Hexanedioic acid, di-C16-18 (even numbered) alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 - 15 Mar 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Report was limited, study was not GLP conform and purity of test substance was not given.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

secondary source

Title:

Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)

Author:

US-EPA (American Chemistry Council's Aliphatic Esters Panel)

Year:

2010

Bibliographic source:

High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

purity of test substance not given

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(tridecyl) adipate

EC Number:

241-029-0

EC Name:

Bis(tridecyl) adipate

Cas Number:

16958-92-2

Molecular formula:

C32H62O4

IUPAC Name:

ditridecyl adipate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: Animals were fasted 18 h prior to administration of the test material.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

On the day of application all animals showed diarrhea. Over the course of the study numbers of animals with diarrhea declined (1 male and female on day 1, and two males each on day 2 to day 4). Thereafter, no diarrhea was observed until day 13 and day 14 when 1 male each showed diarrhea. Other symptoms were lethargy from day 0 to day 2 shown by 2 males and females each, 1 male and female each and 1 male, respectively. Additionally, on day 0 one male animal appeared flaccid. From day 2 to day 4 all animals had an oily body, on day 2 and day 3 one male showed ptosis and on day 12 and 13 one male and on day 14 two male animals showed chromorhinorrhea.

Any other information on results incl. tables

Table1: Overview of clinical symptoms observed in rats treated by single oral gavage with 15000 mg/kg bw of test item

	Number of rats with clinical signs (male/female)
Day	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
Diarrhea	5/5	1/1	2/0	2/0	2/0	-	-	-	-	-	-	-	-	1/0	1/0
Lethargy	2/2	1/1	1/0	-	-	-	-	-	-	-	-	-	-	-	-
Flaccid	1/0	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Oily body	-	-	5/5	5/5	5/5	-	-	-	-	-	-	-	-	-	-
Ptosis	-	-	1/0	1/0	-	-	-	-	-	-	-	-	-	-	-
Chromorhinorrhea	-	-	-	-	-	-	-	-	-	-	-	-	1/0	1/0	2/0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

CLP: not classified