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Diss Factsheets

Administrative data

Description of key information

Skin:

QSAR. Unlikely to be irritating to skin. Reliability = 2;

OECD 402, not irritating to skin. Reliabiity = 1;

Human Repeat Insult Patch Test. No irritation noted in 103 subjects. Reliability = 2.

Eye: QSAR. Unlikely to be irritating to the eye. Reliability = 2

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Qualifier:
no guideline available
Principles of method if other than guideline:
TIMES v2.27.17.6 in QSAR Toolbox
Toolbox prediction report is attached in IUCLID
GLP compliance:
no
Specific details on test material used for the study:
Smiles: OCC{P-}(O)C{P-}(O)C{P+}(O)C{P+}(O)C=O
Irritation parameter:
other: QSAR skin irritation corrosion
Remarks on result:
no indication of irritation
Remarks:
Model indicates that the test substance is unlikely to be irritating to the skin
Interpretation of results:
GHS criteria not met
Conclusions:
Model indicates that the test substance is unlikely to be irritating to the skin.
Executive summary:

The TIMES model for skin irritation/corrosion was used within the QSAR Toolbox. Model indicates that the test substance is unlikely to be irritating to the skin. Additional supporting documentation is provided in the prediction report attached in IUCLID.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
Qualifier:
no guideline available
Principles of method if other than guideline:
TIMES v.2.27.17.6 in QSAR Toolbox
Toolbox prediction report is attached in IUCLID
GLP compliance:
no
Specific details on test material used for the study:
Smiles: OCC{P-}(O)C{P-}(O)C{P+}(O)C{P+}(O)C=O
Irritation parameter:
other: QSAR Eye irritation model
Remarks on result:
no indication of irritation
Remarks:
Model indicates that the test substance is unlikely to be irritating to the eye
Interpretation of results:
GHS criteria not met
Conclusions:
Model indicates that the test substance is unlikely to be irritating to the eye.
Executive summary:

The TIMES model for in vivo eye irritation was used within the QSAR Toolbox. Model indicates that the test substance is unlikely to be irritating to the eye. Additional supporting documentation is provided in the prediction report attached in IUCLID.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The Times model for skin irritation/corrosion was used within the QSAR Toolbox. The model indicates that the test substance is unlikely to be irritating to the skin. In an in vivo, dermal toxicity study, a single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose level of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. There were no instances of oedema and only slight erythema observed during the study. The erythema would not meet GHS criteria for classifying for skin irritation. Additionally, a leave-on facial product containing 5% of the test substance was examined in a Human Repeated Insult Patch Test (HRIPT) with 48-72 h occlusive patches. No irritation reaction was observed in any of the 103 subjects. Therefore, based on the data available, the test substance is not expected to be irritating to the skin.

 

The Times model for in vivo eye irritation was used within the QSAR Toolbox. The model indicates that the test substance is unlikely to be irritating to the eye.

Justification for classification or non-classification

Based on QSAR and in vivo tests in rats and humans, the test substance is unlikely to be irritating to the skin. Based on QSAR model, the test substance is unlikely to be irritating to the eye.  Therefore, the substance does not need to be classified for skin or eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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