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Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
From 14th of July to 18th of August, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted according to acceptable scientific conditions according to good clinical practice; number of volunteers, applied dose, observation time and observed parameters are acceptable. Substance identification: informations available from industrial for commercial name (C14-C17 normal Paraffins) Substance analytical certificate not available
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The method is that summarized by Phillips et al. (Toxicology and Applied Pharmacology 21:369-382, 1972). The fresh materials are applied 5 days weekly for 21 days to the same site. Patches are not reapplied on week ends (or holidays); they remain in place for these periods. There are 15 days of reading, even when holidays intervene.
All individuals received all test concentrations.
The chambers were separated by more than 2 cm, depending on the height of the volunteer.
The delayed challenge is week 6. The delayed challenge utilized what is deemed a non-irritating concentration of Norpar 15, utilizing the same patch. If positives are identified on challenge, the operational definition of allergic contact dermatitis (reteest, serial dilutions and Provocative Use Test (PUT) will be performed to ascertain if irritation of allergic in nature. The patch is an occlusive plastic chamber held in place with paper tape.
Readings are made at each removal of the patch on a 0-4 scale.
Any site which reaches a level of 2 (according to predefined scoring scale: erythema + edema) is discontinued.
GLP compliance:
no
Remarks:
Study conducted according to principals of GCP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NORPAR 15
-Substance type: petroleum product, UVCB
- Analytical substance: 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: 26 started the study, 22 finished the study
- 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:
Negative controls were:
- Vaseline intensive Care Lotion at test site #5
- Mineral oil at test site #6 (solvent control)
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: 5% Norpar 15 in Mineral oil
Site #2: 10% Norpar 15 in Mineral oil
Site #3: 25% Norpar 15 in Mineral oil
Site #4: 75% Norpar 15 in Mineral oil
Site #5: Vaseline intensive Care Lotion
Site #6: Mineral Oil
Delayed challenge phase:
non-irritating concentration of Norpar 15

- Volume applied: no data
- Testing/scoring schedule:
°fresh material is applied 5 days weekly for 21 days.
°15 days of reading
° delayed challenge is performed on week 6.
- 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= bullae

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed:
During induction phase:
no subject developed reaction on test sites 1, 2, 3, and 6.
4 subjects developed reaction on test site 4: 2 sujects showed a mean score of 1.5, 1 subject showed a mean score of 6, 1 subject showed a mean score of 27.
3 subject developed a reaction on site 5. one subject had equivocal reaction, one subject showed a mean score of 6, one subject showed a mean score of 8, one subject showed a mean score of 8.5, one suject showed a mean score of 10.

During challenging phase:
No subject developed reaction on test site 1, 2, 3, 5, and 6.
1 subject developed a reaction on test site 4, with a mean value of 2. On retest, this was negative

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 16
- Number of subjects with equivocal reactions:1
- Number of subjects with irritating reactions: 6

Applicant's summary and conclusion

Conclusions:
75% NORPAR 15 was a cumulative irritant but this was negative on retest. NORPAR 15 did not induce allergic contact dermatitis.
Executive summary:

The sensitization potential of NORPAR 15 was assessed in a study conducted on 25 volunteers. Three subjects cancelled before the end of the study. The substance was diluted in mineral oil at 5%, 10%, 25%, 75% and applied under an occlusive patch chamber on site 1 to 4. Vaseline intensive Care Lotion was used as negative control (site 5) and Mineral oil as solvent control (site 6). The test substance was applied 5 days weekly for 21 days to the same site. There are 15 days of reading. All subjects received all test substance concentrations and both control substances.

The delayed challenge is conducted at week 6. The used delayed challenge used was deemed as non-irritating concentration of Norpar 15. Readings are made at each patch removal site using a scale from score 0 to 4.

During the 21-day induction phase, no subject developed reaction on test sites 1, 2, 3, and 6. Four subjects developed reaction on 75% concentration test site (site 4), two subjects showed a mean score of 1.5, one subject showed a mean score of 6 and one subject showed a mean score of 2.7.

Six subjects developed a reaction at true negative control site (site 5): one subject had equivocal reaction (mean score 0.5) while the other subjects showed a mean score from 1 to 10.

During challenging phase, no subject developped reaction on test site 1, 2, 3, 5, and 6 and only one subject developed a reaction (mean score 2) at 75% test substance site 4. On retest, this was negative.

Under the occlusive patch test conditions, 75% NORPAR 15 was a cumulative irritant. However, NORPAR 15 did not induce allergic contact dermatitis.