Dodecanal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

A valid study is available for the analogue substance, Undec-10-enal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (Dodecanal) and source substance (Undec-10-enal) and their similar physico-chemical properties.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize test as described in "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics", Association of Food and Drug Officials of the United States

Deviations:

not specified

Principles of method if other than guideline:

Ocular Draize test.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enal

EC Number:

203-973-1

EC Name:

Undec-10-enal

Cas Number:

112-45-8

IUPAC Name:

undec-10-enal

Constituent 2

Reference substance name:

TC1466A

IUPAC Name:

TC1466A

Details on test material:

- Name of test material (as cited in study report): One sample liquid labelled TC1466 A 2/13/64
- Molecular formula (if other than submission substance): C₁₁H₂₀O
- Molecular weight (if other than submission substance): 168.275894
- Smiles notation (if other than submission substance): C=CCCCCCCCCC=O
- InChl (if other than submission substance): InChI=1S/C11H20O/c1-2-3-4-5-6-7-8-9-10-11-12/h2,11H,1,3-10H2
- Structural formula attached as image file.
- Substance type: Liquid
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino, not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Volume applied: 0.1 mL

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

7 d (observations at 1 d, 2d, 3 d, 4 d, 7 d)

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Not performed

SCORING SYSTEM:
- Draize scale.
- The scoring system is explained fully in the attached supporting information for the results section.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

2.667

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: Contributing to positive classification as category 2 eye irritant.

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: Contributing to positive classification as category 2 eye irritant.

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

1.667

Max. score:

3

Reversibility:

fully reversible within: 4 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

2.333

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

1.667

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: Mean of scores at 24 hrs, 48 hrs, 72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 d

Irritant / corrosive response data:

For full results please refer to the attached supporting information.

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was used to assess eye irritation using albino rabbits. Under the conditions of the test the test substance was found to be irritating to eyes.

A valid study is available for the analogue substance, Undec-10-enal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (Dodecanal) and source substance (Undec-10-enal) and their similar physico-chemical properties.