Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: ENTER THE HYPOTESIS FOR THE ANALOGUE APPROACH Meest generally accepted scientific standards, well documented and acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
Estimate of the potential acute hazard after a single intraperitoneal administration of the test material in rats (determination of the LD50).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fastusol-Rot 43 L (flüssig)
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River WIGA, Sulzfeld, FRG
- Age at study initiation: about 12 weeks
- Weight at study initiation: mean males: 200 g; mean females: 180 g
- Fasting period before study: 16 hours
- Housing: in groups of 5 in Type DK-III stainless steel wire mesh cages (supplied by Becker & Co., Castrop-Rauxel, FRG)
- Diet: SSNIFF R (Ssniff Versuchstierdiäten, Soest, FRG) ad libitum
- Water: Fully demineralized water each workday, ad libitum; tap water on public holidays, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
Single injection into the abdominal cavity. Form of administration: Solution
Doses:
56.2; 82.5; 147.0; 215.0 mg/kg
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: Check for moribund and dead animais twice each workday and once daily at weekends and on public holidays. Recording of signs and symptoms < 15', 15', 30', 1 h, 2 h, 4 h, and 5 h after administration of test substance and then once each workday. Weighing of groups before administration, 2nd weighing 2 d, 3rd weighing 4 d, 4th weighing 7 d and 5th weighing 13 d after administration.
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
115 mg/kg bw
Based on:
test mat.
95% CL:
93 - 142
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 147 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
100 mg/kg bw
Based on:
test mat.
95% CL:
70 - 145
Mortality:
See table below.
Clinical signs:
Clinical signs included dyspnea, apathy, staggering, atonia, trembling, spastic gait, orange/red skin, orange/yellow urine, piloerection, alopecia, exsiccosis, cachexia, ptosis, blood in the urine and poor general state.
Body weight:
See table below.
Gross pathology:
Animals that died:
147 mg/kg, 82.5 mg/kg: Muscles and adipose tissue: colored by the test substance.
215 mg/kg: Stomach: bloody ulcerations in the glandular stomach; muscles, adipose tissue and subcutis: colored by the test substance.

Sacrificed animals:
56.2 mg/kg, 82.5 mg/kg, 147 mg/kg: Muscles, cartilage and adipose tissue: tinge of the test substance; organs: slightly colored by the test substance.
215 mg/kg: Abdominal organs, cartilage, muscles and adipose tissue: colored by the test substance.

Any other information on results incl. tables

Acute intraperitoneal toxicity:

Dose (mg/kg)

215.0

147.0

82.5

56.2

Mortality

M: Number of animals

5

5

5

5

Dead animals after:

1 h

0

0

0

0

1 d

0

0

0

0

2 d

0

0

0

0

7 d

5

3

0

0

14 d

5

3

0

0

 

F: Number of animals

5

5

5

5

Dead animals after:

1 h

0

0

0

0

1 d

0

0

0

0

2 d

0

0

0

0

7 d

5

4

1

0

14 d

5

4

2

0

 

Mean weight (g)

M: Beginning of test:

210

190

200

200

After

2 d

 

177

203

208

 

4 d

186

 

 

 

 

7 d

 

164

254

269

 

13 d

 

241

302

311

F: Beginning of test:

170

190

180

180

After

2 d

 

183

175

180

 

4 d

149

 

 

 

 

7 d

 

152

178

210

 

13 d

 

207

211

218

M = male; F = female; d = day; h = hour

Applicant's summary and conclusion

Conclusions:
The LD50 after single injection into the abdominal cavity of male and female rats was determined to be 115 mg/kg bw.
Executive summary:

Estimate of the potential acute hazard after a single intraperitoneal administration of the test material in rats (determination of the LD50). The LD50 after single injection into the abdominal cavity of male and female rats was determined to be 115 mg/kg bw.