bis[2-(2-butoxyethoxy)ethyl] succinate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD 402

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 402 (Acute Dermal Toxicity)

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] succinate

EC Number:

807-645-4

Cas Number:

701920-77-6

Molecular formula:

C20H38O8

IUPAC Name:

bis[2-(2-butoxyethoxy)ethyl] succinate

Constituent 2

Reference substance name:

bis(2-(2-(butoxyethoxy)ethyl)butanedioate

IUPAC Name:

bis(2-(2-(butoxyethoxy)ethyl)butanedioate

Test material form:

other: liquid

Details on test material:

substance type mono constituent
physical state : clear,colourless,liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals
Charles River ,97633 Sulzfeld , Germany
Age 9-10 weeks male, 12-13 weeks females

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

dorso-lumbar-region

Duration of exposure:

24 hours

Doses:

5000 mg/kg/BW

No. of animals per sex per dose:

group of 5 animals males, 5 animals female

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days after dosing.
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of approximately five hours). On subsequent days animals were observed once in daily until the end of the observation period.
Individual body weight were recorded on Days 1, 8 and 15. Individual weekly bodyweight changes and group mean bodyweight data were calculated.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: mortality, dermal respons, macroscopic examination

Statistics:

no data

Results and discussion

Preliminary study:

standard acute method

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

There were no signs of systemic reaction to treatment.

Body weight:

slightly low bodyweight loss were recorded for two female and during the first week, bodyweight trends were comparable for all animals.The decrease was marginal and all animals regained weight in the second week.

Gross pathology:

No macroscopic abnormalities were observed for animals killed on day 15.

Other findings:

no other findings are observed

Any other information on results incl. tables

Dermal response

Local dermal irritation at the treatment site was assessed daily using the following numerical system:

Erythema/Oedema formation for males and females

No erythema/Oedema:  0

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The acute lethal dermal dose to rats of BBSA was found to be greater than 5,0 g/kg bodyweight.

Executive summary:

Acute dermal toxicity was tested in Spraque-Dawley rats at 5.0 g/kg under occlusive dressing. The acute lethal dermal dose to rats of bis(2 -(2 -(butoxyethoxy)ethyl)butanedioate was found to be greater than 5,0 g/kg bodyweight. No macroscopic abnormalities were observed for animals killed on day 15.