Hexanal

Acute Toxicity: oral

Administrative data

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

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.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

Principles of method if other than guideline:

Test in the rabbit eye

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Irritation parameter:

other: Grading Scheme (see above)

Score:

5

Interpretation of results:

study cannot be used for classification

Conclusions:

The eye irritation potential of test material hexanal was studied in rabbits. Under the test conditions, the test substance hexanal showed a severe burn in rabbit eyes.

Executive summary:

The eye irritation potential of test material hexanal was studied in rabbits. Under the test conditions, the test substance hexanal showed a severe burn in rabbit eyes.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1962

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1969

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Hexanal

EC Number:

200-624-5

EC Name:

Hexanal

Cas Number:

66-25-1

Molecular formula:

C6H12O

IUPAC Name:

hexanal

Test material form:

liquid

Details on test material:

Hexanal (mixed isomers)

Specific details on test material used for the study:

Hexanal (mixed isomers)

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

Effect levels 1

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

Effect levels 2

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

Applicant's summary and conclusion

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.