(6-aminohexyl)carbamic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Acute Oral Gavage (pre-guideline pre-GLP study)
- Short description of test conditions: The test material was administered by intragastric intubation to five group of ten young adult rat at dose of 5000, 3400, 3020, 2630, 2250 mk/kg. Surivors were sacrificed 14 days later. The oral LD50 was calculated.
- Parameters analysed / observed: Cliinical signs, gross pathologic changes

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(6-aminohexyl)carbamic acid

EC Number:

205-581-6

EC Name:

(6-aminohexyl)carbamic acid

Cas Number:

143-06-6

Molecular formula:

C7H16N2O2

IUPAC Name:

(6-aminohexyl)carbamic acid

Test animals

Species:

rat

Strain:

CD-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species: Charles River CD
- Sex: males

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Vehicle detalies not specified

Doses:

5000, 3400, 3020, 2630, 2250 mg/kg

No. of animals per sex per dose:

5 groups - 10 animals each group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: clinical signs, Gross pathologic changes

Statistics:

Oral LD50 calculated from mortality data using the method of Litchfield and Wilcoxon (1949).

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 875 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 614 - <= 3 162

Mortality:

2250 mg/Kg - 1/10
2630 mg/Kg - 2/10
3020 mg/Kg - 7/10
3400 mg/Kg - 8/10
5000 mg/Kg - 10/10

Clinical signs:

other: Pallor, apparent discomfort, belly-crawling after dosing, weight loss for 1-2 days, diarrhoea, stained ventral area and hematuria at two higher doses.

Gross pathology:

Animals that died (5): dark bone marrow, hyperemic thymus, stomach and intestine distended with fluid, intestine and glandular mucosa of stomach hemorrhagic
Animal that survived (8): thickened stomach mucosa and, at higher levels, adhesions of liver to stomach

Any other information on results incl. tables

Mortality observed in the study

Dose mg/kg	Solution %	Mortality Ratio
5000	50	10/10
3400	20	8/10
3020	30	7/10
2630	30	2/10
2250	40	1/10

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation

Conclusions:

Under the conditions of this study, the acute oral LD50 of the test material in male rats was determined to be 2875 mg/Kg (95% C.I: 2614 - 3162 mg/Kg).

Executive summary:

In a key pre-guideline acute oral toxicity study, the test material was administered via intragastric intubation to Charles River CD rats (10 males/dose) at doses of 2250, 2630, 3020, 3400, or 5000 mg/Kg. Animals were observed for clinical signs and gross pathologic changes with surviving animals sacrificed 14 days post exposure.

 

Mortality was observed at each dose level as follows: 2250 mg/Kg (1/10); 2630 mg/Kg (2/10); 3020 mg/Kg (7/10); 3400 mg/Kg (8/10); 5000 mg/Kg (10/10). Clinical signs observed through the study period included pallor, discomfort, belly-crawling after dosing, weight loss for 1-2 days, diarrhoea, stained ventral area as well as hematuria observed at the two higher doses.

 

Dark bone marrow, hyperemic thymus, stomach and intestine distended with fluid, and hemorrhagic intestine and glandular mucosa of the stomach were observed in animals that died (5). In animals that survived (8), thickened stomach mucosa and, at higher dose levels, adhesion of the liver to the stomach were observed. 

 

Based on mortality and clinical signs of toxicity as well as gross pathology observed in the study, the acute oral LD₅₀ (calculated using the Litchfield and Wilcoxon method (1949)) was determined to be 2875 mg/Kg (95% C.I: 2614 – 3162 mg/Kg).