Octanal

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not compliant with any guidelines or GLP; endpoint sufficient for hazard classification.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1962

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was applied to test sites on the shaved trunk of New Zealand White albino rabbits for an exposure period of 24 hours.
The assays included in the paper are all intended to provided initial screening information and so do not comply with the requirements of test guidelines subsequently published

GLP compliance:

no

Remarks:

conducted prior to adoption of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-Octanal

IUPAC Name:

1-Octanal

Constituent 2

Reference substance name:

Octanal

EC Number:

204-683-8

EC Name:

Octanal

Cas Number:

124-13-0

Molecular formula:

C8H16O

IUPAC Name:

octanal

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): 1-Octanal

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not documented
- Age at study initiation: Not documented
- Weight at study initiation: 2.5 to 3.5kg
- Fasting period before study: Not documented
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
No details provided in publication

IN-LIFE DATES: No details provided in publication

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: Entire trunk shaved free of hair
- % coverage: Not documented
- Type of wrap if used: Impervious plastic film

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Up to 20 ml/kg can be aplied by this method but greater volumes cannot be retained suitably on the dorsum

Duration of exposure:

The test animals were exposed to the test substance for a 24 hour contact period.

Doses:

Up to 20 ml/kg

No. of animals per sex per dose:

4 male test animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not documented
- Necropsy of survivors performed: Not documented
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Not documented

Statistics:

No information provided

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

6.35 mL/kg bw

Based on:

test mat.

95% CL:

> 4.7 - < 8.59

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

5 207 mg/kg bw

Based on:

test mat.

Mortality:

No information provided

Clinical signs:

other: No information provided

Gross pathology:

No information provided

Other findings:

No information provided

Any other information on results incl. tables

No additional information provided

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the LD50 of 1-Octanal, was determined to be 6.35 ml/kg bw which is equivalent to 5207 mg/kg bw . Based on this result, the test substance does not warrant any classification in accordance with Regulation EC No. 1272/2008.

Executive summary:

In a study conducted by Smyth et al (1962) 1-Octanal, was tested for its ability to cause acute dermal toxicity when applied to male New Zealand White albino rabbits. The entire trunk of each test animal was shaved prior to application of the test material and the test substance was applied. An impervious dressing was applied to the test site and remained in place for the 24 hours exposure period. During this exposure period, the test animals were placed in restraint tubes. Following exposure, the test animals were placed in cages for the 14 day observation period. Under the conditions of this study, the LD50 of 1-Octanal, was determined to be 6.35 ml/kg bw, equivalent to 5207 mg/kg bw. Based on this result, the test substance does not warrant classification for acute dermal toxicity in accordance with Regulation EC No. 1272/2008.