Hexanal

Endpoint summary

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 for cross-reference:

reference to same study

Reason / purpose for cross-reference:

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 or test system 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:

other: 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 for cross-reference:

reference to same study

Reason / purpose for cross-reference:

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 or test system 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:

other: 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.