Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(adopted 1987)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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): 2,2`-Oxybisethanol, ethoxylated and propoxylated (>1< 4.5 mol EO and >1< 4.5 mol PO)
-Test item number: 11/0042-1
- Physical state: Liquid, colorless, clear
- Analytical purity: >99%
- Lot/batch No.: T35/034/10
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Test animals: Wistar rats (Crl:WI (Han) SPF)
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Housing: single housing in Makrolon cages (Type III)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: about 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze and stretch bandage (Fixomull® Stretch (adhesive fleece))

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 5000 mg/kg bw (4.62 mL/kg bw)
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs was performed several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: A check for any dead or moribund animals was made at least once each workday. Individual skin readings were performed 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination. No local effects were observed.
Body weight:
The mean body weight of the male and most female animals increased throughout the study period within the normal range. The mean body weight of two female animals stagnated during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals after sacrifice at the end of the observation period.
Other findings:
No other findings were observed.

Any other information on results incl. tables

Table 1: Individual body weight changes of male Wistar rats.

Individual body weight changes

Dose

5000

Sex

male

Animal number

R479

R480

R481

R482

R483

Mean weight

Standard deviation

Body weight at study day (g):

 

 

 

 

 

 

 

0

233

232

233

240

241

235.8

4.32

7

264

255

252

266

277

262.8

9.88

14

300

285

283

299

314

296.2

12.64

 

Table 2:Individual body weight changes of female Wistar rats.

Individual body weight changes

Dose

5000

Sex

female

Animal number

R484

R485

R486

R487

R488

Mean weight

Standard deviation

Body weight at study day (g):

 

 

 

 

 

 

 

0

199

213

207

212

208

207.8

5.54

7

196

222

214

215

217

212.8

9.88

14

200

233

222

234

231

224.0

14.23

 

 

Applicant's summary and conclusion