a numerical grade to indicate severity. The positive control provided the appropriate response. Body weight gain was not affected by treatment. Neodene 6 alpha olefin caused little or no irritation after the initiation or challenge dose and did not induce a delayed contact hypersensitivity reaction under the conditions of the study.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because although the study does not meet current OECD 406 guidelines, the study was well conducted and reported.
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