Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Tissue distribution of monochloroacetic acid and its binding to albumin in rats
Author:
Bhupendra et al
Year:
1992
Bibliographic source:
Toxicol. Ind. Health 8(1/2), 53-61

Materials and methods

Objective of study:
distribution
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Distribution of monochloroacetic acid after a single oral gavage dose in rats. Animals were sacrificed after 4,8,12,24 and 48 hours.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloroacetic acid
EC Number:
201-178-4
EC Name:
Chloroacetic acid
Cas Number:
79-11-8
Molecular formula:
C2H3ClO2
IUPAC Name:
chloroacetic acid
Details on test material:
monochloroacetic acit (99+%, gold label) from aldrich chemical co, milwaukee, WI
1-14C-labeled monochloroacetic acid >98% pure; specific activity 2.4 mCi/mmol) from sigma chemical co, st louis, MO
Radiolabelling:
yes
Remarks:
1-14C-Monochloroacetic acid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Individual metabolism cages: yes/no
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:
TEST ANIMALS
- Source:Harlan
- Weight at study initiation: 175 g
- Individual metabolism cages: yes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
not specified
Duration and frequency of treatment / exposure:
Two groups: single oral dose
One group, daily oral dose for 3 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0.1 mmole/kg bodyweigt 1-14C-MCAA
1 mmole/kg bodyweigt 1-14C-MCAA
No. of animals per sex per dose / concentration:
3 per time point
Control animals:
no
Details on study design:
- Dose selection rationale:
Determine distribution of MCA after a single oral dose. A higher dose was applied to determine dose dependency. Dosing for 3 consecutive days was to investigate bioaccumulation
Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, plasma, kidney, liver, intestine, lung, spleen, heart, brain and testes
- Time and frequency of sampling: 4, 8, 12, 24, 48 after dosing

METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, faeces, blood, plasma, Kidney, Liver, Intestine, Lung, Spleen, Heart, Brain and Testes
- Time and frequency of sampling:4, 8, 12, 24, 48 after dosing
- From how many animals: 3 per time point, not pooled
- Method type(s) for identification: Liquid scintillation counting
- Limits of detection and quantification: not specified
Statistics:
two tailed student's t-test

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Absorbance was fast. Highest levels in intestine and kidney at 4 and 8 hours after dosing, followed by lower levels in liver, spleen, testes, lung, brain and heart in decreasing order.
Details on distribution in tissues:
See table 1 & 2
Comparable distribution patterns with the higher dose: significant increase of radiolabel present (1.4 to 3.8 times higher) in different tissues, except for liver and spleen.
Details on excretion:
Elimination phase appears to be faster for intestine and kidney compared to other tissues. Urinary excretion of MCAA and/or metabolites was 90% of the dose after 24 hours.

Metabolite characterisation studies

Metabolites identified:
yes

Applicant's summary and conclusion

Conclusions:
Dose dependent accumulation of MCA. Urinary excretion of MCAA and/or metabolites was 90% of the dose after 24 hours.