Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted well documented and conducted according to an OECD Guideline. The study was not conducted in compliance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Viscous liquid
Details on test material:
- Name of test material (as cited in study report): MTDID 15655
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 91.4%
- Purity test date: 21 April, 2015
- Lot/batch No.: 565093
- Expiration date of the lot/batch: 27 August, 2017

Test animals

Species:
other: in vitro reconstructured epidermal tissue model
Strain:
other: NA: in vitro method
Details on test animals and environmental conditions:
Not applicable: in vitro method

Test system

Type of coverage:
other: NA: in vitro method
Preparation of test site:
other: NA: in vitro method
Vehicle:
unchanged (no vehicle)
Controls:
other: Negative and positive control tissues were utilized
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL

VEHICLE: None
Duration of treatment / exposure:
The test material was applied to the apical surface for a period of 60 minutes, then washed with DPBS and incubated for a 42 hour period.
Observation period:
MTT assays were conducted after a 42 hour incubation period following exposure.
Number of animals:
None, in vitro method.
Details on study design:
TEST SITE
- Area of exposure: 0.6 cm2
- % coverage: 100% of the reconstructed tissue model surface was covered

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The tissues were washed after a 60 minute exposure with DPBS
- Time after start of exposure: 60 minutes

SCORING SYSTEM: An MTT reduction assay was conducted on each tissue to determine tissue viability following exposure and incubation.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Tissue viability as percent of negative control
Value:
ca. 100
Remarks on result:
other:
Remarks:
Basis: mean. Time point: Following 60 minute exposure and 42 hour post exposure incubation. Max. score: 102.0. (migrated information)

In vivo

Irritant / corrosive response data:
MTDID 15655 tissue viabilities as compared to the DPBS negative control were 99, 102, and 99 percent.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of the study indicate the test article is not irritating to the skin.
Executive summary:

To assess the human epidermal irritation potential of the test article (Viscous liquid, Lot 565093, Purity 91.4%) using the reconstructed human epidermal tissue model, EpiDerm (EPI-200-SIT). The study was not conducted under GLP conditions. The test method was based on OECD Guideline No. 439 and EpiDerm Protocol MK-24-007-0023 Rev. 3/26/2012. Replicate sets of tissues were exposed to 30 uL of test article (n=3) or control (Positive: 5% SDS, Negative: 30 uL DPBS) agents (n=3) for a period 60 minutes at which time the surface of the tissues was thoroughly washed with Dulbecco’s Phosphate-Buffered Saline (DPBS) and incubated for 42 hours. Tissue viability was determined by the Thiazolyl blue (MTT) assay. The resulting optical densities (OD) were normalized to the mean of the negative control group. Viability data is presented as a percentage of the negative control group mean. The test is considered valid if the mean OD of the MTT test extractant for the DPBS treated negative control samples is >/= 1.0 and </= 2.5, the viability of the 60 minute 5% SDS treated positive control tissues is </= 20% of the negative control, and the standard deviation (SD) for the test samples is < 18%. Test article-treated tissues showed similar MTT viability compared to the negative control (100% viability). The results of the study indicate the test article is not irritating to the skin.