Registration Dossier
Registration Dossier
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EC number: 418-280-1 | CAS number: 18600-59-4 CYASORB(R) UV-3638 LIGHT STABILISER
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: assessment based on physicochemical properties of the substance and results from available toxicological studies
- Adequacy of study:
- key study
Reference
Absorption
Only limited data has been provided by ECHA and it is difficult to make a full toxicokinetic assessment. In accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7C paragraph R.7.12 (Endpoint specific Guidance), having molecular weight of< 400g/mol, low solubility in water of 0.112mg/Land a log Kow value of>4, the substance is not favorable for penetration across biological membranes.
Oral/GI absorption
There was no evidence of systemic toxicity reported in the data provided from the acute oral studies (HUNTINGDON LIFE SCIENCES LTD.,1995 (c)). There were some signs of toxicity related to dose levels which were observed in the test. And this would suggest that absorption does take place orally. There were no details of signs of toxicity observed in the 28-day oral toxicity studies(HUNTINGDON LIFE SCIENCES LTD.,1995 (d)). A sub-acute oral toxicity study gave an NOAEL of 15mg/kg bw/day. Based on the physicochemical data and available in vivo toxicological data, oral absorption is expected to be low. For chemical safety assessment purposes, an oral absorption rate of 50% is accepted.
Respiratory absorption-Inhalation
The value of mass median diameter is 23.72 µm (Chitec, 2010), and the range of particle size distribution is from 0 µm to 149 µm. This means the substance have the potential to be inhaled. . For risk assessment purposes the inhalation absorption of Chiguard 380/Chiguard 380W is set at 100%.
Dermal absorption
In the acute dermal study in rats, no signs of systemic toxicity were observed (BIODYNAMICS INC. EAST MILLSTONE, NEW JERSEY 08873,1995).The in vivo skin irritation study in rabbit shows that the substance is not ask in irritant(HUNTINGDON LIFE SCIENCES LTD.,1995 (d)).The sensitizing potential of Chiguard 380/Chiguard 380W has been investigated by 92/69/EEC Method B.6.The substance was considered to be a skin sensitiser in this test. The ECHA guidance criteria (Chapter R.7C) state that 10% dermal absorption is used when the molecular weight of the substance is >500 and the log Pow is <-1 or >4, otherwise 100% dermal absorption is used. As the molecular weight is 368.34 g/mol and the log Kow is > 4. However, in general, dermal absorption will not be higher than oral absorption, so for chemical safety assessment purposes a dermal absorption rate of 50% is accepted.
Distribution
Systemic effects were observed in the 28-day oral toxicity study with liver effects. It is therefore possible to conclude that the substance, or the metabolites, are transported.
Metabolism
No specific metabolism studies have been performed with Chiguard 380/Chiguard 380W.
Excretion
There is no evidence to indicate the route of excretion of the substance. Any test material that is not absorbed will be excreted in the faeces.
Description of key information
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
Absorption
Only limited data has been provided by ECHA and it is difficult to make a full toxicokinetic assessment. In accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7C paragraph R.7.12 (Endpoint specific Guidance), having molecular weight of< 400g/mol, low solubility in water of 0.112mg/Land a log Kow value of>4, the substance is not favorable for penetration across biological membranes.
Oral/GI absorption
There was no evidence of systemic toxicity reported in the data provided from the acute oral studies (HUNTINGDON LIFE SCIENCES LTD.,1995 (c)). There were some signs of toxicity related to dose levels which were observed in the test. And this would suggest that absorption does take place orally. There were no details of signs of toxicity observed in the 28-day oral toxicity studies(HUNTINGDON LIFE SCIENCES LTD.,1995 (d)). A sub-acute oral toxicity study gave an NOAEL of 15mg/kg bw/day. Based on the physicochemical data and available in vivo toxicological data, oral absorption is expected to be low. For chemical safety assessment purposes, an oral absorption rate of 50% is accepted.
Respiratory absorption-Inhalation
The value of mass median diameter is 23.72 µm (Chitec, 2010), and the range of particle size distribution is from 0 µm to 149 µm. This means the substance have the potential to be inhaled. . For risk assessment purposes the inhalation absorption of Chiguard 380/Chiguard 380W is set at 100%.
Dermal absorption
In the acute dermal study in rats, no signs of systemic toxicity were observed (BIODYNAMICS INC. EAST MILLSTONE, NEW JERSEY 08873,1995).The in vivo skin irritation study in rabbit shows that the substance is not ask in irritant(HUNTINGDON LIFE SCIENCES LTD.,1995 (d)).The sensitizing potential of Chiguard 380/Chiguard 380W has been investigated by 92/69/EEC Method B.6.The substance was considered to be a skin sensitiser in this test. The ECHA guidance criteria (Chapter R.7C) state that 10% dermal absorption is used when the molecular weight of the substance is >500 and the log Pow is <-1 or >4, otherwise 100% dermal absorption is used. As the molecular weight is 368.34 g/mol and the log Kow is > 4. However, in general, dermal absorption will not be higher than oral absorption, so for chemical safety assessment purposes a dermal absorption rate of 50% is accepted.
Distribution
Systemic effects were observed in the 28-day oral toxicity study with liver effects. It is therefore possible to conclude that the substance, or the metabolites, are transported.
Metabolism
No specific metabolism studies have been performed with Chiguard 380/Chiguard 380W.
Excretion
There is no evidence to indicate the route of excretion of the substance. Any test material that is not absorbed will be excreted in the faeces.
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