Sodium dicyanoamide

Acute Toxicity: oral

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

Test material information

Constituent 1

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 levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 725 mg/kg bw

Based on:

test mat.

95% CL:

>= 605 - <= 875

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 775 mg/kg bw

Based on:

test mat.

95% CL:

>= 670 - <= 895

Effect levels 3

Sex:

male

Dose descriptor:

LD0

Effect level:

ca. 250 mg/kg bw

Based on:

test mat.

Effect levels 4

Sex:

female

Dose descriptor:

LD0

Effect level:

ca. 500 mg/kg bw

Based on:

test mat.

Effect levels 5

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.