Registration Dossier
Registration Dossier
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EC number: 700-043-1 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- assessment of toxicokinetic behavior
- Type of information:
- other: an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed with a view to fulfilling the requirements of Annex VIII (8.8.1).
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Conclusions:
- Interpretation of results (migrated information): high bioaccumulation potential based on study results
Reference
Test material: OH-mPDMS
The test material consists of two ester groups, a relatively high molecular weight colourless liquid. The low vapour pressure value shows that the test material is not volatile therefore exposure to volatile products, via inhalation is unlikely. The test material is expected to undergo hydrolysis under physiological conditions which means that the parental compound may only be present in the gastro-intestinal or respiratory tracts for a limited period of time. Besides to this, the test material is not readily biodegradable which means that exposure to degradants, following oral ingestion is unlikely to occur. The test material has a high log octanol/water partition coefficient value that suggests that the substance is a high lipophilic compound which would pass across biological membranes and be absorbed by micellular solubilisation.
Absorption
The results of the acute and repeated oral toxicity studies in the rat show that the test material is either of low inherent toxicity or there is no significant absorption of the parent material. The possible lack of absorption may be a consequence of the hydrolysis of the test material under physiological conditions. The physical properties of the test material such as high molecular weight, high log Pow, low water solubility groups would not allow absorption of parental compound from the gastro-intestinal tract and the skin. Low volatility of the substance suggests that the test material would not be available for inhalation. The results of an acute dermal toxicity study in the rat show no significant toxicity, which may suggest a lack of toxicity, or that the skin is not a significant route of exposure due to low volatility of the test substance.
Distribution
There is no significant evidence to suggest that there is systemic distribution of the test material. The evidence of a positive response from the guinea pig skin sensitisation study can suggest that the test material might bind to proteins in the circulatory system. The high log octanol/water partition coefficient and non-degradability may suggest that the test material may distribute into cells and accumulate in body fat.
Metabolism
The results of the repeat oral toxicity study in the rat did not show any evidence of enhanced metabolism. The test material does not readily degrade and therefore it is likely to require further metabolism prior to excretion. The results of thein vitrogenotoxicty studies show that genotoxicity is neither enhanced nor diminished in the presence of S9 metabolising system.
Excretion
There is no evidence to indicate the route of excretion but poor water-soluble products with high molecular weights are not favourable for urinary excretion. Any test material that is not absorbed will be excreted in the faeces.
Description of key information
See discussion.
Key value for chemical safety assessment
- Bioaccumulation potential:
- high bioaccumulation potential
Additional information
Test material: OH-mPDMS
The test material consists of two ester groups, a relatively high molecular weight colourless liquid. The low vapour pressure value shows that the test material is not volatile therefore exposure to volatile products, via inhalation is unlikely. The test material is expected to undergo hydrolysis under physiological conditions which means that the parental compound may only be present in the gastro-intestinal or respiratory tracts for a limited period of time. Besides to this, the test material is not readily biodegradable which means that exposure to degradants, following oral ingestion is unlikely to occur. The test material has a high log octanol/water partition coefficient value that suggests that the substance is a high lipophilic compound which would pass across biological membranes and be absorbed by micellular solubilisation.
Absorption
The results of the acute and repeated oral toxicity studies in the rat show that the test material is either of low inherent toxicity or there is no significant absorption of the parent material. The possible lack of absorption may be a consequence of the hydrolysis of the test material under physiological conditions. The physical properties of the test material such as high molecular weight, high log Pow, low water solubility groups would not allow absorption of parental compound from the gastro-intestinal tract and the skin. Low volatility of the substance suggests that the test material would not be available for inhalation. The results of an acute dermal toxicity study in the rat show no significant toxicity, which may suggest a lack of toxicity, or that the skin is not a significant route of exposure due to low volatility of the test substance.
Distribution
There is no significant evidence to suggest that there is systemic distribution of the test material. The evidence of a positive response from the guinea pig skin sensitisation study can suggest that the test material might bind to proteins in the circulatory system. The high log octanol/water partition coefficient and non-degradability may suggest that the test material may distribute into cells and accumulate in body fat.
Metabolism
The results of the repeat oral toxicity study in the rat did not show any evidence of enhanced metabolism. The test material does not readily degrade and therefore it is likely to require further metabolism prior to excretion. The results of thein vitrogenotoxicty studies show that genotoxicity is neither enhanced nor diminished in the presence of S9 metabolising system.
Excretion
There is no evidence to indicate the route of excretion but poor water-soluble products with high molecular weights are not favourable for urinary excretion. Any test material that is not absorbed will be excreted in the faeces.
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