Registration Dossier
Registration Dossier
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EC number: 605-315-2 | CAS number: 163149-28-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1994-08-01 to 1995-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because the study was reportedly conducted according to generally accepted GLP standards and appeared to closely follow OECD 406 guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Dec-1-ene, dimers, hydrogenated
- EC Number:
- 500-228-5
- EC Name:
- Dec-1-ene, dimers, hydrogenated
- Cas Number:
- 68649-11-6
- IUPAC Name:
- 68649-11-6
- Details on test material:
- - Name of test material (as cited in study report): ORONITE SYNFLUID PAO 2 cST (C1234-50-3)
- Substance type: Poly alpha olefin (1-decene dimer hydrogenated)
- Physical state: Clear colourless liquid
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, P.O. Box 29176, Indianapolis, Indiana 46229
- Age at study initiation: Young adult
- Weight at study initiation: 446 to 487 grams; naive controls weighed 319 to 443 grams
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): Teklad Guinea pig diet; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not provided
- Humidity (%): Not provided
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12 hours dark.12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Spectrum Oil
- Concentration / amount:
- 5 % W/V in spectrum oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Spectrum Oil
- Concentration / amount:
- 5 % W/V in spectrum oil
- No. of animals per dose:
- 20 test animal, 10 naive control, and 2 groups of 4 animals for the pilot study
- Details on study design:
- RANGE FINDING TESTS:
50, 25, 10, 5, 2.5, 1, and 0.5% W/V in spectrum oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours each
- Test groups: 20 animals, 10 males/10 females
- Control group: 10 naive control, 5 males/ 5 females
- Site: Left shoulder for the test group; backs for the pilot group
- Frequency of applications: Once a week
- Duration: 3 weeks
- Concentrations: Not specified
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Not specified
- Exposure period: 6 hours
- Test groups: 20, 10 males/10 females
- Control group: 10, 5 males/ 5 females
- Site: Skin site not previously exposed in the pilot and induction phase
- Concentrations: 5 % W/V in spectrum oil
- Evaluation (hr after challenge): 24 and 48 hours post exposure
- Challenge controls:
- Ten naive animals served as challenge controls.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% W/V in spectrum oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% W/V in spectrum oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % W/V in spectrum oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % W/V in spectrum oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 % W/ V in spectrum oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 % W/ V in spectrum oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 % W/V in spectrum oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 % W/V in spectrum oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Any other information on results incl. tables
The primary challenge, at 5% dilution, resulted in a grade 1 response, which was of less incidence and severity than the naïve control group. Based on these results, it was determined that sensitization to the test material was not induced.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- ORONITE SYNFLUID PAO 2 cST (C1234-50-3) is not a skin sensitizer to Hartley Guinea pigs.
- Executive summary:
In a delayed contact hypersensitivity study, male and female Hartely guinea pigs were treated with ORONITE SYNFLUID PAO 2 cST (C1234-50-3) in a pilot study followed by an induction study with an exposure of 6 hours per treatment for three weeks. Following a 2 week rest period, the test animals and a naïve control group were challenged with 5 % test chemical W/V in spectrum oil. The animals were scored for skin sensitising reactions at 24 and 48 hours following the challenge phase.
The primary challenge resulted in a grade 1 response, which was of less incidence and severity than the naïve control group. Based on these results, it was determined that sensitization to the test material was not induced.
This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because the study was reportedly conducted according to generally accepted GLP standards and appeared to closely follow OECD 406 guidelines. This study will influence the DNEL(s).
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