[No public or meaningful name is available]

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: assessment report

Adequacy of study:

key study

Study period:

The assessment was conducted in April 2013.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetic assessment has been conducted for the substance, FAT 65088/A TE. Summaries of studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII, point 8.8 of REACH.

The assessment of the likely toxicokinetic behaviour of the substance was provided to the extent that can be derived from the relevant available information at the time of the assessment. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, November 2012).

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

TEST ITEM
Description and Identification
Sponsor’s identification : FAT 65088/A TE
Description : Light yellow powder

Phys-Chem and Toxicological Properties
Molecular Weight : 1233.30 g/mol
Water Solubility : 37.7 g/L at 20°C + 0.5 °C
Partition coefficient : Log10 Pow -2.18
Vapour Pressure : < 1.2 x 10-19 Pa at 25°C
Acute Oral Toxicity : LD50 > 2000 mg/kg body weight
Acute Dermal Toxicity : LD50 > 2000 mg/kg body weight
Skin Irritation : Non-irritating to the skin
Eye Irritation : Non-irritating to the ocular
Skin Corrosivity : Non corrosive
Skin Sensitization : Negative
Ames test : Negative
Chromosomal Aberration Test : Negative

Radiolabelling:

no

Test animals

Species:

other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

Details on test animals or test system and environmental conditions:

Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

Administration / exposure

Route of administration:

other: not applicable

Vehicle:

unchanged (no vehicle)

Details on exposure:

Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

Duration and frequency of treatment / exposure:

Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

Doses / concentrations

Remarks:

Doses / Concentrations:
Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

No. of animals per sex per dose / concentration:

Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

Control animals:

other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Adsorption:
Although the test item has a high water solubility (37.7 g/L at 20°C + 0.5°C; Walker, 2014), it is lipophobic in nature and has a large molecular weight (1233.30 g/mol), therefore absorption through passive diffusion through the skin or gastro-intestinal tract is unlikely to be a significant route of absorption.

The proportion of the test item having an inhalable particle size of less than 100 μm was determined to be 70.8%. The proportion of the test item having a respirable particle size of less than 5.5 μm was determined to be <0.252%, therefore the test item may be inhalable but is considered not to be respirable (Walker, 2014). The low vapour pressure value (<1.2 x 10-19 Pa at 25°C; Tremain, 2014) also shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.

Details on distribution in tissues:

Distribution
The lack of evidence to suggest the test item is a sensitizer suggests that it does not bind to circulatory proteins. The low log octanol/water partition coefficient (log10 Pow -2.18; Walker, 2014) and high water solubility (37.7 g/L at 20°C + 0.5°C; Walker, 2014) would also suggest that the test item is not lipophillic and would not accumulate in body fat.

Details on excretion:

Excretion:
There are no repeated dose studies to indicate the route of excretion but high water soluble products are not favourable for biliary excretion and therefore urinary excretion may well be a significant route for this material. Any test item that is not absorbed will be excreted in the faeces.

Metabolite characterisation studies

Metabolites identified:

no

Details on metabolites:

Metabolism:
There are no repeated dose studies available to indicate if the test item is influenced by hepatic metabolism. The results of the genotoxicity assays have shown that genotoxicity is neither enhanced or diminished in the presence of the S9 metabolising system (Bowles, 2014; Thompson, 2014).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
The available information suggests that absorption of the test substance through the skin or gastro-intestinal tract is unlikely or very limited. If absorbed, the substance may be distributed in the serum. Elimination in urine may be the significant route of excretion for material that is absorbed.

Executive summary:

The available information suggests that the substance is not readily available via the oral route. This is supported by the physico-chemical properties of the substance. If any absorption occurs, the substance would be distributed systemically in the serum. Urinary excretion is considered to be the significant route for the substance.