Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, 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

Constituent 1
Reference substance name:
2 Naphthylamin-(2)-sulfosäure-[(6)-N,N'-Carbonyl-bis-6-aminonaphthol-(1)-sulfonsäure-(3)]
IUPAC Name:
2 Naphthylamin-(2)-sulfosäure-[(6)-N,N'-Carbonyl-bis-6-aminonaphthol-(1)-sulfonsäure-(3)]
Details on test material:
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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.