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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
1-Hexanol
Adequacy of study:
key study
Study period:
The study was conducted in 1968.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across information
Justification for type of information:
The full read-across document can be found in the Endpoint Summary in text and in the attached file.
Reason / purpose:
read-across source
GLP compliance:
no
Test type:
other: Read across information
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
720 - 1 800 mg/kg bw
Based on:
test mat.

Data source

Reference
Reference Type:
publication
Title:
Studies in kaffircorn malting and brewing. XXII. The acute toxicity of some fusel oils found in Bantu beer.
Author:
Purchase, I.
Year:
1969
Bibliographic source:
South African Medical Journal

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Four rats were used instead of five; their weight was lower than recommended in the guideline; rats were starved for 24 instead of 12 h; it is not reported how many doses were used; rats were killed after 10 instead of 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Rats weighed between 60 and 100 g.
The animals were starved for 24 h prior to dosing.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Diola was administered by gavage. Doses of less than 0.1 ml were made up to 0.25 ml with the vehicle.

Doses:
The range of doses used in this study was selected after a preliminary experiment had established the approximate degree of toxicity. The log interval between doses was constant, allowing the LD50 values to be calculated. The dose ranges used were 440-8800 mg/kg in males and 90-4400 mg/kg in females.
No. of animals per sex per dose:
4 rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Necropsy of survivors performed: yes, at death or at the end of the observation period. Portions of heart, liver, lung and kidney from representative rats in each group were fixed in buffered formalin and embedded in wax. Sections were stained with haematoxylin and erythrosin.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
720 mg/kg bw
Based on:
test mat.
Remarks on result:
other: This value will be taken forward to the risk assessment
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 800 mL/kg bw
Based on:
test mat.
Mortality:
Most rats receiving a lethal dose died within 24, only two surviving to 4 to 5 days.
Clinical signs:
No observations
Body weight:
No information provided.
Gross pathology:
Histological examination of the liver sections showed hyperaemia in the animals dying within 24 hrs, and in a few rats a slight fatty infiltration. The sections from other rats were essentially normal. There was no difference between the males and females in this respect. In the kidney at the lowest dose, hyperaemia and cloudy swellings were present in the cortex and hyperaemia in the medulla. At the next dose, pyknosis was present in the tubular cells of the medulla of the kidney. These changes were more advanced in the kidney at higher doses, with marked medullary necrosis and hyperaemia and cloudy swelling, cast formation and hyperaemia in the cortex in the highest dose range.
Other findings:
No other findings were noted.

Applicant's summary and conclusion

Interpretation of results:
other: Acute Oral Category 4
Remarks:
According to EU CLP 1272/2008 and its amendments.
Conclusions:
The acute oral LD50 for the substance in male and female rats was 1800 and 720 mg/kg bw. The value of 720 mg/kg bw is taken forward in the risk assessment being the more conserative value.
Executive summary:

Acute oral toxicity with the 1-Hexanol was performed similar to the guideline OECD TG 401. Four rats (females and males) were used per dose. They were administered the substance at dose levels of 440 -8800 mg/kg in males and 90-4400 mg/kg in females. These doses were selected based on a preliminary study. Mortality occurred most in the first day after dosing. In the liver hyperaemia (increased blood flow) was found. Hyperaemia was also seen in the kidneys in the cortex and more pronounced in the medulla. At the mid and high dose also pyknosis was seen in the tubular cells of the medulla, indicating cell death. The acute oral LD50 for 1-Hexanol in males was 1800 and in females 720 mg/kg bw. The LD50 is set as 720 mg/kg bw being the most conservative value.