isostearic acid monoisopropanolamide

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-540-9

EC Name:

-

Cas Number:

170573-32-7

Molecular formula:

C21H43NO2

IUPAC Name:

N-(2-hydroxypropyl)-2,2,5,8,11,11-hexamethyldodecanamide

Test material form:

liquid: viscous

Specific details on test material used for the study:

Batch no.: DM5/282
Appearance: amber cloudy liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: "l'elevage Cunicole de Val de Seile, 80160 Prouzel, France"
Acclimation: at least 5 days
Weight: 2.4 +/- 0.2 kg
Temperature: 20 +/- 3°C
Relative humidity: 50 +/- 20%
Light period: 12h light / 12h dark
Feed: "Lapins entretien reference 112 C" (U.A.R., 91360 Villemoisson-Sur-Orge, France), ad libitum
Water: filtered tap water, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

6 cm2

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

At 1, 24, 48 and 72h and daily thereafter (for 9 days)

Number of animals:

3 (males)

Details on study design:

Skin reactions (erythema and oedema) were evaluated using the Draize scoring (and every other symptoms was recorded as well).
They were measured after 24, 48 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Important skin reactions were observed during at least 48 hours in the 3 rabbits. They worsened for 3 days thereafter (until Day 5) with the development of an erythema. No oedema was observed. From Day 5, the erythema decreased and disappeared on Day 8. The skin remained dry until Day 8. As 2 animals out of 3 presented an erythema of 2.0 and the reactions were reversible within 8 days, the test substance was not considered irritant to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was not considered to be irritant to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the test substance according to EU Method B.4, in compliance with GLP. Three male rabbits (New-Zealand White) were exposed for 4 h to 0.5 mL undiluted test substance, under a semiocclusive bandage. The left flank remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h and daily thereafter (for 9 d). Skin reactions (erythema and oedema) were evaluated using the Draize scoring and measured after 24, 48 and 72 h. The skin reactions were present until Day 5 with the development of erythema. No oedema was observed. From Day 5, the erythema decreased and disappeared on Day 8. The skin remained dry until Day 8. Under the study conditions, the test substance was not considered to be irritating to rabbit skin (Clouzeau, 1992).