Coconut oil, reaction products with polyethylene glycol and trimethylolpropane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1997 - June 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

EC Number:

640-964-5

Cas Number:

218451-68-4

Molecular formula:

not applicable because UVCB

IUPAC Name:

Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): Marlowet 4753
- Physical state: yellowish liquid
- Lot/batch No.: 01/96
- Expiration date of the lot/batch: at least June 1997
- Storage condition of test material: in a sealed glass container in the laboratory fume cupboard

Test animals

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding/Research Centre Ltd., Denmark
- Age at study initiation: adult, no further details mentioned
- Weight at study initiation: 1.8 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-05-26 To: 1997-06-06

Test system

Type of coverage:

semiocclusive

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 cm³

Duration of treatment / exposure:

4 hours

Observation period:

up to 10 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal part of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch was placed, which was covered with non-irritant plaster and held in place with a semi-occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

4.89

Max. score:

8

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 10 d

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 d

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 6 d

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 8 d

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 d

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 2.33
- Edema: 2.56

Other effects:

yellowish discoloration in the application area up to 72 hours, scales on the skin at day 6, detaching at day 8

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score:	Max. score:
60 min	2/2/1	1/2/2
24 h	2/3/2	2/4/2
48 h	2/3/2	2/4/2
72 h	2/3/2	1/4/2
Average 24h, 48h, 72h	2.33	2.56
Reversibility*)	c.	c.
Average time (unit) for reversion	10 days	10 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was determined to be irritating to rabbit skin under the described conditions. The mean values were as follows:
- Erythema: 2.33
- Edema: 2.56

Executive summary:

The acute skin irritant effect on rabbits by Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was tested according to OECD Guidelines for Testing of Chemicals, Section 4, No. 404, "Acute Dermal Irritation/corrosion" OECD 1992.

The test substance was tested on three animals using an exposure time of 4 hours. The liquid test substance (0.5 cm³ in each case) was applied in a single dose to shorn intact skin.

Administration of the test substance led as soon as 24 hours after removing the patches in the case of one of three animals to severe skin irritation in the form of severe erythema and oedema. These symptoms of severe skin irriation were observable up to 72 hours after removing patches and had completely disappeared by the 10th day of the study.

In two animals during this observation period, well-defined erythema and oedema were observed on the skin, with only very slight oedema still being observable on the skin of one animal 72 hours after removing the dressing.

On the 6th day, in one of three animals, well-defined erythema and slight oedema were observed, whereas in two animals only very slight erythema was observed on the skin. These symptoms of skin irritation had completely disappeared on the 10th day for all animals.

24 to 72 hours after removing patches, the skin of one animal had a yellowish discoloration at the point of application, which showed the most severe symptoms of skin irritation. All three animals exhibited scales on the skin on the 6th day, which had completely detached by the 10th day of the study.

The mean values were calculated from the numerically scored individual findings of observations made 24, 48 and 72 hours after the end of the exposure time:

-Erythema and eschar formation: 2.33

-Oedema formation: 2.56

Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was judged to be irritating to rabbit skin under the conditions of this study.