1,6-Bis(methoxybenzoyloxy)hexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06/07/2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD test method and to GLP standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1070 GA 051

IUPAC Name:

1070 GA 051

Test material form:

solid: crystalline

Details on test material:

- Name of test material: 1070 GA 051
- Substance type: Yelow-white solid
- Physical state: Solid
- Analytical purity: +/- 95%
- Lot/batch No.: LAB
- Expiration date of the lot/batch: 31 May 2001
- Stability under test conditions: Stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx 8 weeks old
- Weight at study initiation: +/- 20% of the sex mean (Mean of 190g for females, 303g for males on Day 1)
- Fasting period before study: Overnight, maximum of 20 hours prior to dosing until approx 3-4 hours after administration of the test substance.
- Housing: 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelletd laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21Centigarde
- Humidity (%): 50% relative
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Remarks:

SG 1.036

Details on oral exposure:

Maximum dose volume applied: 2000mg/kg

Doses:

Single dose on day one. 2000mg/kg (10ml/kg) body weight

No. of animals per sex per dose:

1 group of 3 males and 1 group of 3 females, all with the same 2000mg/kg dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily for mortaility/viability and Body weights on days 1, 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight and macroscopic findings

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No Mortality occured

Clinical signs:

other: No clinical signs were noted

Other findings:

Macroscopic findings: No abnormalities were found at macroscopic post mortem examination of the animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commision Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Executive summary:

The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.

Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commision Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.