A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Materials and methods

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)

EC Number:

400-830-7

EC Name:

A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)

Cas Number:

104810-48-2

Molecular formula:

(C2H4O)nC38H40N6O5

IUPAC Name:

A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on 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 > 600 g/mol, low solubility in water of 7 mg/L (CIBA-GEIGY S.A.4002 BASEL, 1986) and a likely log Kow value of < 0 (CIBA SDS, published data), the substance is not favorable for penetration across biological membranes. The test substance has very low vapor pressure (0.000048 Pa at 25 °C) (CIBA-GEIGY S.A.4002 BASEL, 1986 (f)), so the potential for the generation of inhalable forms is low; exposure to humans via the inhalation route is also unlikely to occur.
Oral/GI absorption
The hydrolysis data (t1/2: 7.5 days at pH 4) indicates the substance is very stable. No data is available regarding test conducted at lower pHs. There was no evidence of systemic toxicity reported in the data provided from the acute oral studies (CIBA-GEIGY S.A.4002 BASEL, 1986(c)). There were no adverse effects at 5000 mg/kg as a single oral dose. Signs of toxicity observed in the 28-day and 90-day oral toxicity studies would suggest that absorption does take place orally (CIBA-GEIGY S.A.4002 BASEL, 1986(d, e)). A 28 day study indicted liver damage (necrotic foci) at 50 mg/kg. A sub-chronic oral toxicity study indicated increased liver weight, specifically in males. Clinical chemistry results indicated an increase in liver enzymes confirming this organ as a target for toxicity.
Respiratory absorption-Inhalation
There was no evidence of systemic toxicity reported in the data provided on the acute Inhalation (CIBA-GEIGY S.A.4002 BASEL, 1986(g)). When taking into account the determined melting range of <-20°C and the very low vapour pressure of 4.8×10-5 Pa (CIBA-GEIGY S.A.4002 BASEL, 1986(f)) at 25°C, evaporation of Chiguard 5530 into air is not likely to happen.
Dermal absorption
In the acute dermal study in rats, no signs of systemic toxicity were observed (CIBA-GEIGY S.A.4002 BASEL, 1986(h)). The in vivo skin irritation study in rabbit shows that the substance is not a skin irritant (CIBA-GEIGY S.A.4002 BASEL, 1986(i)). The sensitizing potential of Chiguard 5530 has been investigated by a Annex V (Maximisation test). The substance was considered to be a strong skin sensitiser in this test (CIBA-GEIGY S.A.4002 BASEL, 1986 (a)). The substance is surface active (50.5 mN/m) (CIBA-GEIGY S.A.4002 BASEL, 1986 (b)) so this may facilitate enhanced dermal exposure to the substance, which would not be indicated by the physicochemical properties above (e.g. molecular weight, log Kow).

Details on distribution in tissues:

Systemic effects were observed in the 28-day and 90-day oral toxicity study with liver effects (CIBA-GEIGY S.A.4002 BASEL, 1986(d, e)). It is therefore possible to conclude that the substance, or the metabolites, are transported.

Details on 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.