Tetraol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-11-25 to 2014-12-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17, 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot 003
- Expiration date of the lot/batch: January 2020

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; no direct sunlight; protect against humidity
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 183 - 192 g
- Fasting period before study: at least 16 hours
- Housing: single
- Diet: ad libitum, VRF1(P) (SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % solution (Dow Wolff Cellulosics GmbH) in deionized water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: A good homogeneity in water could not be guaranteed, because the test item preparation was a suspension. Therefore a 0.5% solution of CMC in deionized water was applicable.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

300, 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 weighing: observations daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both 2000 mg/kg bw test groups and in the single 300 mg/kg bw test group.

Clinical signs:

In the first 2000 mg/kg bw test group impaired general state and piloerection was noted from hour 1 or 2 until hour 5 after administration. One of these animals additionally showed cowering position from hour 2 until hour 3.
In the second 2000 mg/kg bw test group impaired general state and piloerection was observed in all animals from hour 1 or 2 until hour 3 or 5 after administration.
In the single 300 mg/kg bw test group impaired general state and piloerection was noticed in one animal from hour 0 until hour 3, while the other two animals were free of any symptoms.

Body weight:

The mean body weight of all animals increased within the normal range throughout the study period.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (9 females).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met