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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

RCC Ltd. Toxicology Division, CH-4452 Itingen/Switzerland

Test type:

acute toxic class method

Limit test:

yes

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: JODOSEPT L- Batch No. ZK 1055/175-2- ZHT no: 98/429-1- Storage: In the original container at room temperature, away from direct sunlight

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf/Switzerland- Age at study initiation: males 8 weeks, females 10 weeks- Weight at study initiation: males 209.5 – 220.5 g, females 167.9 – 182.8 g- Fasting period before study: overnight prior to intubation (approx. 17 h)- Housing: in groups of three in Makrolon type-4 cages with standard softwood bedding (“Lignocel”, Schill AG, CH-4132 Muttenz)- Diet: Pelleted standard Kliba 3433, batch no. 28/98, rat maintenance diet (Kliba Mühlen AG, CH-4301 Kaiseraugst) available ad libitum- Water: community tap water from Itingen, ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3 - Humidity (%): 40 - 70 - Air changes (per hr): 10 - 15 - Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled

Details on oral exposure:

VEHICLE - Concentration in vehicle: 20% (w/v) - Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and check for viability: four times during test day 1 and once daily for surviving animals during days 2-15.- Frequency of weighing: On test day 1 (pre-administration), 8 and 15 for surviving animals.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs were checked once daily.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study.

Clinical signs:

No clinical signs were observed during the study period.

Body weight:

The body weight of the animals was within the range of physiological variability known for rats of this strain and age.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met