Propane-1,2,3-triyl trisheptanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01-12 Mar and 21 Jun-06 Jul 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2,3-triyl trisheptanoate

EC Number:

210-647-2

EC Name:

Propane-1,2,3-triyl trisheptanoate

Cas Number:

620-67-7

Molecular formula:

C24H44O6

IUPAC Name:

1,3-bis(heptanoyloxy)propan-2-yl heptanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Chemical name: Heptanoic acid triglyceride
- Physical state: pale yellow liquid
- Analytical purity: 97.2%
- Date of production: September 29th, 1992
- Batch No.: 209052
- Expiration date of the lot/batch: October 1993 at the earliest
- Homogeneity: liquid appeared homogeneous on inspection
- Density (20 °C): 0.96 g/cm³
- Stability under test conditions: > 1 year
- Storage condition of test material: in a closed glass vessel ina laboratory hood
- Solubility (20°C): not soluble in water

Test animals

Species:

rabbit

Strain:

other: Small White Russian, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: adult animals
- Weight at study initiation: 2-3 kg
- Housing: conventionally, singly in stainless steel cages
- Diet: Ssniff K 4 - Complete feed for rabbits (Ssniff, Spezial futter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 14 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 days (2 animals)
10 days (4 animals)
Reading time points: 30-60 min, 24, 48 and 72 h, 6, 8, 10 and 14 days

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on the dorsal area
- Type of wrap if used: the treated skin was covered with a gauze patch and a non-irritant plaster, held in place using a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: the area of application was cleaned with warm water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

2.22

Max. score:

4

Reversibility:

fully reversible within: 6-14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

1.94

Max. score:

4

Reversibility:

fully reversible within: 6-14 days

Irritant / corrosive response data:

After an exposure time of 4 h, and 30-60 min after patch removal, well-defined erythema and very slight to well-defined edema were observed in all animals. One animal showed moderate to severe erythema and severe edema with brown discolouration and dryness of the skin after 24-72 h. Sanguineous lacerations and scaling were also observed on the skin. At these time points, 4 animals showed no increase in the severity of the described signs of irritation. Moderate redness of the skin was observed in one animal after 72 h. After 72 h, this animal also showed dry skin and severe extensive subcutaneous haemorrhage. After 6 days, scaling was observed in all animals, and after 10 to 14 days, all animals were free of abnormalities.

Other effects:

No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Summary of results.

 

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythemy	Edema	Erythema	Edema	Erythema	Edema
0.5-1 h	2	1	2	1	2	1	2	2	2	2	2	1
24 h	2	1	2	2	2	1	3	4	2	2	2	2
48 h	2	1	2	2	2	2*	3	4	2*	1*	2	2
72 h	2	1	2	2	2	1	3	4	2*	1*	3	2
6 days	0	0	1	0	0	0	2	2	0	0	1	1
8 days	0	0	1	0	0	0	1	1	0	0	1	1
10 days	0	0	0	0	0	0	1	1	0	0	1	1
14 days	nd	nd	nd	nd	nd	nd	0	0	nd	nd	0	0
Mean value 24 +48 + 72 h	2.00	1.00	2.00	2.00	2.00	1.33	3.00	4.00	2.00	1.33	2.33	2.00
Observations (reading time point)
Skin discolouration
Brownish							72 h
Skin surface
Dry							48-72 h				72 h
Sanguineous lacerations							72 h
Scaling	6-8 days		6-8 days		6-8 days		72 h-10 days		6 days*		6-8 days
Detachment	6-8 days		8 days		8 days		6-10 days				6-8 days
Severe extensive subcutaneous haemorrhage											72 h

 

* local skin reaction

nd: not determined

Applicant's summary and conclusion

Interpretation of results:

other: not irritating according to CLP; irritating according to DSD

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: Xi, R38