Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02/12/2016-03/17/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
July 2015
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Oxidation products of D-Glucose with nitric acid, sodium salts
Molecular formula:
Reaction products consisting mainly of sodium salts of D-glucarate, mono, di and tri carboxylic acids and keto gluconates. See remarks
IUPAC Name:
Oxidation products of D-Glucose with nitric acid, sodium salts
Test material form:
liquid
Specific details on test material used for the study:
D-glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Source strain:
other: not relevant
Justification for test system used:
MatTeK EpiDerm(TM) is a validated RhE model specified by the OECD Guideline
Vehicle:
unchanged (no vehicle)
Details on test system:
EpiDerm(TM) Tissue Models (MAtTek)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
30 microlitres
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
All exposures were performed in triplicate

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
78.2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
100.0%
Positive controls validity:
valid
Remarks:
3.4%
Remarks on result:
no indication of irritation
Remarks:
78.2% viability
Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes

Any other information on results incl. tables

The average viability for the test material was 78.2%, showing a lack of skin irritation potential. Appropriate viability results for the negative control (100.0%) and positive control (3.4%) confirmed the sensitivity of the assay to detect skin irritants.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
D-glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts
Executive summary:

The skin irritation potential of the substance [D-glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts] was assessed in vitro in a study performed to GLP and OECD 439. 30 µL of the undiluted test material was applied to triplicate tissues (MatTex EpiDerm(TM) for 1 hour, prior to a 42 -hour post-exposure incubation period. Tissue viability was assessed by MTT reduction and measured photometrically. The mean viability of the treated tissue samples was 78.2%. Appropriate viability results for the negative control (100.0%) and positive control (3.4%) confirmed the sensitivity of the assay to detect skin irritants. D-glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts was found to be non-irritant under the conditions of this study, and does not require classification for skin irritation according to the CLP Regulation.