Reaction mass of 1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 1-methyl-3-(4-methylpentyl)-3-cyclohexene-1-carboxaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October, 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study meets the EC Standards (conducted equivalent to OECD 402). Non GLP. Deviations: lack of study design details in the report, no details on test material, limited details on test animals and environmental conditions. Only a very short description is reported. However, dose, number of animals and observation period and considering mortality observed, the result is considered reliable with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

lack of study design details in the report, no details on test material, limited details on test animals and environmental conditions.

GLP compliance:

no

Remarks:

not present at the time of performance

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

EC Number:

266-314-7

EC Name:

1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Cas Number:

66327-54-6

Molecular formula:

C14H24O

IUPAC Name:

1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Constituent 2

Reference substance name:

1-methyl-3-(4-methylpentyl)-3-Cyclohexene-1-carboxaldehyde

Cas Number:

693252-50-5

Molecular formula:

C14H24O

IUPAC Name:

1-methyl-3-(4-methylpentyl)-3-Cyclohexene-1-carboxaldehyde

impurity 1

Reference substance name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, trans-

Cas Number:

76169-46-5

Molecular formula:

C14H26O

IUPAC Name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, trans-

impurity 2

Reference substance name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, cis-

Cas Number:

76169-45-4

Molecular formula:

C14H26O

IUPAC Name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, cis-

impurity 3

Reference substance name:

1-methyl-4-(4-methylpentylidene)cyclohexanecarbaldehyde

Molecular formula:

C14H24O

IUPAC Name:

1-methyl-4-(4-methylpentylidene)cyclohexanecarbaldehyde

impurity 4

Reference substance name:

1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

EC Number:

257-942-2

EC Name:

1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

Cas Number:

52475-86-2

Molecular formula:

C14H22O

IUPAC Name:

1-Methyl-4-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbaldehyde

impurity 5

Reference substance name:

1-methyl-3-(4-methylpentylidene)cyclohexanecarbaldehyde

Molecular formula:

C12H24O

IUPAC Name:

1-methyl-3-(4-methylpentylidene)cyclohexanecarbaldehyde

Specific details on test material used for the study:

- Name of test material (as cited in study report): 77-449, Vernaldehyde

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

No data

Duration of exposure:

No data

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 (in total)

Control animals:

not required

Details on study design:

No data

Statistics:

None.

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: None observed.

Gross pathology:

The following observations were observed:
Dark liver (3 animals), liver mottled (1 animal), pale kidney (1 animal) and exudate anogenital (1 animal).

Other findings:

All 10 animals showed severe redness and moderate edema.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study with rabbits, performed equivalent to OECD 402 guideline, an LD50 >5000 mg/kg bw was determined.

Executive summary:

Vernaldehyde was tested in an acute dermal toxicity study with rabbits, performed equivalent to OECD 402 guideline. No deaths occurred. The following necropsy observations were observed: Dark liver, liver mottled, pale kidney and exudate anogenital. All animals showed severe redness and moderate edema. Based on the results, an LD50 >5000 mg/kg bodyweight was determined.