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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
Study period:
1976-01-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for assessment but without detailed documentation. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
No further information available.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dicyanoamide
EC Number:
217-703-5
EC Name:
Sodium dicyanoamide
Cas Number:
1934-75-4
Molecular formula:
C2HN3.Na
IUPAC Name:
sodium dicyanamide
Test material form:
solid

Test animals

Species:
rat
Strain:
not specified
Remarks:
albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Age at study initiation: young adult rats
- Weight at study initiation: 200-300 grams
- Fasting period before study: yes, fasted for twenty-four hours
- Housing: common cage
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
250 mg/kg
500 mg/kg
630 mg/kg
800 mg/kg
1000 mg/kg
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female were used for each dose level.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no

Results and discussion

Preliminary study:
not reported
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 725 mg/kg bw
Based on:
test mat.
95% CL:
>= 605 - <= 875
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 775 mg/kg bw
Based on:
test mat.
95% CL:
>= 670 - <= 895
Sex:
male
Dose descriptor:
LD0
Effect level:
ca. 250 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
ca. 500 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD100
Effect level:
ca. 1 000 mg/kg bw
Mortality:
Please see table 1 in section "any other information on results incl. tables".
Clinical signs:
Please refer to section "any other information on results incl. tables".
Body weight:
not examined
Gross pathology:
not performed
Other findings:
none reported

Any other information on results incl. tables

Table 1: Experimental data:

Dose level mg/ kg bw

No. of male rats

Survivors

Deaths

Day of deaths

250

5

5

0

-

500

5

4

1

1

630

5

4

1

1

800

5

2

3

1

1000

5

0

5

1

2000

5

0

5

1

Dose level mg/ kg bw

No. of female rats

Survivors

Deaths

Day of deaths

250

5

5

0

-

500

5

5

0

-

630

5

4

1

2

800

5

3

2

1

1000

5

0

5

1

2000

5

0

5

1

Observations:

Males: At 250 mg/kg, the animals were languid with nasal haemorrhage and ruffled, unkempt coats. The animals dosed at 500, 630, 800 and 1000 mg/kg were lethargic with very ruffled, unkempt coats. Within one hour, all animals were crouched in a fetal position. At this time, ocular and nasal haemorrhage were first evident. Convulsions began about 2-2.5 hours after intubation. Survivors remained unkempt throughout the observation period. Symptoms of toxicity at 2000 mg/kg were the same as at 1000 mg/kg except for their severity. All animals succumbed within 2 hours.

Females: Nasal haemorrhage, sluggish locomotion and ruffled, unkempt coats were noted at 250 mg/kg. At dosage level of 500 mg/kg, 630 mg/kg and 800 mg/kg, the animals were lethargic with ruffled, unkempt coats. Spasmodic movements were noted. Within an hour, all animals were in a fetal position. Lacrimation, ocular and nasal haemorrhage were noted. Convulsions began approximately two hours after dosing. The animals dosed at 1000 mg/kg and 2000 mg/kg showed the same toxicity as at 800 mg/kg. All animals died within 2 -4 hours after incubation.

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 value of the test item is 725 mg/kg (male albino rats). Therefore, the test item will be classified as acute toxic; category 4; oral, H302.
Executive summary:

In an acute oral toxicity, groups of fasted male and female albino rats were given a single oral dose of sodium dicyanoamide in propylene glycol at doses of 250, 500, 630, 800, 1000 and 2000 mg/kg bw. The animals were observed daily for a two-week period.

The oral LD50 in males was 725 mg/kg bw (95% CL: 605 -875 mg/kg bw) and 775.0 mg/kg bw in females (95% CL: 670.0 - 895.0 mg/kg bw).

All animals died at a dose of 1000 mg/kg bw and higher. At lower doses, symptoms like unkempt coats, lethargy, convulsions and haemorrhage were observed.

The LD50 value of the test item is 725 mg/kg bw in male albino rats, therefore the test item will be classified as acute toxic; category 4; oral, H302 according to GHS/CLP classification criteria.

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