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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from IARC and IPCS Monograph

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans.
Author:
World Health Organization, International Agency for Research on Cancer
Year:
1995
Bibliographic source:
IARC Monograph, World Health Organization, International Agency for Research on Cancer, V63 251 (1995)
Reference Type:
review article or handbook
Title:
CONCISE INTERNATIONAL CHEMICAL ASSESSMENT DOCUMENT NO. 25; CHLORAL HYDRATE
Author:
World Health Organisation
Year:
2000
Bibliographic source:
International Programme on Chemical Safety, Environmental Health Criteria (EHS)

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guideline
Qualifier:
according to
Guideline:
other: as mentionoed below
Principles of method if other than guideline:
The absorption, distribution, metabolism and excretion of the chemical chloral hydrate has been determined.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: 2,2,2-Trichloroethane-1,1-diol (Chloral hydrate)
- Molecular formula: C2-H3-Cl3-O2
- Molecular weight: 165.4026g/mol
- Smiles notation: C(C(O)O)(Cl)(Cl)Cl
- InChl: RNFNDJAIBTYOQL-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material: 2,2,2-Trichloroethane-1,1-diol (Chloral hydrate)
- Molecular formula: C2-H3-Cl3-O2
- Molecular weight: 165.4026g/mol
- Smiles notation: C(C(O)O)(Cl)(Cl)Cl
- InChl: RNFNDJAIBTYOQL-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid
Radiolabelling:
not specified

Test animals

Species:
other: Humans
Sex:
not specified

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on exposure:
Details not available
Duration and frequency of treatment / exposure:
Details not available
Doses / concentrations
Remarks:
Doses / Concentrations:
15 mg/kg bw
No. of animals per sex per dose:
Details not available
Control animals:
no

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
After oral administration, chloral hydrate is rapidly absorbed from the gastrointestinal tract. Its biotransformation to trichloroethanol must be rapid, since no parent compound could be detected in even the first samples taken 10 min after administration
Type:
distribution
Results:
Peak levels of trichloroethanol and trichloroethanol glucuronide were reached within 20 to 60 min after oral administration of aqueous solution.
Type:
metabolism
Results:
Chloral hydrate is rapidly metabolized in both hepatic and extrahepatic tissues to trichloroethanol and trichloroacetic acid.
Type:
excretion
Results:
The major route of excretion of the metabolites of chloral hydrate is the urine. (Source EPA)

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
trichloroethanol
trichloroacetic acid and
trichloroethanol glucuronide

Applicant's summary and conclusion

Conclusions:
Since chloral hydrate is rapidly metabolized after oral absorption to produce metabolites that are excreted predominantly in urine, it can be expected that chloral hydrate shall have low bio-accumulation potential.
Executive summary:

The absorption, distribution, metabolism and excretion of the chemical chloral hydrate has been determined. From the information available chloral hydrate is shown to be rapidly metabolized after oral absorption to produce trichloroethanol, trichloroacetic acid and trichloroethanol glucuronide metabolites that are excreted predominantly in urine, thus it can be expected that chloral hydrate shall have low bio-accumulation potential.