1,2,3-propanetriyl trioleate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

03 Sep - 18 Sep 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

adopted in 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol tristearate

EC Number:

209-097-6

EC Name:

Glycerol tristearate

Cas Number:

555-43-1

IUPAC Name:

propane-1,2,3-triyl trioctadecanoate

Details on test material:

- Name of test material (as cited in study report): Glycerol tristearate, [trade name]
- Physical state: white, homogeneous powder
- Analytical purity: 98%
- Purity test date: June 17th, 1996
- Batch No.: 512014
- Date of production: January 29th, 1996
- Stability under test conditions: > 3 years
- Storage condition of test material: in tightly closed containers under exhaust hood, kept dry
- Solubility (20 °C): practically insoluble in water
- Density (20 °C): about 0.95 g/cm³

Test animals

Species:

rat

Strain:

other: Wistar (Hsd/Win:WU/SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 261 - 278 g (males), 202 - 220 g (females)
- Housing: individually housed in Makrolon type III cages on soft wood bedding
- Diet: Ssniff R 10 diet in pellet form (laboratory standard rat diet, Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 x 50 mm on the dorsolumbar region
- % coverage: 10%
- Type of wrap if used: the treated skin was covered with gauze which was held in place with a semiocclusive dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated area of skin was cleaned with corn oil and absorbent paper.
- Time after start of exposure: 24 h

PREPARATION OF DOSING SOLUTION
- Preparation: the powdery substance was suspended in corn oil.
- Amount(s) applied (volume or weight with unit): 5 cm³/kg bw
- Concentration: 40 g/100 cm³

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: rats were checked at least twice daily for mortality. Animals were observed for clinical signs 30 min after dosing and at hourly intervals on Day 0, thereafter daily.
- Frequency of weighing: on Days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: local dermal irritations were recorded daily.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

The macroscopical examination on Day 14 revealed no abnormalities.

Other findings:

After removal of the dressings 24 h post-application until the end of the study, no skin irritations were noticed.

Any other information on results incl. tables

Table 1. Body weight.

Animal No.	Body weight on Day (g)			Body weight gain (g)
	0	7	14	Week 1	% body weight gain	Week 2	% body weight gain
Males
1	278	296	305	18	6.5	9	3.0
2	261	278	305	17	6.5	27	9.7
3	260	278	306	18	6.9	28	10.1
4	272	298	321	26	9.6	23	7.7
5	269	294	313	25	9.3	19	6.5
Females
1	202	209	209	7	3.5	0	0.0
2	212	213	217	1	0.5	4	1.9
3	220	213	223	-7	-3.2	10	4.7
4	220	234	250	14	6.4	16	6.8
5	208	210	215	2	1.0	5	2.4

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified