Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Type of study / information:
The skin irritation potential following repeated exposure to test material was determined in a 21-day human cumulative irritation patch test in 23 volunteers under controlled testing conditions.
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
The skin irritation potential following repeated exposure to test material was determined in a 21-day human cumulative irritation patch test in 23 volunteers under controlled testing conditions. The 21-day continuous closed patch test or cumulative irritation test in humans offers the greatest discrimination among chemicals regarding their potential irritant effect on human skin. The scientific literature indicates that this well-established assay is most ueful in evaluating low grade irritants and compounds which have frequent/repeated and intimate exposure to human skin.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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
Molecular formula:
C20H42
IUPAC Name:
Hydrogenated dimerization products of 1-decene
Constituent 2
Reference substance name:
1-decene dimer, hydrogenated
IUPAC Name:
1-decene dimer, hydrogenated
Details on test material:
- Name of test material (as cited in study report): SHF21

Method

Ethical approval:
not specified
Details on study design:
Test material was occlusively applied to the back, between the scapulae and waist, adjacent to the spinal mid-line, using a 4 square centimeter pad of non-woven cotton covered with test material on nonporous plastic tape. Twenty-one consecutive applications of the test material were allowed to contact the skin for 23.5 hours. Approximately 0.5 hour was allowed as a minimum rest period between patch removal and scoring. Sites were scored between each reapplication and after the final application for a total of 21 evaluations per site.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Test material was occlusively applied to the back, between the scapulae and waist, adjacent to the spinal mid-line, using a 4 square centimeter pad of non-woven cotton covered with test material on nonporous plastic tape. Twenty-one consecutive applications of the test material were allowed to contact the skin for 23.5 hours. Approximately 0.5 hour was allowed as a minimum rest period between patch removal and scoring. Sites were scored between each reapplication and after the final application for a total of 21 evaluations per site.

TYPE OF EXPOSURE MEASUREMENT: cumulative irritative index 0-630

EXPOSURE LEVELS: neat material reapplied 1/d


EXPOSURE PERIOD: 21 days


The positive control sample (0.1% w/v sodium lauryl sulfate in water) and a negative control sample (petroleum jelly).

Results and discussion

Results:
No untoward effects were observed with any of the subjects entered into this study. Based on the findings, the test material was judged to be a “probably mild” material in normal use with evidence of a slight potential for mild cumulative irritation.

Any other information on results incl. tables

Each site was graded for skin irritation using a scale from 0 (no response visible) to 5 (intense vesibular/bullous eruption). Accordingly, there were 21 daily scores for each of the 23 individuals tested. Slight dermal irritation was observed with average scores of 1 (mild response, slight erythema and/or dryness and/or few tiny denudations or other mild responses) being achieved within 5 days of test initiation. The highest average score, approximately 1.2, was achieved on day 7, and, from that point on, scores of 1 or less were reported, i.e., although some irritation was observed, the condition stabilized and did not progressively worsen. The maximum scores recorded were approximately 2 (moderate erythema and/or small denudations or other moderate responses). The authors judged this result to be a demonstration of "negligible irritation under an occlusive patch". The positive control used in this test (0.1% sodium lauryl sulfate in water) produced average scores of 3, and the negative control, petrolatum, was not irritating.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test, the test material was judged to demonstrate mild irritation.
Executive summary:

The potential for skin irritation following acute and repeated exposure for 1-decene dimer, hydrogenated, was assessed in humans via a 21-day cumulative irritation study in human volunteers (Keyline Research, 1992). To do this, 1-decene dimer, hydrogenated was applied daily (0.2 ml under occlusive patch) for 21 consecutive days. Each patch was held in contact with the skin for 23.5 hours, then removed. Each site was given a dermal irritation score, and then fresh test material was applied. Each site was graded for skin irritation using a scale from 0 (no response visible) to 5 (intense vesibular/bullous eruption). Accordingly, there were 21 daily scores for each of the 23 individuals tested. Slight dermal irritation was observed with average scores of 1 (mild response, slight erythema and/or dryness and/or few tiny denudations or other mild responses) being achieved within 5 days of test initiation. The highest average score, approximately 1.2, was achieved on day 7, and, from that point on, scores of 1 or less were reported, i.e., although some irritation was observed, the condition stabilized and did not progressively worsen. The maximum scores recorded were approximately 2 (moderate erythema and/or small denudations or other moderate responses). The authors judged this result to be a demonstration of "negligible irritation under an occlusive patch". The positive control used in this test (0.1% sodium lauryl sulfate in water) produced average scores of 3, and the negative control, petrolatum, was not irritating.