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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2014-03-04 to 2014-07-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
2013
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008 of 30 May 2008, Part B (In Vitro Skin Corrosion: Human Skin Model Test) (2008)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
other: human epidermis model (EpiDermTM)
Details on test animals and environmental conditions:
Test system
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm2) are cultured on specially prepared cell culture inserts and commercially available as kits (EpiDermTM 200).
Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
water
Controls:
other: Control tissues were treated with 50 μL of de-ionized water (negative control) or with 50 μL of 8 N potassium hydroxide (positive control).
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 25 µL
- Concentration: 50 % (v/v) in water

VEHICLE
- Amount applied: 25 µL de-ionized water
Duration of treatment / exposure:
3 min and 1 hour
Observation period:
After removal of the test substance, the tissues were incubated with MTT solution for 3 hours. Afterwards formazan production was measured.
Number of animals:
Two tissues per exposure time and test group (test material, positive and negative substance) were used.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: viability [% of negative control]
Basis:
mean
Time point:
other: 3 min
Score:
100
Irritation parameter:
other: viability [% of negative control]
Basis:
mean
Time point:
other: 1 hour
Score:
113
Irritant / corrosive response data:
Evaluation of results:
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50 %. In addition, those materials with a viability of ≥ 50 % after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15 %. Therefore, the test substance is not considered to be corrosive in this study.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU