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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.