Dodecanal

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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, 2-methylundecanal. 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 (2-methylundecanal) and their similar physico-chemical properties.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

4 rabbits were dermally exposed to the test material for 24 hr and then observed for 10 days. The study was repeated with 3 new rabbits with an observation period of 14 days.

GLP compliance:

no

Remarks:

Study predates GLP

Test material

Test material information

Constituent 1

Reference substance name:

2-methylundecanal

EC Number:

203-765-0

EC Name:

2-methylundecanal

Cas Number:

110-41-8

IUPAC Name:

2-methylundecanal

Constituent 2

Reference substance name:

Aldehyde C12 MNA

IUPAC Name:

Aldehyde C12 MNA

Details on test material:

- Names of test material: RIFM 71-16, aldehyde C-12 MNA
- Molecular formula: C₁₂H₂₄O
- Molecular weight: 529.116
- Smiles notation: O=CC(CCCCCCCCC)C
- InChl: InChI=1S/C12H24O/c1-3-4-5-6-7-8-9-10-12(2)11-13/h11-12H,3-10H2,1-2H3
- Structural formula attached as image file.
- Substance type: Clear 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

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.8 to 3.0 kg
- Fasting period before study: No data
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: No data

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

Test system

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 10 mL/kg

Duration of treatment / exposure:

24 hr

Observation period:

10 days (test group 1)
14 days (test group 2)

Number of animals:

2 male, 2 female (test group 1)
2 male, 1 female (test group 2)

Details on study design:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: damming

REMOVAL OF TEST SUBSTANCE
- Washing: With water
- Time after start of exposure: 24 hr

SCORING SYSTEM:
- Not explicitly stated, although scoring can be presumed to be the standard scoring system of Draize (1959), and this matches details given in the text.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

4

Reversibility:

not fully reversible within: 10 d

Remarks on result:

other: 10 day observation period

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

4

Reversibility:

not fully reversible within: 10 d

Remarks on result:

other: 10 day observation period

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Reversibility:

not fully reversible within: 10 d

Remarks on result:

other: 10 day observation period

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

3

Reversibility:

not fully reversible within: 10 d

Remarks on result:

other: 10 day observation period

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

4

Reversibility:

not fully reversible within: 10 d

Remarks on result:

other: 10 day observation period. Oedema was replaced by a shell of hard peeling skin by day 7.

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

4

Reversibility:

not fully reversible within: 10 d

Remarks on result:

other: 10 day observation period. Oedema was replaced by a shell of hard peeling skin by day 7

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

0

Remarks on result:

other: 10 day observation period

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 10 day observation period

Results 9

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Reversibility:

not fully reversible within: 14 d

Remarks on result:

other: 14 day observation period

Results 10

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

4

Reversibility:

not fully reversible within: 14 d

Remarks on result:

other: 14 day observation period

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Reversibility:

not fully reversible within: 14 d

Remarks on result:

other: 14 day observation period

Results 12

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

0

Remarks on result:

other: 14 day observation period

Results 13

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

3

Reversibility:

fully reversible within: 6 d

Remarks on result:

other: 14 day observation period. Oedema was replaced by a shell of hard peeling skin by day 6.

Results 14

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

0

Remarks on result:

other: 14 day observation period

Results 15

Irritation parameter:

erythema score

Basis:

mean

Remarks:

All animals

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

3.25

Remarks on result:

other: 10 day observation period

Results 16

Irritation parameter:

edema score

Basis:

mean

Remarks:

All animals

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2.25

Remarks on result:

other: Observation period 10 days

Any other information on results incl. tables

For full details on results, see the attached supporting material.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was assessed for skin irritation using rabbits. In accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008 the results obtained determine that the test material 2-methylundecanal should be classified as a Category 2 skin irritant.
A valid study is available for the analogue substance, 2-methylundecanal. 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 (2-methylundecanal) and their similar physico-chemical properties.