Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 6-21, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Relatively well reported study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts

EC Number:

283-041-9

EC Name:

Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts

Cas Number:

84539-53-7

Molecular formula:

non specified (UVCB substance)

IUPAC Name:

non specified (UVCB substance)

Details on test material:

- Name of test material (as cited in study report): Bolikel FE
- Physical state: brown/red crystalline powder
- Lot/batch No.: Batch No. 2
- Storage condition of test material: ambient temperature, under dry conditions
- Other: received on February 27, 1987 (4 x 375 g)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (U.K) Limited, Margate, Kent, England
- Age at study initiation: young adult rats, approximately 5 weeks old
- Weight at study initiation: (pre-fasted) males 110 - 117 g; females 97 - 110 g.
- Fasting period before study: approximately 18 hours before administration of test material
- Housing: 5 animals of the same sex (in type RCI cages with stainless steel grid floors)
- Diet (e.g. ad libitum): fed without restriction (Laboratory animal diet no. 1 from Labsure, Manea, Cambridgeshire, England)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (range 18 - 25)
- Humidity (%): 55 (range 40 - 70)
- Air changes (per hr): 15 complete air changes per hour, without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light per day

IN-LIFE DATES: From: April 6, 1987 To: April 21, 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v formulation in distilled water (250 mg/mL)
- Justification for choice of vehicle: not indicated

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

Dose: 5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (terminated on Day 15)
- Frequency of observations and weighing: Three separate inspections were made during the first hour after administration and two further inspections during the remainder of Day 1. From Day 2 onwards, the animals were inspected twice daily. The type, time of onset and duration of reactions to treatment were recorded. The bodyweight of each animal was recorded on the day before dosing and on Days 1, 8 and 15. The test was terminated on Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died during the first overnight period. There were no other deaths.

Clinical signs:

other: Decreased motor activity, hunched posture, piloerection and urinogenital staining from purple urine were observed in all rats during the first five hours after dosing. Surviving rats were ungroomed on Day 2, but all had fully recovered by Day 3 and remain

Gross pathology:

Necropsy of the decedent revealed fur staining, abnormal gastro-intestinal contents and extensive cannibalisation. Necropsy of the surviving rats revealed red staining of the perineum or ventral surface of several animals and less frequent observations of altered gastro-intestinal contents or dark lungs.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose to rats of Bolikel FE was found to be greater than 5000 mg/kg bodyweight. According to OECD-GHS Bolikel FE is not classified.

Executive summary:

The study was performed according to OECD Guideline 401 (Acute Oral Toxicity) and according to GLP standards.

The test material, Bolikel FE was evaluated in a limit test for its acute oral toxicity potential in rats when administered as a gavage dose at a level of 5000 mg/kg to a group of 5 males and 5 females. One female rat died during the first overnight period. Clinical signs of toxicity included decreased motor activity, hunched posture, pilo-erection and urinogenital staining from purple urine; recovery was complete on Day 3. Gross pathologic examination at termination revealed red staining of the perineum or ventral surface of several animals and less frequent observations of altered gastro-intestinal contents or dark lungs.

The acute oral median lethal dose to rats of Bolikel FE was found to be greater than 5000 mg/kg bodyweight. According to OECD-GHS Bolikel FE is not classified.