Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Principles of method if other than guideline:

Five Wistar rats per sex per dose were exposed to the test substance via intraperitoneal injection. Animals were exposed to 121, 178, 261, 383, 562, 1000, 1470, 2000 mg/kg bw. After an observation period of 14 days animals were necropsied.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

EC Number:

913-404-5

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

Details on test material:

- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)

Specific details on test material used for the study:

- Name of the test material: PVP-JOD FC 1026

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG- Weight at study initiation: mean males 160 – 210 g, mean females 149 – 190 g- Fasting period before study: 16 hours- Housing: 5 animals per cage, in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)- Diet: Kliba-labordiaet, Fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum- Water: tap water, ad libitum- Acclimation period: at least 1 week ENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 24- Humidity (%): 30 - 70- Air: fully air-conditioned- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

olive oil

Details on exposure:

- Administrative volume: 5 mL/kg bw- Justification for choice of vehicle: test substance is insoluble in water

Doses:

121, 178, 261, 383, 562, 1000, 1470, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: recordings of signs and symptoms several times on the day of administration, at least once each workday, check for moribund and dead animals twice each workday and once on holidays- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

309 mg/kg bw

Based on:

test mat.

95% CL:

247 - 390

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

275 mg/kg bw

Based on:

test mat.

95% CL:

186 - 402

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

370 mg/kg bw

Based on:

test mat.

95% CL:

180 - 580

Mortality:

- No mortality observed in all animals exposed to 121 mg/kg bw.- 1 out of 5 males, and 0 out of 5 females exposed to 178 mg/kg bw died.- 3 out of 5 males, and 2 out of 5 females exposed to 261 mg/kg bw died.- 4 out of 5 males, and 3 out of 5 females exposed to 383 mg/kg bw died.- 4 out of 5 males, and 4 out of 5 females exposed to 562 mg/kg bw died.- All animals exposed to 1000 or 1470 mg/kg bw died.- 5 out of 5 males, and 4 out of 5 females exposed to 2000 mg/kg bw died.

Clinical signs:

Clinical signs observed in males:- 121 mg/kg bw: piloerection; animals were symptom-free within 4 days after exposure- 178 mg/kg bw: dyspnea, apathy, staggering piloerection and a poor general state; animals that survived were symptom-free within 3 days after exposure- 261 mg/kg bw: dyspnea, apathy, staggering, piloerection, exsiccosis and a poor general state; animals that survived were symptom-free within 3 days after exposure- 383 mg/kg bw: dyspnea, apathy, staggering, spastic gate, piloerection, exsiccosis and a poor general state; animals that survived were symptom-free within 6 days after exposure- 562 mg/kg bw: dyspnea, apathy, staggering, tremors, twitching, piloerection, exsiccosis and a poor general state; animals that survived were symptom-free within 1 day after exposure- 1000 mg/kg bw: dyspnea, apathy, staggering, atonia, paresis, piloerection and a poor general state- 1470 mg/kg bw: dyspnea, apathy, staggering, paresis, piloerection and a poor general state- 2000 mg/kg bw: dyspnea, apathy, staggering and a poor general stateClinical signs observed in females:- 121 mg/kg bw: piloerection; animals were symptom-free within 1 day after exposure- 178 and 261 mg/kg bw: dyspnea, apathy, staggering, piloerection and a poor general state; animals that survived were symptom-free within 3 days of exposure- 383 mg/kg bw: dyspnea, apathy, staggering, tremors, spastic gait, piloerection, exsiccosis, blood in urine and a poor general state; animals that survived were symptom-free within 13 days after exposure- 562 mg/kg bw: dyspnea, apathy, abnormal position, staggering, tremors, twitching, piloerection, exsiccosis, salivation and a poor general state; animals that survived were symptom-free within 1 day- 1000 and 1470 mg/kg bw: dyspnea, apathy, staggering, paresis, piloerection and a poor general state- 2000 mg/kg bw: dyspnea, apathy, excitation, staggering and a poor general state

Body weight:

Mean body weight males on day 1 and 13 (surviving animals), respectively:- 121 mg/kg bw: 189 g and 270 g- 178 mg/kg bw: 161 g and 250 g- 261 mg/kg bw: 160 g and 213 g- 383 mg/kg bw: 198 g and 252 g- 562 mg/kg bw: 192 g and 278 g- 1000 mg/kg bw: 190 g and -- - 1470 mg/kg bw: 180 g and --- 2000 mg/kg bw: 210 g and --Mean body weight females on day 1 and 13 (surviving animals), respectively:- 121 mg/kg bw: 180 g and 223 g- 178 mg/kg bw: 149 g and 194 g- 261 mg/kg bw: 150 g and 190 g- 383 mg/kg bw: 190 g and 232 g- 562 mg/kg bw: 179 g and 207 g- 1000 mg/kg bw: 180 g and -- - 1470 mg/kg bw: 190 g and --- 2000 mg/kg bw: 189 g and 220 g

Gross pathology:

- Animals that died within the 1st day: liver serosa, acute enteritis, acute gastritis, thorax filled with fluid, lungs slightly inflated, abdominal fluid tinged with blood- Animals that died within the 2nd to the 9th day: intraabdominal fibrin coates and adhesions- Sacrificed animals: intraabdominal adhesions and intraabdominal white coats/fibrin (fibrinous peritonitis/deposits of test substance and thickened margins in the liver. Muddy fluid in the abdomen of two animals.