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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with guidelines

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD 439
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.46
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Wheat, ext., hydrolyzed
EC Number:
309-358-5
EC Name:
Wheat, ext., hydrolyzed
Cas Number:
100209-50-5
Molecular formula:
UVCB substance, not applicable.
IUPAC Name:
Wheat, ext., hydrolyzed
Details on test material:
Identification:Wheat Solubles, Hydrolyzed
Description: Light brown-yellow powder with lumps
Batch: Cargill WSH Batch A
Purity: treated as 100% pure
Stability under storage conditions: Stable

Test animals

Species:
human
Strain:
other: not applicable (in vitro human skin model)
Details on test animals or test system and environmental conditions:
EPISKIN Standard ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 10-EKIN-028).

This model is a three-dimensional human epidermis model, which consists of adult human- derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

Source: SkinEthic Laboratories, Nice, France.

Test system

Type of coverage:
other: not applicable (in vitro human skin model)
Preparation of test site:
other: not applicable (in vitro human skin model)
Vehicle:
water
Controls:
yes
Amount / concentration applied:
Skin tissue was moistened with 5 microliter of Milli-Q water and at least 10 mg of Wheat Solubles, Hydrolyzed


Duration of treatment / exposure:
Wheat Solubles, Hydrolyzed was applied directly on top of the skin tissue for 15 minutes.
Observation period:
After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed.
Number of animals:
The test was performed on a total of 3 tissues per test substance together with negative and positive controls.
Details on study design:
Batch Cargill WSH Batch A of Wheat Solubles, Hydrolyzed was a light brown-yellow powder with lumps. Skin tissue was moistened with 5 microliter of Milli-Q water and at least 10 mg of Wheat Solubles, Hydrolyzed was applied directly on top of the skin tissue for 15 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from Mfl at the end of the treatment.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Skin Corrosion tissue viability (%)
Value:
92
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 min. Max. score: 100.0. Reversibility: no data. Remarks: Non-irritant . (migrated information)

In vivo

Irritant / corrosive response data:
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Wheat Solubles, Hydrolyzed compared to the negative control tissues was 92%. Since the mean relative tissue viability for Wheat Solubles, Hydrolyzed was above 50% after 15 minutes treatment Wheat Solubles, Hydrolyzed is considered to be non-irritant.

The positive control had a mean cell viability of 6% after 15 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information