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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.