Bis(2-(2-butoxyethoxy)ethyl) adipate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Oct 1996 - 4 Nov 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Reference 2

Reference Type:

secondary source

Title:

EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester

Author:

US EPA

Year:

2011

Bibliographic source:

High Production Volume Chemical Challenge Program

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of details on test substance

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-(2-butoxyethoxy)ethyl) adipate

EC Number:

205-465-5

EC Name:

Bis(2-(2-butoxyethoxy)ethyl) adipate

Cas Number:

141-17-3

Molecular formula:

C22H42O8

IUPAC Name:

bis(2-(2-butoxyethoxy)ethyl) adipate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Ace Animals, Inc., Boyertown, PA, USA- Age at study initiation: approximately 6 - 9 weeks- Weight at study initiation: 222 - 254 g- Fasting period before study: 18 hours- Housing: stainless steel, indirect bedding- Diet: Lab Diet Certified Rodent Diet #5002, ad libitum- Water: ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 21 Oct 1996 - 4 Nov 1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

After 18 hours of fasting and prior to dosing, all rats (5 male: 5 female) were weighed and marked with ear clips. The weight variations of animals did not exceed ±20%. Individual doses were administered on the basis of body weight using a stainless steel intragastric feeding needle. Volumes of dose were 1.1 to 1.2 mL in all cases.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: animals were observed at 1, 3, 6 and 24 hours and daily thereafter for a total of 14 days.- Frequency of observations and weighing: at least once daily- Necropsy of survivors performed: complete gross necropsy performed on animals sacrificed at the end of the 14-day observation period. Sacrifice was accomplished via carbon dioxide asphyxiation.- Other examinations performed: animals were observed for signs of pharmacological activity and drug toxicity

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

A single male rat died by the 24 hour observation period.

Clinical signs:

other: Depression was noted in the single male animal that died. Slight depression was recorded in a single other male rat but this resolved by the 24 hour observation period. All other male rats appeared normal.Slight depression was noted in 3/5 female rats but

Gross pathology:

In 3 female rats, a red discharge was noted around the nose. The small intestines appeared moderately reddened. The stomachs appeared ulcerated.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

CLP: not classifiedDSD: not classified