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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
grey literature
Title:
Unnamed
Report date:
2002

Materials and methods

Principles of method if other than guideline:
Repeated dose toxicology studies - Method not available
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
L-Lysine, 2-[[1-(phenylmethyl)-1H-indazol-3-yl]oxy]acetate (1:1)
EC Number:
617-268-5
Cas Number:
81919-14-4
Molecular formula:
C22H28N4O5
IUPAC Name:
L-Lysine, 2-[[1-(phenylmethyl)-1H-indazol-3-yl]oxy]acetate (1:1)

Test animals

Species:
other: mouse, rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
From 1 to 3 months
Frequency of treatment:
once a day

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

 Regimen  Species  No. animals tot (x dose)  Dose (mg/kg bw)  Results
 in the diet for 3 months  mouse/CDI  80 (20)  0, 150, 300, 600  lower body weight gains in males of all groups, high liver weight in 300 (F) and 600 (MF) mg groups; mortality: 1 male at 600 mg
  in the diet for 1 months  rat/CD SD  40 (10)   0, 600, 900, 1500   lower body weight gains in all groups, hepatocyte enlargement at 1500 mg; mortality: 2 female at 1500 mg
  in the diet for 2 months  rat/CD SD  40 (10)  0, 50, 200, 400  lower body weight gains at 400 mg
  in the diet for 3 months  rat/CD SD  96 (24)  0, 100, 300, 900  increase in liver function parameters at 900 mg; increase in liver weights
  in the diet for 3 months  rat/Slc:SD  200 (40)  0, 125, 250, 500, 1000  dose-related decrease of hematocrit; dose-related increase of alk.phosphatase and of liver and kidney weights, liver vacuolar degeneration at 1000 mg; mortality: 11 males and 12 females at 1000 mg.

Applicant's summary and conclusion