2,4,8,10-Tetraoxaspiro[5.5]undecane-3,9-diethanol, .beta.3,.beta.3,.beta.9,.beta.9-tetramethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-06-01 to 2006-06-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test was performed according to guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-230-3

EC Name:

-

Cas Number:

1455-42-1

Molecular formula:

Hill formula: C15H28O6 CAS formula: C15H28O6

IUPAC Name:

2-[9-(1-hydroxy-2-methylpropan-2-yl)-2,4,8,10-tetraoxaspiro[5.5]undecan-3-yl]-2-methylpropan-1-ol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): SPG
- Physical state: White powder
- Lot/batch No.: 50908-02
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: Eight to twelve weeks of age
- Weight at study initiation: Bodyweights fell within an interval of ± 20 % of the mean initial bodyweight of the first treated group.
- Fasting period before study: Overnight
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): Free access to Certified Rat and Mouse Diet (Code 5LF2; BCM IPS Ltd, London, UK) except for the overnight fast prior to dosing and for approximately 3 to 4 hours after dosing.
- Water (e.g. ad libitum): Free access to mains drinking water except for the overnight fast prior to dosing and for approximately 3 to 4 hours after dosing.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 70 %
- Air changes (per hr): At least 15.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light and twelve hours continuous darkness.

IN-LIFE DATES: From: Day 1 To: Day 14

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: The test material did not dissolve/suspend in distilled water.
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION: No data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for death or overt signs of toxicity 0.1, 1, 2 and 4 h after dosing and subsequently once daily for 14 days.
Individual body weights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: There were no deaths and no signs of systemic toxicity.

Mortality:

There were no deaths during the study.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bw (Globally Harmonised Classification System - Unclassified).

Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:

OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxicity Class Method” (Adopted 17 December 2001)

Method B1trisAcute Toxicity (Oral) of Commission Directive 2004/73/EC.

 

Method

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.

The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Results

Mortality. There were no deaths.

Clinical observations. There were no signs of systemic toxicity.

Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.

 

Conclusion

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification System – Unclassified).