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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 group
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 group
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).