1,2,3-Propanetriol, homopolymer, docosanoate

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 guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Polyglycerintribehenat

IUPAC Name:

Polyglycerintribehenat

Details on test material:

- Name of test substance: Polyglycerintribehenat
- Batch number: Partie 29
- Degree of purity/content: 85.8% behenic acid bound as behenic ester, 13.0% polyglycerin
- Date of manufacture: 02-Feb-1996
- Physical state/appearance: solid (congealed melt), beige at room temperature; liquid, beige at about 85 °C
- Storage conditions: room temperature
- Stability and homogeneity: The stability of the test substance over the study period has been proven by reanalysis. After heating at about 85°C the test substance was homogeneous by visual inspection.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 3.65, 3.90, and 3.91 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: about 130 g per animal per day Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: the test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL of the at about 85°C heated test substance. Before application it was cooled down to body temperature.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (1 female, 2 males)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on upper third of the back or flanks
- Type of wrap if used: the test substance has been covered with the test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern, FRG) and Fixomull stretch (adhesive fleece; Baiersdorf AG, FRG)

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema. The skin finding observed in 1 animal was reversible 24 hours after removal of the patch.

Any other information on results incl. tables

Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means (24, 48, 72 hours):

Readings	Animal	Erythema	Edema
1 h	01	0	0
	02	1	0
	03	0	0
24 h	01	0	0
	02	0	0
	03	0	0
48 h	01	0	0
	02	0	0
	03	0	0
72 h	01	0	0
	02	0	0
	03	0	0
Mean	01	0.0	0.0
	02	0.0	0.0
	03	0.0	0.0
Mean		0.0	0.0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the test conditions chosen the test material did not give indication of an irritant property to the skin.

Executive summary:

The potential of the test material to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white New Zealand rabbits for 4 hours under semiocclusive dressing.

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema. The skin finding observed in 1 animal was reversible 24 hours after removal of the patch. Thus the study was terminated after 72 hours.

Conclusion: Under the test conditions chosen the test material did not give indication of an irritant property to the skin.