Diguanidinium carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: - meets generally accepted scientific principles - sufficient information for assessment reported

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

post exposure period only 7 d

GLP compliance:

no

Remarks:

study predates implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diguanidinium carbonate

EC Number:

209-813-7

EC Name:

Diguanidinium carbonate

Cas Number:

593-85-1

Molecular formula:

CH5N3.1/2CH2O3 (one guanidine species, as denoted in the ESIS database) CH5N3.CH5N3.CH2O3 (as in the crystalline from, basis for the molecular weight 180.1658 g/mol as given below)

IUPAC Name:

bis(amino(imino)methanaminium) carbonate

Details on test material:

- Name of test material (as cited in study report): Guanidinkarbonat
- Physical state: not reported, but assumed to be a solid powder
- Analytical purity: 99.4 %
- Impurities (identity and concentrations):
• Melamin: 0.1 %
• Urea: 0.34 %
• Fe: 25 ppm
- Lot/batch No.: not reported
- Stability under test conditions: not reported, but assumed to be stable
- Storage condition of test material: not reported
- Number of certificate of analysis: BPH/Wö/A1 of 1978-01-05

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding facility
- Age at study initiation: not reported
- Weight at study initiation: 150 - 200 g
- Fasting period before study: 2 - 3 hours prior to oral application until 2 - 3 hours after application, food was removed. Water was given immediately after application.
- Housing: 5 per cage, Makrolon R cage
- Diet (e.g. ad libitum): ALTROMIN R-R-pellets, ad libitum
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported, but raised in own breeding facility

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 26 ± 1
- Humidity (%): 50 - 60
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

test substance applied as 13.3 % aqueous solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 13.3 %
- Amount of vehicle (if gavage): 4.45, 6.7, 10, 15 ml/kg bw
- Justification for choice of vehicle: The test item was known to be sufficiently water soluble

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg

Doses:

592, 889, 1333 and 2000 mg/kg bw,

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 d
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: not reported
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: not reported

Statistics:

Thompson-Weil (Thompson WRT and Weil CS, 1952, Biometrics 8:51-4; Weil CS, 1952, Biometrics 8:249-63).
Tables from this article were supplemented with r-values by the company's data processing centre.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 089 mg/kg bw

Based on:

test mat.

95% CL:

>= 934 - <= 1 296

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 045 mg/kg bw

Based on:

test mat.

95% CL:

>= 914 - <= 1 197

Mortality:

see table 1 for details

Clinical signs:

other: not reported

Gross pathology:

not reported

Any other information on results incl. tables

- Table 1: Mortality in Sprague-Dawley rats

Dose in mg/kg bw	fatalities within 7 d post dosing
	females	males
592	0/10	0/10
889	2/10	1/10
1333	9/10	10/10
2000	10/10	10/10
LD50 in mg/kg bw	1045	1089
95 % confidence limits	(914 - 1197)	(934 - 1269)

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Guanidine carbonate was tested for its acute oral toxicity in Sprague-Dawley rats of both sexes after single oral treatment following a procedure generally equivalent to OECD TG 401. Doses used were 592, 889, 1333 and 2000 mg/kg bw. Post exposure observation period was 7 d.
The LD50 values for males and females are 1089 mg/kg bw (95 % CL: 934 – 1296) and 1045 mg/kg bw (95 % CL: 914 – 1197) respectively.

Executive summary:

Guanidine carbonate was tested for its acute oral toxicity in Sprague-Dawley rats of both sexes after single oral treatment following a procedure generally equivalent to OECD TG 401. Doses used were 592, 889, 1333 and 2000 mg/kg bw. Post exposure observation period was 7 d.

LD50 values were determined by the method of Thompson-Weil.

The LD 50 values for males and females are 1089 mg/kg bw (95 % CL: 934 – 1296 mg/kg bw) and 1045 mg/kg bw (95 % CL: 914 – 1197 mg/kg bw), respectively.