Dodecanamide, N,N-dibutyl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

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:

N,N-dibutyl-lauroyl amide

IUPAC Name:

N,N-dibutyl-lauroyl amide

Constituent 2

Reference substance name:

DIBULAM

IUPAC Name:

DIBULAM

Details on test material:

- Name of test material (as cited in study report): N,N-dibutyl-lauroyl amide (DIBULAM) - Supplier: Osaka Research Laboratories, Sanko Chemical Co., Ltd
- Physical state: liquid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 00804
- Stability under test conditions: stable in ambient conditions
- Storage condition of test material: cool and dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama Labes Co., Ltd., 28, Nishikyougoku Katsuno-machi, Ukyo-ku Kyoto, 615, Japan
- Age at study initiation: 4 months
- Weight at study initiation: 3.25-3.62 kg
- Housing: individually in aluminium cages 350 x 480 x 330 mm
- Diet (e.g. ad libitum): pelleted RC4 diet (Oriental Yeast Co., Ltd.) ad libitum
- Water (e.g. ad libitum):Hita city water ad libitum
- Acclimation period: 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2°C
- Humidity (%): 55±15%
- Air changes (per hr): 10-15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 25 September 1990 To: 9 October 1990

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mg

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6

Details on study design:

TEST SITE
- Number of application sites per animal: 2
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not reported
- Type of wrap if used: lint (2.5 x 2.5 cm) fastened to application site with surgical tape and covered in oil paper. Secured by winding elastic bandage around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed from the application sites but no further details reported
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to criteria in OECD test guideline 404 (1981) GRADING SYSTEM: according to the AFNOR scale (1982). The primary cutaneous irritation index (PCII) was calculated by dividing the total score of erythema, eschar formation and oedema by the total number of application sites at the 1, 24, 48 and 72 hour readings after patch removal.

Results and discussion

In vivo

Results

Irritation parameter:

other: PCI

Basis:

mean

Time point:

other: 1, 24, 48 72 hours

Score:

4.7

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: no erythema or oedema persisted but eschar formation or desquamation still persisting at 4/12 application sites 7-14 days after patch removal

Irritant / corrosive response data:

Well defined erythema and very slight oedema observed at all application sites at the 1 hour reading. Severe erythema or erythema with eschar formation was present at the 24-72 hour readings. All erythema and oedema had cleared at the 14 day reading but 4/12 application sites still had eschar formation or desquamation 7-12 days after patch removal.

Other effects:

None

Any other information on results incl. tables

Table: Individual and mean skin irritation scores of N,N-dibutyl-lauroyl amide - See attched report (page 9)

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

N,N-dibutyl-lauroyl amide is irritant to the skin

Executive summary:

Six rabbits (2 application sites/rabbit) were treated with a 4 hour application of N,N-dibutyl-lauroyl amide and skin irritation assessed.

The PCI was calculated to be 4.7 and N,N-dibutyl-lauroyl amide was classified as moderately irritant according to the AFNOR (1982) sacle.