Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: predictions from Basic Data set
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A qualitative assessment of the toxicokinetics of the substance has been performed, based upon its physical properties and the results of toxicological studies.

Data source

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Test guideline
Qualifier:
according to
Guideline:
other: Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance Version 2.0 November 2014
GLP compliance:
no

Test material

Radiolabelling:
no

Results and discussion

Metabolite characterisation studies

Metabolites identified:
no

Bioaccessibility

Bioaccessibility testing results:
key physical properties:
Molecular weight: 189.21
Water solubility: 26.4 g/L
Partition co-efficient log Pow: 0.832
Particle size distribution: 69.6% (<100 µm), 18.6% (<10 µm)
Dissociation constant: not determined
pH (10% suspension ): not determined
Hydrolysis: <10% at all pH tested
Structural alerts- readily ionisable groups (carboxylic and amino) present

Any other information on results incl. tables

Acute oral toxicity- discriminating dose 2000 mg/kg bw: No adverse effects were observed at the highest dose.

Acute dermal toxicity- discriminating dose 2000 mg/kg bw. No deaths or any other adverse effects were observed at the highest dose.

Acute inhalation toxicity- discriminating dose 5 mg/ L / 4 hr. the LC50 4hr cut-off value exceeds 12.5 mg/L.

28 day oral repeat dose toxicity: Surviving 1000 mg/kg/day males showed dark liver at terminal kill.

Females treated with 1000 mg/kg/day and animals of either sex from the 150 or 15 mg/kg/day treatment group showed no treatment-related macroscopic abnormalities at terminal kill. NOAEL determined ot be 150 mg/kg bw/day.

Reproductive Toxicity Screening: No effects were noted at the highest dose tsted (500mg/kg bw/day)- NOAEL determined to be 500 mg/kg bw/day.

skin exposure: slight erythema was noted in guinea pigs exposed topically during the induction pahse of the Maximisation test, no effects were noted during the rabbit skin irritation test.

Applicant's summary and conclusion