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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 089 mg/kg bw
Based on:
test mat.
95% CL:
>= 934 - <= 1 296
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.