Cyanoacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The animals were dosed between 1979-06-21 and 1979-07-26.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, no GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

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:

BASF Test (BASF internal method). In principle, the methods described by OECD TG 401 are followed.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyanoacetic acid

EC Number:

206-743-9

EC Name:

Cyanoacetic acid

Cas Number:

372-09-8

Molecular formula:

C3H3NO2

IUPAC Name:

cyanoacetic acid

Details on test material:

- Name of test material (as cited in study report): Cyanessigsäure (cyanoacetic acid)
- Analytical purity: not given
No further data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
male and female Sprague-Dawley rats
- Source: Hagemann
- Weight at study initiation: mean body weights: 210 - 280 g (males); 180 - 210 g (females)
- Fasting period before study: 15 - 20 h prior to dosing
- Diet (ad libitum): Herilan MRH Haltungsdiät (H. Eggersmann KG)
- Water (ad libitum): tap water

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
distilled water
- Concentration in vehicle: 4.64, 6.81, 10.00, 14.70, 21.50 % (w/v)

DOSE VOLUME APPLIED: 10 ml/kg bw for all dose groups

Doses:

464, 681, 1000, 1470, 2150 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: (a) mortality check: 1h, 1d, 2d, 7d, 14d after dosing; (b) weighing: 2-4d, 7d, 13d after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Probit Analysis according to Finney DJ (1971). Probit Analysis. Cambridge University Press, 3rd ed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 010 mg/kg bw

95% CL:

831 - 1 228

Remarks on result:

other: slope factor: 1.45

Mortality:

Mortality after 14 days:
464 mg/kg bw: 0/10
681 mg/kg bw): 1/10
1000 mg/kg bw: 7/10
1470 mg/kg bw: 7/10
2150 mg/kg bw: 10/10
All deaths occurred within the first day after dosing. For more details, see below, table 1.

Clinical signs:

other: 464 and 681 mg/kg bw: no clinical signs. 1000 mg/kg bw: dyspnea, wheezing, apathy, staggering, piloerection, poor general state. 1470 mg/kg bw: dyspnea, apathy, anomal position, staggering, tremor, exsiccosis, paresis, poor general state. 2150 mg

Gross pathology:

Pathology of the decedents revealed changes of the heart (acute dilatation at the right side, acute congestive hyperemia), liver (dark-gray coloration, reddish-brown marmoration), and stomach (whitish mucosa, hemorrhagic ulceration). No pathological abnormalities were found in survivors that had been sacrificed at the end of the observation period.

Any other information on results incl. tables

Table 1: mortality data

Dose level [mg/kg]		464	681	1000	1470	2150
males
No. of animals		5	5	5	5	5
Dead animals after	1 h 1 d 2 d 7 d 14 d	0 0 0 0 0	0 0 0 0 0	0 3 3 3 3	0 3 3 3 3	1 5 5 5 5
females
No. of animals		5	5	5	5	5
Dead animals after	1 h 1 d 2 d 7 d 14 d	0 0 0 0 0	0 1 1 1 1	0 4 4 4 4	0 4 4 4 4	3 5 5 5 5

Table 2: body weight data

Dose level [mg/kg]		464	681	1000	1470	2150
males
Initial body weight [g]		230	210	280	210	230
Body weight [g] after	2-4 d 7 d 13 d	253 285 312	230 267 303	277 271 272	183 224 265	All animals were dead by day 1.
females
Initial body weight [g]		180	170	210	190	190
Body weight [g] after	2-4 d 7 d 13 d	190 201 195	186 193 206	210 233 235	184 211 233	All animals were dead by day 1.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information