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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March, 1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study meets the EC Standards (conducted equivalent to OECD 405). Non GLP. Deviations: lack of study design details in the report, no details on test material, no details on test animals and environmental conditions and the observation period was limited to 7 days. Only a very short description is reported. The main parameters, amount of substance, number of animals, scoring times and scoring system are reliable and thus the result is considered reliable with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

lack of study design details in the report, no details on test material, no details on test animals and environmental conditions and the observation period was limited to 7 days

Principles of method if other than guideline:

The method of procedure is that suggested by Dr. Draize and described in 'Appraisal of the Saftey of Chemicals in Foods, Drugs and Cosmetics', published by the Association of Food and Drug Officials of the United States.

GLP compliance:

no

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:

Vernaldehyde
- Name of test material (as cited in study report): #7155

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

Three normal, healthy, albino rabbits were used in the experiment.

Test system

Vehicle:

other: alcoholic propylene glycol

Controls:

other: the left eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 2% in 80% alcoholic propylene glycol (by weight)

Duration of treatment / exposure:

Single instillation on Day 1.

Observation period (in vivo):

The eyes of each animal were examined approximately 24, 48, 72 and 96 hours and 7 days after instillation of the test substance

Number of animals or in vitro replicates:

3

Details on study design:

STUDY DESIGN
No data

TREATMENT
Each animal had 0.1 mL of the diluted test sample instilled into the right eye with no further treatemt.

REMOVAL OF TEST SUBSTANCE
Washing: No

OBSERVATIONS
The scorings recorded were made according to the Draize scale for scoring ocular lesions (according to OECD).

The scorings were made according to the Draize scale for scoring ocular lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No irritation was observed in the treated eyes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute eye irritation/corrosion study with albino rabbits, performed equivalent to OECD 405 test guideline, no irritation was observed with the diluted substance.

Executive summary:

The diluted test substance (2% in 80% alcoholic propylene glycol) was tested in an acute eye irritation/corrosion study in 3 albino rabbits, performed equivalent to OECD 405 test guideline. No irritation was observed.

Based on the results, the diluted test substance does not have to be classified for eye irritation. No conclusions can be drawn on the 100% test substance.