Nitriles, C12-18

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 404 and in compliance with GLP. Read-across from structural identical substance with an aliphatic chain length of only C12.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecanenitrile

EC Number:

219-440-1

EC Name:

Dodecanenitrile

Cas Number:

2437-25-4

Molecular formula:

C12H23N

IUPAC Name:

lauronitrile

Details on test material:

- Name of test material (as cited in study report): Dodecannitril
- Physical state: yellowish liquid
- Analytical purity: > 99%
- Impurities (identity and concentrations): not stated
- Composition of test material, percentage of components: n.a.
- Isomers composition: n.a.
- Purity test date: 25.04.1988
- Lot/batch No.: GVS 069 436 (Labordestillat)
- Expiration date of the lot/batch: 25.04.1989
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: room temperatur, protected from light
- Other:

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.2 - 3.1 kg
- Housing: fully air-conditioned rooms, individual cages.
- Diet (e.g. ad libitum): ad libitum (Altromin 2123, Altromin GmbH (Lage/Lippe))
- Water (e.g. ad libitum): ad libitum (deionised, chlorinated water)
- Acclimation period:
- min. 7 days
- daily observation during acclimation period



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
0.5mL of the test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skinarea (ca. 25 cm2) and then covered with a semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water


SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2.89

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 4 hour exposure

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 4 hour exposure

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 4 hour exposure

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 4 hour exposure

Results 5

Irritation parameter:

edema score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2.44

Max. score:

4

Reversibility:

fully reversible within: 7 - 14 days

Remarks on result:

other: 4 hour exposure

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 4 hour exposure

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 4 hour exposure

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 4 hour exposure

Irritant / corrosive response data:

The test material proved to be irritating to skin.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance dodecannitrile proved to be irritating to skin and has to be labelled with R38 - irritating to skin.

Executive summary:

In a GLP compliant OECD TG 404 study, 0.5 mL the undiluted test material Dodecannitrile, a yellowish liquid (purity > 99%), was applied semi-occlusively for 4 hours to the shaved skin of three New Zealand White Rabbits. The test substance was applied to a 2.5 cm²gauze patch. Examination of the treated skin was started approx. 30 minutes after patch removal and on days 2, 3 and 4. Additional observations were performed on days 7 and 14. Well-defined up to moderate to severe erythema and slight edema were observed in all three animals. All signs of irritation were fully reversible between day 7 and day 14 post application. Average scores for erythema were 3.0, 3.0 and 2.67 (for 24h, 48h and 72h) in all animals. Scores for oedema were 4.0, 1.7 and 1.7 for the same time points. Based on the study results, the test material Dodecannitrile is considered to be irritating to skin.