2,5-Furandione, reaction products with 2-ethyl-1-hexanamine and triethanolamine

Acute Toxicity: oral

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 standards, well documented and acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(2E)-3-({3-carboxy-3-[(2-ethylhexyl)amino]propanoyl}(2-ethylhexyl)carbamoyl)prop-2-enoic acid; (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoic acid; (2E)-4-{2-[bis(2-hydroxyethyl)amino]ethoxy}-4-oxobut-2-enoic acid; 2-[(2-hydroxyethyl)amino]ethyl (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoate

EC Number:

939-488-3

Cas Number:

1471311-93-9

Molecular formula:

C18 H36 N2 O6

IUPAC Name:

(2E)-3-({3-carboxy-3-[(2-ethylhexyl)amino]propanoyl}(2-ethylhexyl)carbamoyl)prop-2-enoic acid; (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoic acid; (2E)-4-{2-[bis(2-hydroxyethyl)amino]ethoxy}-4-oxobut-2-enoic acid; 2-[(2-hydroxyethyl)amino]ethyl (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoate

Details on test material:

- Name of test material (as cited in study report): Korantin SC 9437 (now: Korantin MAT)
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA
- Weight at study initiation: mean males: 254 g, mean females: 200 g
- Fasting period before study: 15-20 hours
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 21.5 %, 31.6 % and 50 %

MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg

Doses:

2150, 3160, 5000, 6810, 10000

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily, weighing was performed on day 0, day 2-4, day 7 and day 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 752 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 904 - <= 5 698

Mortality:

2150 mg/kg: no deaths
3160 mg/kg: 2/5 males and 0/5 females died
5000 mg/kg: 2/5 males and 2/5 females died
6810 mg/kg: 5/5 males and 4/5 females died
10000 mg/kg: all animals died

Clinical signs:

other: observed clinical signs included: dyspnea, stertor, apathy, abnormal position, staggering, paresis (hind leg), spastic gait, piloerection, erythema, exsiccosis, exophthalamus, salivation, blood (in the nose and/or in the urine), poor general state. Not al

Gross pathology:

animals that died: Heart: acute atrial dilatation; acute congestive hyperemia; stomach: diffuse reddening of true stomach; intestines: atonic, mucosal reddening, diarrhea and hematinic contents.
sacrificed animals: nothing unusual was observed