DL-hexane-1,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - July 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well performed but results for three female animals dosed at 2043 mg/kg bw only qualitatively reported, pre-GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

study was based on draft OECD guideline

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

DL-hexane-1,2-diol

EC Number:

230-029-6

EC Name:

DL-hexane-1,2-diol

Cas Number:

6920-22-5

Molecular formula:

C6H14O2

IUPAC Name:

hexane-1,2-diol

Constituent 2

Reference substance name:

1,2-Hexanediol

IUPAC Name:

1,2-Hexanediol

Test material form:

other: colourless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age of animals at start of test: Females 45-53 days, males 36-43 days
Weight of animlas at start of test: Females 0.127-0.169 kg, males 0.127-0.169 kg
Source of animals: Hagemann, Externtal
Acclimatisation prior to test: 10 days
Animals used per dose: 5-10
Animals used in total: 63
no food was supplied 16 hour prior to test start
Animals were kept in groups of 5 in makrolon cages, type III
standardized food (Altromin) was given and water ad libitum
Room temperature 21 ±2 °C, relative humidity 50-60 %
10 hour light/14 hours dark cycle per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

volumina applied were 4.64-10.0 ml/kg bw for females and 2.15-10.0 mg/kg for male rats, equivalent to 4408-9500 mg/kg bw (females) respectively 2043-9500 mg/kg bw (males). The substance was applied pure and undiluted without vehicle by oral gavage.

Doses:

doses applied were 2043 mg/kg, 4408 mg/kg, 5339 mg/kg, 6470 mg/kg, 7838 mg/kg and 9500 mg/kg

No. of animals per sex per dose:

3 males at 2043 mg/kg
5 males and 5 females at 4408 mg/kg
5 males and 5 females at 5339 mg/kg
5 males and 10 females at 6470 mg/kg
5 males and 10 females at 7838 mg/kg
10 females at 9500 mg/kg

Control animals:

not specified

Details on study design:

Observation period after test substance administration was 14 days

Statistics:

the LD50 was determined by Probit analysis for males and graphically for females.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

6 166 mg/kg bw

Based on:

test mat.

95% CL:

>= 5 197 - <= 7 410

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 339 - <= 6 470

Based on:

test mat.

Remarks on result:

other: graphically determined

Mortality:

No mortality was observed at 2043 and 4408 mg/kg bw. At the dose of 6339 mg/kg mortality was observed (1 out of 5 males after 24 h and 3 out of 5 females at 0.5, 2 and 24 hours following exposure). At the highest dose (7838 mg/kg for males) 4 out of 5 animals died after 4 hours, respectively 5 out of 10 females at 9500 mg/kg (two 0.5 hours following exposure, one 2 hours after exposure and two 24 hours after exposure)

Clinical signs:

other: First signs of toxicity were reduction of muscular tonicity and effects on coordination capability, increasing with doses as aplied whereas mortality was described as general paralysis.

Gross pathology:

gross pathology revealed no substance specific effects in organs examined post mortem.

Any other information on results incl. tables

doses [mg/kg]	gender	mortality		0.5 h	1 h	2 h	4 h	8	24 h
4408	males	0/5	0%
6339	males	1/5	20%						1
6470	males	4/5	80%	1					3
7838	males	4/5	80%			4
4408	females	0/5	0%
6339	females	3/5	60%	1		1			1
6470	females	4/10	40%				2		2
7838	females	5/10	50%	3		1	1
9500	females	5/10	50%	2		1			2

results with 3 males dosed at 2043 mg/kg were not reported in value tables!

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

1,2-Hexanediol has an LD50, determined by OECD401 alike methodology, of 6166 mg/kg bw (males) respectively 5339-5470 mg/kg bw (females).
The value for males 6166 mg/kg bw, determined by probit analysis, is taken forward for hazard and risk assessment.

Executive summary:

In this study acute toxicity 1,2-hexanediol was investigated at high doses (4408 up to 9500 mg/kg bw). The LD50 was determined being greater 5000 mg/kg for male and female rats and thus outside boundaries for classification even under GHS (Globally Harmonized System for Classification and Labelling of Chemicals). Symptoms seen at concentrations as of 2043 mg/kg bw were reduced muscular tonicity and effects on coordination capability of animals. As only the LD50 for male rats was determined by probit analysis (LD50 of 6166 mg/kg bw), this value is considered being more reliable and taken forward for hazard and risk assessment.