Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Aug. - 03 Sep. 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24.2.1987
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): wash oil
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: WAF (water accommodated fraction) limited
- Storage condition of test material: room temperature, exclusion of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TOP VELAZ s.r.o., Koleč subsidiary
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: males: 193 g (range: 170 - 208 g) / females: 157 g (range: 150 - 165 g)
- Fasting period before study: ~20 h before treatment
- Housing: conventional, 5 per sex
- Diet: from 30 min post-application
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2x/d (day 1 and 2), then 1x/d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
none
Clinical signs:
Hunched, lateral or prone posture, apathy, inappetence, cyanotic or pale skin and ischemic mucous membranes
recovery within 2 d
Body weight:
normal: + 55 g/14 d (m); +29 g/14 d (f) (see tables below)
Gross pathology:
Changes in the lung, more pronounced in female rats: focal emphysema, point-shaped dark-red foci
(indicating to vascular disorder expressed by ischemia peripheric tissues and organs (see lung) probably following a shock-like response).

Any other information on results incl. tables

Table 1: Male body weights (g) – 2000 mg/kg

Animal No.

Before administration

Day 8

Day 15

Increment

1

203.7

240.9

259.8

56.1

2

186.8

214.9

237.3

50.5

3

195.5

222.8

245.7

50.2

4

170.1

199.8

228.8

58.7

5

207.8

238.6

267.9

60.1

Average

192.8

223.4

247.9

55.1

Table 2: Female body weights (g) – 2000 mg/kg

Animal No.

Before administration

Day 8

Day 15

Increment

1

156.3

173

188.3

27

2

150.4

171

175.3

24.9

3

158.3

172

183.1

24.8

4

164.9

189

205.6

40.7

5

153.2

168

182.9

29.7

Average

156.6

174

187

29.4

Table 3: Pathological examination of the male and female rats – 2000 mg/kg

Animal No.

Autopsy finding

males

females

1

No macroscopic changes

Lungs – dark-red dot-like foci

2

Lungs – emphysematous foci

Lungs – emphysematous foci

3

Lungs – dark-red dot-like foci

Lungs – dark-red dot-like foci

4

No macroscopic changes

Lungs – dark-red dot-like foci

5

No macroscopic changes

Lungs – dark-red dot-like foci

Applicant's summary and conclusion