Registration Dossier
Registration Dossier
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EC number: 204-653-4 | CAS number: 123-81-9
Endpoint summary
Administrative data
Description of key information
Based on read across from a structurally related compound, GDMA is considered to be a strong sensitizer (Skin Sens 1A)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- This scenario covers the analogue approach for which the read-across hypothesis is based on (bio) transformation to common compound(s). For the REACH information requirement under consideration, the effects obtained in a study conducted with one source substance are used to predict the effects that would be observed in a study with the target substance if it were to be conducted. The same type of effect(s) or absence of effect is predicted. The predicted strength of the effects may be similar or based on a worst-case approach
The hypothesis corresponds to Scenario 1 of the RAAF. The source substance NaTG will be used to read-across two endpoints, e.g. repeated dose toxicity and toxicity to reproduction, of the target substance GDMA. Source and target substance are expected to share common metabolites. GDMA is rapidly hydrolysed after absorption into TGA and ethylene glycol, while NaTG will dissociate into TGA and sodium ion. By now, no experimental toxicokinetic data is available for GDMA. Therefore, simulated gastric acid hydrolysis as well as in vitro metabolic studies are planned to strengthen the hypothesis. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Parameter:
- EC3
- Value:
- <= 2
- Test group / Remarks:
- read across
- Remarks on result:
- positive indication of skin sensitisation based on QSAR/QSPR prediction
- Parameter:
- SI
- Value:
- 6.7
- Test group / Remarks:
- 10% NaTG
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the read-across hypothesis and the presence of two thiol groups, GDMA should be classified as Skin Sens 1A.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the read-across hypothesis and the presence of two thiol groups, GDMA should be classified as Skin Sens 1A.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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