Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
03 - 18 Sep 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. Tested with the source substance Glycerol tristearate. According to the ECHA guidance document 'Practical guide 6: How to report read-across and categories (ECHA, 2102)', 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted in 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
The male rats achieved satisfactory body weight gains throughout the study.
Four female rats showed minimal body weight gain after the first week. One female showed little body weight loss after the first week. At the end of the study, minimal body weight gain was recorded in two female animals and one animal showed no body weight gain. Two female rats achieved satisfactory body weight gains throughout the study. Variation of body weight in this age / body weight range is a physiological finding and not substance-related (see Table 1).
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