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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
3 Aug - 5 Aug 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles (analytical purity of test substance not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
A single epicutaneous application (occlusive) is done on the back of at least 12 human volunteers to assess the skin irritation potential of the substance. Readings and scoring are peformed 30 min and 24 hours after patch removal.
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Ester of Isononanoic acid with Isononanol
- Physical state: colorless oil
- Analytical purity: not specified

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 12
- Sex: 5 males and 7 females
- Age: 21-64
Ethical approval:
confirmed, but no further information available
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
estimated
Details on exposure:
About 0.02 mL of the product (saturating a disc of filter paper placed in the patch) was applied once, on about 50 mm² of skin on the upper back of each volunteer and kept in contact with the skin for 24 h.
- two control cups are always applied: 1) 1% of sodium lauryl sulfate; 2) distilled water
Examinations:
SCORING SYSTEM FOR SKIN REACTIONS:
Erythema (Redness)
0 None
1 Doubtful pinkness of all the site or clearly visible pinkness of any part of the site
2 Clear pinkness of all the site or redness of only a part of the site
3 Clear redness of all the site or intensive redness of part of the site
4 Intensive redness and/or burn aspect
Edema
0 None
1 Doubtful swelling of all the site or slight swelling of only part of the site
2 Slight swelling of all the site or clear swelling of only a part of the site
3 Clear swelling of all the site or strong swelling of only a part of the site
4 Strong swelling of all the site, even extending beyond the site
Vesicles
0 None
1 Few small vesicles (< 1mm diameter), on less than ¼ of the site
2 Small vesicles (< 1mm diameter), on about ¼ of the site
3 Small vesicles (< 1mm diameter), on ¼ to ½ of the site
4 Some small vesicles (< 1 mm diameter), on more than half of the site, or some large vesicles ( 1 to 2 mm diameter)
Cutaneous Dryness
0 None
1 Dullness, matness of all the site or powdery aspect of only a part of the site
2 Powdery aspect of all the site or some scaling/flaking of only a part of the site
3 Scaling/flaking of all the site or thick scales/flakes on only a part of the site
4 Some thick scales/flakes on all the site with possibly deep cracking
Wrinkling
0 None
1 Slight wrinkling of all the site or clear wrinkling of only a part of the site
2 Distinct wrinkling of all the site or well-developed wrinkling of only a part of the site
3 Well-developed wrinkling into ridges anf throughs of all the site or severe wrinkling of only a part of the site
4 Wrinkling forms deep throughs and high ridges
Glazing
0 None
1 All site slightly shiny or only part of the site clearly shiny
2 All site clearly shiny or glossiness of only a part of the site
3 Clear glossiness of all the site or very glossy aspect of only a part of the site
4 All site very glossy and/or highly reflective

Results and discussion

Clinical signs:
Negative control site: no reactions for all volunteers; Positive control site: slight to clear reactions on 11 sites, no reaction on one subject; Test product site: no reactions observed on 10 subjects, very slight erythema for 2 subjects. The one subject which did not show skin reactions for the positive control was excluded from the study.
Results of examinations:
The irritation index was calculated from the 11 subjects who were retained. The scores attributed allowed to obtain an irritation index of 0.02.

Applicant's summary and conclusion

Conclusions:
Not irritating.

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