Chloroacetic acid

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Each animal received a single dose of test chemical in distilled water. Animals were sacrificed 4 hours after treatment. Animals were sacrificed, and cell pellets of liver, intestine and stomach were lysed for 1 hour. Solutions were neutralized, and sonicated. Single and double stranded DNA repair were separated on a hydroxylapatite column at 60°C. Hoechst Dye 33258 was added and the amount of DNA in each fraction was determined fluorimetrically. The fraction of double stranded (ds) DNA remaining after alkaline unwinding in the sample is calculated by dividing the amount of ds DNA by the total (ss + ds) DNA.

GLP compliance:

not specified

Type of assay:

other: DNA alkaline unwinding assay

Test material

Test material information

Constituent 1

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:

No further data

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Wilmington, MA, USA
- Age at study initiation: no data
- Weight at study initiation: 30-35 g prior to acclimatization for 2 weeks.
- Assigned to test groups randomly: [no/yes, under following basis: ] no data
- Fasting period before study: no fasting period
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 2 °C
- Humidity (%): 40-60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

Distilled water.

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: test chemical was dissolved in distilled water

Duration of treatment / exposure:

Animals were sacrificed 4 hours after treatment

Frequency of treatment:

Once

Post exposure period:

4 hours

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 other: mmol/kg

Doses / concentrations 2

Dose / conc.:

10 other: mmol/kg

No. of animals per sex per dose:

2 animals per dose

Control animals:

yes, concurrent vehicle

Positive control(s):

- Methylmethanesulfonate
- Route of administration: oral
- Doses / concentrations: 1 mmol/kg

Examinations

Tissues and cell types examined:

liver, stomach, duodenum

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: doses up to 1/4 to 1/3 of the LD50

METHOD OF ANALYSIS: Cell pellets of liver, intestine and stomach were lysed for 1 hour. Solutions were neutralized, and sonicated. Singel and double stranded DNA repair were separated on a hydroxylapatite column at 60°C. Hoechst Dye 33258 was added and the amount of DNA in each fraction was determined fluorimetrically. The fraction of double stranded (ds) DNA remaining after alkaline unwinding in the sample is calculated by dividing the amount of ds DNA by the total (ss + ds) DNA.

Evaluation criteria:

No data

Statistics:

Dunnett's test for multiple comparison of treatment means with a control mean. Level of significance was set at < 0.05

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RESULTS OF STUDY
No significant increase in DNA strand breaks following exposure to 1 or 10 mmol/kg MCA

Applicant's summary and conclusion

Conclusions:

MCA did not induce DNA strand breaks following oral exposure to male B6C3F1 mice and is considered not mutagenic in this in vivo study.