Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other:
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Official authority summary under ELINCS Notification scheme.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour

Results and discussion

Any other information on results incl. tables

The physical properties of the test substance particularly the high water solubility (HLS, 1996) and low partition coefficient (HLS, 1996) would suggest that if the substance was bioavailable it would be unlikely to pass into the central nervous system. Acute toxicology particularly the acute oral study (HLS), revealed systemic effects of the test substance in the form of clinical signs. Clear evidence of oral absorption was seen in both the acute and repeated dose studies. There was some limited evidence of absorption via the dermal route. In a 28 -day oral (gavage) study (HLS, 1998), rats were dosed with 15, 50 or 150 mg/kg/day. The 28 Day Oral Toxicity Study revealed extensive effects in the liver providing evidence of distribution and metabolism. The changes were seen in liver weight and at both macroscopic and microscopic examination, the extent of the effects followed a dosage related trend.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
There was evidence of absorption, distribution and metabolism, with the liver identified as a target organ. Furthermore there was no evidence of bioaccumulation or distribution to the central nervous system or excretion.