Oxidation products of D-Glucose with nitric acid, sodium salts

Skin irritation / corrosion

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

Test material information

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.