Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed under recognised International Regulatory Guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
Principles of method if other than guideline:
OECD Guideline For The Testing of Chemicals (2009), Draft proposal for a new guideline: In Vitro Skin Irritation: Human Skin Model Test. Year 2009. EPISKIN three dimensional human skin model.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diisoamyl phthalate
- Physical state: colourless to slightly yellow clear liquid
- Analytical purity: 99.98%
- Purity test date: Not reported
- Lot/batch No.: 7920-1-1
- Expiration date of the lot/batch: 12 August 2012
- Storage condition of test material: Ca. room temperature (+20°C) in the dark

Test animals

Species:
other: n/a
Strain:
other: n/a

Test system

Type of coverage:
other: EPISKIN human epidermis skin constructs
Preparation of test site:
other: n/a
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): 100%
Duration of treatment / exposure:
15+/-0.5 minutes
Observation period:
Not applicable
Number of animals:
Not applicable
Details on study design:
See any other information below.

Results and discussion

In vivo

Results
Remarks on result:
other: Tissue viability as percentage of mean OD negative control
Irritant / corrosive response data:
Negative control
The mean absorbance of the triplicate negative control values was 0.711 which was above the minimum acceptance value of 0.6. The standard deviation of the % viability was 13.8 which was below the maximum acceptance value of 18.

Positive control
The percentage mean viability of the positive control was 12.0 ± 1.7 of the negative control. These were below the maximum acceptance values of 30% viability and SD of 18.

Test substance
It was concluded that the test substance, Diisoamyl Phthalate, with a mean tissue viability of 94.6 ± 17.3%, was predicted as non-irritant to the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was concluded that the test substance, diisopentyl phthalate, with a mean tissue viability of 94.6 ± 17.3%, was predicted as a non-irritant to the skin.
Executive summary:

The objective of this test was to assess the skin irritation potential, in vitro, of the test ubstance, Diisoamyl Phthalate.

The test substance was applied to EPISKIN human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances.

The test substance, Diisoamyl Phthalate, elicited a mean tissue viability of 94.6% and was predicted as non-irritant.