Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Remarks:

intraperitoneal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1978-1979

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 Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: estimate of the potential acute hazard after a single administration (determination of the LD50)
- Short description of test conditions: intraperitoneal administration of a solution (test substance dissolved in aqua dest.)
- Parameters analysed / observed: LD50, Clinical Signs, Necropsy Findings, Pathology, Mortality, Mean Weight

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione

EC Number:

226-408-0

EC Name:

Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione

Cas Number:

5395-50-6

Molecular formula:

C8H14N4O6

IUPAC Name:

1,3,4,6-tetrakis(hydroxymethyl)-octahydro-[1,3]diazolo[4,5-d]imidazole-2,5-dione

Test material form:

liquid

Specific details on test material used for the study:

preparation with aqua dest., administered as solution

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga
- Weight at study initiation: male animals 24 - 28 g, female animals 22 - 24 g
- Fasting period before study: 15 - 20 h before administration
- Diet (e.g. ad libitum): Herilan MRH-Haltung; Eggersmann KG

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Details on exposure:

administered volume: 10 mL/kg body weight

Doses:

2000 mg/kg, 700 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:
mortality: 1 h, 1 d, 2 d, 7 d, 14 d
mean weight: beginning of test, 2 - 4 d, 7 d, 13 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy findings, pathology, mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 2/10 dead animals

Mortality:

2 dead male animals 14 d after administration of 2000 mg/kg. 20 % mortality in high dose level

Clinical signs:

staggering (2000 mg/kg)
spastic gait, piloerection, dyspnea, apathy, poor general state (700 and 2000 mg/kg)

Body weight:

no effects observed

Gross pathology:

sacrificed animals: Cadaverous; no intraabdominal precipitates of the test substance or adhesions

Any other information on results incl. tables

Table 1: LD50 determination

Doses [mg/kg]	No. of animals	Dead animals after 14 days	Mortality [%]	Doses used for calculating LD50
700	10	0	0
2.000	10	2	20.0	*

Table 2: Mean weight

Dose [mg/kg]		2.000	700
Male animals	Mean weight [g]
	Beginning of test	28	24
	After 2 – 4 d	24,2	29,2
	After 7 d	24,8	30,8
	After 13 d	25,8	31,8
Female animals	Beginning of test	24	22
	After 2 – 4 d	23,8	25,8
	After 7 d	25,6	26,0
	After 13 d	27,6	26,2

Applicant's summary and conclusion

Conclusions:

After intraperitoneal injection, the LD50 for the test substance is > 2.000 mg/kg body weight.