Hexanedioic acid, mixed benzyl and 2-(2-methoxyethoxy)ethyl diesters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 May and 03 June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data is based on GLP compliant data accordingly to internationally recognised and EU guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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:

Reaction mass of benzyl 2-(2-methoxyethoxy)ethyl adipate and bis[2-(2-methoxyethoxy)ethyl] adipate and dibenzyl adipate

EC Number:

940-202-4

Cas Number:

1175612-76-6

Molecular formula:

Cannot be assigned to the reaction mass

IUPAC Name:

Reaction mass of benzyl 2-(2-methoxyethoxy)ethyl adipate and bis[2-(2-methoxyethoxy)ethyl] adipate and dibenzyl adipate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

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: Based on exposure of 2000 mg/kg

Mortality:

None

Clinical signs:

None

Body weight:

No effect

Gross pathology:

No effect

Any other information on results incl. tables

MortalityData

 

DoseLevelmglkg	Sex	NumberofAnimals Treated	DeathsDuringDayofDosing(Hours)				DeathsDuringPeriodAfterDosing(Days)								Deaths
			1/2	1	2	4	1	2	3	4	5	6	7	8-14
2000	Female     Female	3     3	0     0	0     0	0     0	0     0	0     0	0     0	0     0	0     0	0     0	0     0	0     0	0     0	0/3     0/3

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 >2500 mg/kg

Executive summary:

The acute oral toxicity has been assessed using the OECD 423 Acute toxic class method in female rats by gavage. No mortality was noted, with no clinical signs of toxicity or histological effect. Based on dosing of the substance with no vehicle at 2000 mg/kg the LD50 is extrapolated to be >2500 mg/kg.