Reaction product of adipic acid and sebacic acid and isotridecan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (no determination of body weights, limited reporting), read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

; no determination of body weights, limited reporting

Principles of method if other than guideline:

No guideline stated in report, but method used is similar to OECD TG 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diisotridecyl adipate

EC Number:

247-660-8

EC Name:

Diisotridecyl adipate

Cas Number:

26401-35-4

IUPAC Name:

bis(11-methyldodecyl) adipate

Details on test material:

- Name of test material (as cited in study report): MCTR-25-78
- Physical state: yellow liquid
- no further information on test material

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: approx. 18 h

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

15.0 g/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: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test, 15000 mg/kg bw is the only dose tested

Mortality:

no mortalities were obserded (0/10 animals)

Clinical signs:

Diarrhea (from day 0 to day 4 with reducing number of animals)
Lethargy (from day 1 to day 2 in few animals)
Body oily (from day 2 to day 5 in all animals)
Chromorhinorrhea (from day 12 to day 14 in 1 to 2 male animals)

Body weight:

no data

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity test (only 1 dose, limit test), diisotridecyl adipate did not cause any mortality at a dose of 15000 mg/kg bw. Diisotridecyl adipate is not to be classified according to EU regulations.

Executive summary:

The acute oral toxicity of diisotridecyl adipate was determined in 5 male and 5 female Wistar rats each receiving 15 g/kg bw of the test material by oral gavage (limit test). The observation period was 14 days.

 

None of the animals died. Clinical signs (diarrhea, lethargy, oily bodies) were observed predominantly during day 0 to 5. Information on gross pathology is not reported.

 

The acute oral LD50 was determined to be > 15000 mg/kg bw in rats (Moreno/Mobil, 1978a).

 

This study is considered acceptable. It follows the principles of the retracted OECD test guideline 401 (Acute Oral Toxicity). Deviations are no determinatin of body weights and limited reporting.