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EC number: 943-368-6 | CAS number: -
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- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
In vitro studies of skin and eye irritation are available for [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts].
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- Specific details on test material used for the study:
- D-glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts
- 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
- 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 - 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Isolated bovine cornea obtained from freshly slaughtered animals, age 12-48 months. Whole eyes were transported to the test facility in HBSS on ice. The eyes were carefully examined for pre-existing defects and used within 12 hours of collection.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL, undiluted
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 5 (negative control), 3 (test material) or 4 (positive control) replicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Isolated bovine cornea obtained from freshly slaughtered animals, age 12-48 months. Whole eyes were transported to the test facility in HBSS on ice.
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were carefully examined for pre-existing defects and used within 12 hours of collection.
NUMBER OF REPLICATES
5 (negative control), 3 (test material) or 4 (positve control) replicates
NEGATIVE CONTROL USED
Water for irrigation
POSITIVE CONTROL USED
Ethanol
APPLICATION DOSE AND EXPOSURE TIME
0.75 mL; 10 minutes
TREATMENT METHOD
Closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
- POST-EXPOSURE INCUBATION
2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: illuminance
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
- Other: visual observation
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in the TG was used. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean IVIS from three replicates
- Value:
- 2.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean IVIS 38.45
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Other effects:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on a mean IVIS score of 2.3, the test material [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts] does not require classification for serious eye damage or eye irritation according to the CLP Regulation.
- Executive summary:
The potential of the test material [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts] to cause serious eye damage was assessed in a BCOP assay (closed chamber method) performed to OECD 437. 0.75 mL of the test material was applied to the cornea (three replicates) for 10 minutes, followed by a 2-hour post-exposure incubation period. Corneal opacity was measured; corneal permeability was assessed using sodium fluorescein solution and measurement of absorption at 490 nm and IVIS scores calculated. Isolated corneas were also exposed in parallel to negative control (water) and positive control (ethanol) substances. A mean IVIS score of 2.3 was calculated for the test material, indicating that it does not require classification for serious eye damage or eye irritation according to the CLP Regulation. Responses to the negative and positive controls confirmed the integrity and sensitivity of the assay.
Reference
Test material | Mean IVIS 2.3 |
Positive control | Mean IVIS 38.45 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the absence of skin and eye irritation, [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts] is not predicted to be a respiratory irritant.
Justification for classification or non-classification
In vitro studies of skin irritation and eye irritation are available for [D-Glucose, reaction products with nitric acid and sodium nitrite (1:1), sodium salts].
Based on a mean tissue viability of 78.2% in an RhE skin irritation assay, the substance does not require classification for skin irritation according to the CLP Regulation.
Based on the mean IVIS score of 2.3 in a BCOP assay, the substance does not require classification for serious eye damage or eye irritation according to the CLP Regulation.
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