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EC number: 221-111-2 | CAS number: 3006-86-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-04-10 to 1996-05-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted in 1992 when the LLNA was not an established testing method yet.
Test material
- Reference substance name:
- Cyclohexylidenebis[tert-butyl] peroxide
- EC Number:
- 221-111-2
- EC Name:
- Cyclohexylidenebis[tert-butyl] peroxide
- Cas Number:
- 3006-86-8
- Molecular formula:
- C14H28O4
- IUPAC Name:
- 1,1-bis(tert-butylperoxy)cyclohexane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., P.O. Box 29176; Indianapolis, Indiana 46229
- Age at study initiation: young adult
- Weight at study initiation: 373 to 681 g
- Housing: individually housed in wire mesh suspension cages
- Diet: teklad guinea pig diet; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Squibb mineral oil
- Concentration / amount:
- - Induction: 50 % of the test item; undiluted: vehicle control
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Squibb mineral oil
- Concentration / amount:
- - Challenge: 50 % of the test item; 50 % of the vehicle
- No. of animals per dose:
- 10 guinea pig per sex
- Details on study design:
- RANGE FINDING TESTS: The irritation potential of the test item at levels of 50 %, 25 %, 10 % and 5 %, was evaluted in a single group of four animals, such that each animal in a given pilot group was exposed to the same levels. In additional pilot, repeating the concentrations evaluated in pilot 1 plus four additional concentrations of 2.5 %, 1 %, and 0.5 % and undiluted Squibb mineral oil. All formulations were prepared w/v in Squibb mineral oil. The 50%, 25 %, 10 %, and 10 %, and 5 % formulation produced grades of +/-. The 2.5 %, 1 %, and 0.5 % formulations and the undiluted Squibb mineral oil produced grades of 1 and +/-.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: six-hour exposures (+/- 15 minutes)
- Test groups: 50 % of the test item
- Control group: undiluted vehicle
- Site: left shoulder
- Frequency of applications: thrice (once every seven days for fourteen days)
- Duration: six hour
- Concentrations: 50 %
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day of challenge: 28
- Exposure period: once
- Test groups: 50 % of the test item
- Control group: 50 % of the test item
- Site: left flank
- Concentrations: 50 %
- Evaluation (hr after challenge): 24, 48 hour - Challenge controls:
- no
- Positive control substance(s):
- yes
- Remarks:
- historical data
Results and discussion
- Positive control results:
- The animals were induced by 1 exposure with 0.3 % (ethanol) 1-chloro-2,4-dinitrobenzene. The animals were induced by 3 exposures at weekly intervals with 2.5 % (ethanol) alpha-hexylcinnamaldehyde.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- slight but confluent, or moderate patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- slight but confluent, or moderate patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight but confluent, or moderate patchy erythema
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following primary challenge using cyclohexylidenebis[tert-butyl]peroxide, as a 50 % w/v formulation in Squibb mineral oil, the incidence of grade 1 responses in the test group (9 of 20) was compared to that of the vehicle control group (4 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the vehicle control group indicating that sensitization had not been induced.
- Executive summary:
Cyclohexylidenebis[tert-butyl]peroxide was tested in the Buehler test with guinea pigs according to OECD guideline no. 406. A 50 % w/v concentration of the test item, in Squibb mineral oil was chosen for occlusive epidermal induction of the test group. This level was chosen as the highest concentration causing no greater than mild to moderate primary irritation. Undiluted Squibb mineral oil was utilized at induction for the vehicle control group. The procedure was repeated at the same site once every seven days for fourteen days for a total of three approximate six-hour exposures. A 50 % w/v concentration of cyclohexylidenebis[tert-butyl]peroxide, in Squibb mineral oil was chosen for epidermal application at primary challenge for the test group and the vehicle control group. This level was chosen as the highest concentration causing no more than slight primary irritation. Following primary challenge using cyclohexylidenebis[tert-butyl]peroxide, as a 50 % w/v formulation in Squibb mineral oil, the incidence of grade 1 responses in the test group (9 of 20) was compared to that of the vehicle control group (4 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the vehicle control group indicating that sensitization had not been induced.
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