Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]

Acute Toxicity: other routes

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Reference 2

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

Test material information

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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

115 mg/kg bw

Based on:

test mat.

95% CL:

93 - 142

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 147 mg/kg bw

Based on:

test mat.

Effect levels 3

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.