Butane-1,3-diol

Endpoint summary

Description of key information

The acute toxicity of the test substance is low. This is based on oral LD50 values > 10000 mg/kg bw in several species, no lethal effects in the rat at 8 h exposure to saturated vapour concentration and a dermal LD50 > 20000 mg/kg bw as well as a low  toxicity after parenteral application. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1951

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study with sufficient details reported in former publications, but purity of the substance not stated and some study details are lacking.

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

acute oral toxicity test

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Wistar or Sherman

Sex:

male

Details on test animals or test system and environmental conditions:

- Age at study initiation: 90-120 g

Route of administration:

oral: gavage

Vehicle:

water

Doses:

geometrical series of dosis, e.g. 1, 2, 4 and 8 g/kg bw

No. of animals per sex per dose:

5

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 bya method of Thompson (reference stated) and reported +/- 1.96 standard deviations (SD)

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

22 800 mg/kg bw

Remarks on result:

other: LD50 +/- 1.96 SD: 21800-23900

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

Non-fasted male rats were given single oral doses of the test item. The LD50 (observation period: 14 days) was 22800 mg/kg bw (Smyth et al., 1951).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

22 800 mg/kg bw

Quality of whole database:

sufficient for evaluation

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1951

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study with sufficient details reported in former publications, but purity of the substance not stated and some study details are lacking.

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

acute inhalation toxicity test, similar to the inhalation hazard test described in OECD guideline 403.

GLP compliance:

no

Test type:

other: inhalation hazard test

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

exposure to saturated vapour

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 8 h

Concentrations:

saturated vapour, concentration not stated in the publication; a concentration of about 78 ppm (292 mg/m3) can be estimated based on a vapour pressure of 0.08 hPa at 20 °C.

No. of animals per sex per dose:

6 males

Control animals:

not specified

Details on study design:

The animals were exposed for up to 8 h (geometric time series with a factor of 2) to a stream of air, saturated with vapours of the test substance. The saturation was performed by passing the air through a fritted disc bubbler at room temperature. The duration of observation period following administration was 14 days.

Key result

Sex:

not specified

Dose descriptor:

LC0

Effect level:

78 ppm

Based on:

other: saturated vapour

Exp. duration:

8 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Key result

Sex:

not specified

Dose descriptor:

LC0

Effect level:

292 mg/m³ air

Based on:

other: saturated vapour

Remarks:

calculated based on a vapour pressure of 0.08 hPa at 20 °C

Exp. duration:

8 h

Remarks on result:

not determinable due to absence of adverse toxic effects

No deaths occurred.

Interpretation of results:

GHS criteria not met

Conclusions:

A single 8 h exposure to saturated vapour (concentration not stated, about 78 ppm or 292 mg/m3) produced no mortality in male rats.

Executive summary:

No lethal effects were observed in male rats after a single 8 h of exposure to saturated vapour (concentration not stated, about 78 ppm or 292 mg/m3) (Smyth et al., 1951).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

292 mg/m³ air

Quality of whole database:

sufficient for evaluation

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

insufficient for evaluation

Additional information

The available data indicate that that the oral, inhalation and dermal acute toxicity of 1,3 -BG is low.

A reliable study (key study) reports an oral LD50 of 22800 mg/kg bw in rats (Smyth et al., 1951).

The reported range of oral LD50 values in the rat is 18610-22800 mg/kg bw (Smyth et al., 1941, 1951), in the mouse is 12980-25130 mg/kg bw (Dominguez-Gil et al., 1971; Fischer et al., 1949; Loeser, 1949; Wenzel et al., 1956), and the LD50 in guinea pigs is 11640 mg/kg bw (Smyth et al., 1941).

No LD50 values could be identified for the inhalative route, but rats exposed to saturated vapour (about 78 ppm or 292 mg/m3) did not show lethal effects (Smyth et al., 1951, key study). A dermal LD50 in rabbits of >20000 mg/kg is reported in a secondary source (RL4) (ChemID, 2008). This value is supported by the absence of toxic effects after repeated dermal exposure of guinea pigs to 20 ml/kg (20100 mg/kg bw, Kopf et al., 1950). By the parenteral route, there are reported LD50 values of 20170 mg/kg bw (subcutaneous, rat; Fischer et al., 1949), 10000 mg/kg bw (intraperitoneal, rat; Sprince et al,. 1966) and 9000 mg/kg bw (intravenous, rat; BIBRA, 1990).

Justification for classification or non-classification

Based on the available data, which indicate a low acute toxicity, and according to Regulation (EC) No 1272/2008 no classification for acute toxicity is required.