Distillates (Fischer-Tropsch), 210-360 degree Celcius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 4th of December 1995 to 12th January, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Dermal irritation and sensitisation in human (Draize patch test in semi-occlusive conditions) Study conducted according to acceptable scientific conditions: high number of volunteers, single applied dose, observation time and observed parameters are acceptable. Substance identification: information available from industrial for commercial name (C14-C17 n-paraffins) No substance analytical certificate available in the report

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

The study is performed by modification of the procedure set forth by Draize. The test patches are moistened with approximately 0.2 mL of the test material and adequately secured to the skin by means of occlusive bandage. The patch is an occlusive plastic chamber held in place with paper tape. Patches of the test material are applied to the upper arms or backs of all panelists. The samples are applied to the patches shortly before application to the panelists' skin.
The study is performed in approximately a six-week period for each subject. During the first three weeks, or the induction period, patches are applied thrice weekly. Patches applied on friday are removed after 48 h, patches applied on fridays are removed after 72h. All applications of samples are made to the same site.
Approximately two weeks after the induction phase, a single challenge or elicitation application is made. The patch is applied to a previously unpatched site. The challenge patches are removed 72h following applications. Reactions to the challenge applications are scored at 96 h following applications.

GLP compliance:

no

Remarks:

study conducted according to principals of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Paraffin, normal, C5-C20

IUPAC Name:

Paraffin, normal, C5-C20

Details on test material:

- Name of test material (as cited in study report): NORPAR 15
- Substance type: petroleum product, UVCB
- Analytical purity: 100% Commercial product
- Composition of test material, percentage of components: C14-C17 normal paraffins

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 109 adults started the study, 105 finished
- Sex: no data
- Age: over 18
- Race: no data
- Demographic information: no data

Clinical history:

Prior to acceptance into the study, all subjects were examined and deemed to be free of any active skin pathology. Medical histories and consent forms were obtained from all subjects.

Controls:

100% mineral oil, applied on site 2.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive for both phases
- Description of patch: occlusive plastic chamber (Hilitop, Cincinnati, OH) held in place with paper tape (Scanpre, Norgepaster, Oslo)
- Vehicle / solvent: Mineral Oil (Lot #0923-2492-16)
- Concentrations:
Induction phase:
Site #1: 25% Norpar 15 in Mineral oil
Site #2: 100% Mineral oil

Delayed challenge phase:
non-irritating concentration of Norpar 15

- Volume applied: 0.2 mL
- Testing/scoring schedule:
°during the first three weeks, patches are applied 3 times a week
°15 days of reading
° delayed challenge is performed on week 6: a single challenge application is made.
- Removal of test substance:
- Other:

EXAMINATIONS
- Grading/Scoring system:
0= negative
+ = equivocal reaction (0.5)
1= erythema
2 = erythema and induration
2 = erythema, induration and vesicles
4= erythema, induration and bullae

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed:
There was no evidence of irritation, neither in theinduction phase nor in the elicitation of allergic contracts dermatitis with these test samples in any of the 105 subjects. There were no drops outs for toxicity related reasons.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 105
- Number of subjects with equivocal reactions:0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

No additional data.

Applicant's summary and conclusion

Conclusions:

Under the test conditions, NORPAR 15 did not induce allergic contact dermatitis.

Executive summary:

The study is performed by modification of the procedure set forth by Draize to determine NORPAR 15 sensitisation potential in 109 volunteers. Four subjects cancelled before the end of the study.

The test substance was diluted at 25% in mineral oil. The skin occlusive plastic chamber patches were moistened with approximately 0.2 mL of 25% dilution NORPAR 15 or mineral oil as solvent negative control and applied at different skin site. Patches are applied to the upper arms or backs of all panelists.

The study is performed in approximately a six-week period for each subject. During the first three weeks considered as the induction period, patches are applied thrice weekly. All applications of test substance were made to the same site. Approximately two weeks after the induction phase, a single challenge application was performed by test substance patch application to a previous unpatched site. The challenge patches were removed 72 h following applications. Reactions to the challenge applications are scored at 96 h following applications. No subject showed any skin reaction during the induction nor the challenging phase.

Under the occlusive patch test conditions, NORPAR 15 did not induce allergic contact dermatitis.