(R)-(-)-butane-1,3-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 generally accepted scientific standards and described in sufficient detail

Justification for type of information:

This endpoint study record is the experimental source record for the registered target substance.

Data source

Reference

Reference Type:

publication

Title:

RANGE-FINDING TOXICITY DATA: LIST IV

Author:

Smyth HF, Carpenter CP & Weil CS

Year:

1951

Bibliographic source:

AMA Arch Ind Hyg Occup Med (1951) 4:199-122

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Lacking details in methodology and results

GLP compliance:

no

Remarks:

Study pre-dates GLP requirements

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,3-diol

EC Number:

203-529-7

EC Name:

Butane-1,3-diol

Cas Number:

107-88-0

Molecular formula:

C4H10O2

IUPAC Name:

butane-1,3-diol

Test material form:

liquid

Details on test material:

no impurities described

Test animals

Species:

rat

Strain:

other: Wistar or Sherman

Sex:

male

Details on test animals or test system and environmental conditions:

weighing 90 to 120 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Not reported. The authors state rats are given dosages differing in a ratio of 10.

No. of animals per sex per dose:

6 rats/dose group

Control animals:

not specified

Details on study design:

Single oral administration was performed in non-fasted animals with an initial start dose, derived from "experience with other substances". One week later other doses were tested with new groups of animals until two doses (differing by a factor of 10) were determined which kill some or all animals and some or no animal, respectively. The duration of observation period following administration was 14 days.

Statistics:

LD50 values (designated as "range finding LD50") were calculated by a method to Thompson (Bact. Reviews, 11: 115, 1947) and reported ± 1.96 standard devistions (SD).

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

22 800 mg/kg bw

Based on:

test mat.

Mortality:

Not reported

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity was low (LD50: 22800 mg/kg bw).

Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.

Non-fasted rats were given single oral doses. The LD50 (observation period: 14 days) was 22800 mg/kg bw.