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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:
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 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
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:
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.
292 mg/m³
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.