Carbamic acid, [(1S,2S)-3-chloro-2-hydroxy-1-(phenylmethyl)propyl]-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

20 March 1995 to 22 June 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and per OECD Guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chlorohydrine

IUPAC Name:

Chlorohydrine

Details on test material:

Physical State: solide
Storage: room temperature

Test animals

Species:

rat

Strain:

other: Crl:CD BR(SD) VAF/Plus

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sodium carboxymethyl cellulose, USP 0.5 g Polysorbate 80, NF 0.4 ml Benzyl alcohol, NF 0.9 ml Sodium chloride, USP 0.9 g Purified water, USP - qs to 100.0 ml

Doses:

0.5, 1.0 and 2.0 g/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: Maximum tolerated dose (MTD)

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

The clinical changes exhibited by rats receiving 2.0 g/kg of Chlorohydrine included: ataxia, inactivity, labored respiration, pallor, jumping, tonic and clonic convulsions, ptosis, urogenital stain, rough coat, head tilt, dehydration, unthriftiness, and wasting.

All animals survived for the duration of the study.

No changes in body weight were attributed to treatment.

There were no treatment-related gross pathologic changes.

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

When administered as a single oral dose of 2.0 g/kg, Chlorohydrine caused toxicity, but no lethality, in male and female rats. The maximum tolerated dose (MTD) in the rat after acute oral administration was approximately 2,000 mg/kg bw and thus Chlorohydrine can be classified as compound which does not present a significant acute toxic risk if swallowed.

Executive summary:

ACUTE ORAL TOXICITY STUDY OF CHLOROHYDRINE IN RATS

Purpose:

The acute oral toxicity of the chemical intermediate Chlorohydrine was investigated in CD® rats of both sexes. The study was conducted according to GLP and per OECD Guideline 401.

Unless otherwise stated, all procedures were conducted according to Syntex Standard Operating Procedures. No unforeseen circumstances affected the quality or the integrity of the study. The raw data and report for this study are maintained in Syntex archives managed from 3401 Hillview Avenue, Palo Alto, California.

Study Design:

Five male and 5 female rats each received a single oral dose of 2.0 g/kg of Chlorohydrine. The rats were necropsied after a 2-week observation period.

Results:

The clinical changes exhibited by rats receiving 2.0 g/kg of Chlorohydrine included: ataxia, inactivity, labored respiration, pallor, jumping, tonic and clonic convulsions, ptosis, urogenital stain, rough coat, head tilt, dehydration, unthriftiness, and wasting.

All animals survived for the duration of the study.

No changes in body weight were attributed to treatment.

There were no treatment-related gross pathologic changes.

Conclusions:

When administered as a single oral dose of 2.0 g/kg, Chlorohydrine caused toxicity, but no lethality, in male and female rats. The maximum tolerated dose (MTD) in the rat after acute oral administration was approximately 2,000 mg/kg bw and thus Chlorohydrine can be classified as compound which does not present a significant acute toxic risk if swallowed.