Ethane-1,2-diol

Endpoint summary

Description of key information

BASF (1968) reported an acute oral LD50 value of 7712 mg/kg for male and female rats.

Tyl (1985) reported an acute inhalative LC50 value of > 2.5 mg/L air for a six-hour exposure for male and female rats.

An acute dermal LD50 value of > 3500 mg/kg for male and female mice was derived by Tyl (1988).

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Early study report, short study description.

Qualifier:

no guideline followed

Principles of method if other than guideline:

according to BASF-internal standards

GLP compliance:

no

Limit test:

no

Specific details on test material used for the study:

30% solution in aqua dest.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

3200, 6400, 8000, 10000 mL/Kg bw

No. of animals per sex per dose:

20

Control animals:

no

Details on study design:

Recording of symptoms for 7 days after application.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

7 712 mg/kg bw

Based on:

test mat.

Mortality:

Dead animals after 7 days observation period:
19/20 in 10000 mL/kg bw dose group
16/20 in 8000 mL/kg bw dose group
5/20 in 6400 mL/kg bw dose group
0/20 in 3200 mL/kg bw dose group

Clinical signs:

other: depression, narcosis.

Gross pathology:

Animals that died: kidney damage

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

7 712 mg/kg bw

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

LC50 value derived from teratogenicity study.

GLP compliance:

yes

Test type:

other: LC50 value derived from teratogenicity study

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

see 7.8.2 Developmental toxicity / teratogenicity

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Details on inhalation exposure:

see 7.8.2 Developmental toxicity / teratogenicity

Duration of exposure:

6 h

Concentrations:

60, 400 or 1000 ppm
150, 1000 or 2500 mg/m3 (0.15, 1.00 or 2.5 mg/L)

No. of animals per sex per dose:

see 7.8.2 Developmental toxicity / teratogenicity

Control animals:

yes

Details on study design:

see 7.8.2 Developmental toxicity / teratogenicity

Statistics:

see 7.8.2 Developmental toxicity / teratogenicity

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.5 mg/L air

Based on:

test mat.

Exp. duration:

6 h

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating conc.

Value:

2 500 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

LD50 derived from developmental toxicity study.

GLP compliance:

yes

Test type:

other: LD50 derived from developmental toxicity study

Limit test:

no

Species:

mouse

Strain:

CD-1

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

water

Duration of exposure:

see developmental toxicity/teratogenicity

Doses:

approx. 404, 1677 and 3549 mg/kg bw

No. of animals per sex per dose:

see developmental toxicity/teratogenicity

Control animals:

yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 500 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

3 500 mg/kg bw

Additional information

Acute oral toxicity:

BASF (1968) reported an acute oral LD50 value of 7712 mg/kg for male and female rats. Animals were given doses of about 3200, 6400, 8000 and 10000 µL/kg. Clinical signs seen were depression and narcosis. No mortalities were seen in the low dose group, 5 of 20 rats died in th 6400 µL/kg dose group, 16 of 20 rats died in the 8000 µL/kg dose group and 19 of 20 rats died in the 10000 µL/kg dose group.

Acute inhalation toxicity:

BASF (1961) reported an inhalation hazard test. Rats inhaled a saturated atmosphere at 20°C for 8 hours. No symptoms and no mortalities were observed.

Tyl (1985) reported a teratogenicity study using rats and mice. Concentrations of 0.15, 1 or 2.5 mg/L were given as aerosol concentrations using male and female rats. From this study, an acute inhalative LC50 value was derived being > 2.5 mg/L air for a six-hour exposure for male and female rats.

According to the results mentioned above, classification proposal concerning acute inhalation toxicity could not be done.

Acute dermal toxicity:

Tyl (1988) reported a developmental toxicity study using mice. Male and female animals were given doses of about 404 mg/kg, 1677 mg/kg and 3549 mg/kg under occlusive conditions. From this study, an acute dermal LD50 value of > 3500 mg/kg for male and female mice was derived.

According to the results of this developmental toxicity study, classification regarding acute dermal toxicity is not warranted.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The substance is legally classified for acute toxicity category 4 (H302: "Harmful if swallowed") according to Annex VI CLP Regulation. However, regarding available reliable experimental test data provided in this dossier the substance would not need to be classified for acute toxicity under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182.