Registration Dossier

Administrative data

Description of key information

oral

non-guideline standard acute method, rat, single dose (gavage), 14 days, LD50 = 7703 mg/kg bw

dermal

non-guideline standard acute method, rabbit, single dose (24 h occlusive), 14 days, LD50 = 8100 mg/kg bw

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Hexanal (mixed isomers)
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: reared in own colony
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: none
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no details given
Doses:
The dosages are arranged in a logarithmic series differing by a factor of two.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil.
Sex:
male
Dose descriptor:
LD50
Effect level:
9.51 mL/kg bw
Based on:
test mat.
Remarks on result:
other: fiducial range: 5.84 - 15.5
Key result
Sex:
male
Dose descriptor:
LD50
Remarks:
calculated from mL based on density of hexanal (8.1 mg/mL)
Effect level:
7 703.1 mg/kg bw
Based on:
test mat.
Mortality:
no details given
Clinical signs:
no details given
Body weight:
no details given
Gross pathology:
no details given
Other findings:
no details given
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 = 7703.1 mg/kg body weight
Executive summary:

The single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats following a standard acute method decsribed in sufficient detail. The LD50 for mixed isomers of hexanal was determined to be 7703.1 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 703 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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:
reference to same study
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Penetration of rabbit skin is estimated by a technique closely akin to the one-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 mL/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: impervious plastic film

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
not specified
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 8 100 mg/kg bw
Based on:
test mat.
Mortality:
not specified
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 8100 mg/kg bw
Executive summary:

Penetration of rabbit skin is estimated by a technique closely akin to the one-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 mL/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 was >8100 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 100 mg/kg bw

Additional information

oral

The oral LD50 values found in literature for rats and mice are well above 2000 mg/kg bw:

Tovar G (1977): LD50 in mice = 82.79 mmol/kg bw = 8292.33 mg/kg bw

Smyth (1954): LD50 in rats = 4290 mg/kg bw

Merck Index (1968): LD50 in rats = 5000 mg/kg bw

Fassett (1963): LD50 in rats = 4900 mg/kg bw

These results confirm the reliability of the LD50 value of 7703 mg/kg bw obtained in the key study.

Justification for classification or non-classification

Based on the available data, the registered substance does not require classification and labelling for lethal effects following a single oral exposure or dermal exposure according to Regulation (EC) No 1272/2008.