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Toxicological information

Acute Toxicity: oral

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

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
IUPAC Name:
hexane-1,2-diol

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 animals 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
- Fasting period before start of the study: no food was supplied 16 hour prior to test start
- Housing: Animals were kept in groups of 5 in makrolon cages, type III
- Food: tandardized food (Altromin) was given and water ad libitum
- Room temperature: 21 ±2 °C
- Relative humidity: 50-60 %
- Light/dark cycle: 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 mg/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:
no
Remarks:
Control animals are not required.
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 levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 166 mg/kg bw
Based on:
test mat.
95% CL:
>= 5 197 - <= 7 410
Key result
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:
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.
Body weight:
not reported following exposure
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:
GHS criteria not met
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.