Isooctadecanoic acid, monoester with propane-1,2-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Jun to 08 Aug 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

yes

Remarks:

purity not reported; assessed 24, 48 and 72h after application, not after patch removal

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

Limited documentation details, no rationale for in vivo testing

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: 67/548/CEE

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Isooctadecanoic acid, monoester with propane-1,2-diol

EC Number:

269-027-5

EC Name:

Isooctadecanoic acid, monoester with propane-1,2-diol

Cas Number:

68171-38-0

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

2-hydroxypropyl 15-methylheptadecanoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage des Feuilletas
- Age at study initiation: not given
- Weight at study initiation: 2 +/- 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm), grid floor
- Diet: rabbit feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5
- Humidity (%): 55 +/- 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 27 Jun to 03 Jul 1989

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

with a fine comb electric clipper to obtain a skin area of approx. 14 x 14 cm

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral side was applied with distilled water as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4h

Observation period:

7 days
Readings at 24h, 48h, 72h, 6d, and 7d after application and at 1h after removal of dressing

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm² square
- Type of wrap if used: Test substance (or water on contralateral body side) was applied on a Codex hydrophilic eight layer gauze, about 2.5 cm², which was laid down on the skin. The gauze was kept in contact with skin using a hypoallergenic microporous adhesive strip. The whole was then covered with a stretchable band (fixed with adhesive tape) wrapped round the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

OBSERVATION TIME POINTS
1 hour after removal of dressing; 24 hours, 48 hours, 72 hours, 6 days, and 7 days after application

SCORING SYSTEM:
- Method of calculation: erythema and edema scores from 0-4.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Three animals were tested.
The individual mean erythema scores over 24/48/72 hours were 0.66, 0.66, and 1.0.
The individual mean oedema scores over 24/48/72 hours were 0.33, 0.0, and 0.0.

Any other information on results incl. tables

Erythema Draize scores, 4h semi-occlusive, 0.5 mL unchanged test substance, NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	1	1	0	0	0
2	1	1	0	0	0
3	1	1	1	0	0

Oedema Draize scores, 4h semi-occlusive, 0.5 mL unchanged test substance, NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	0	0	0	0	0
2	1	0	0	0	0
3	0	0	0	0	0

Erythema Draize scores, 4h semi-occlusive, 0.5 mL aqua dest., NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0

Oedema Draize scores, 4h semi-occlusive, 0.5 mL aqua dest., NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.