Di-''isononyl'' phthalate

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: acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

In principle, the methods described in OECD Guideline 401 were used.
Young adult laboratory rats were purchased from a breeder. 5 rats per sex were treated simultaneously by gavage without a vehicle.
Documentation of clinical signs was performed over a 14 day period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
The clinical signs and findings were reported.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Di-''isononyl'' phthalate

EC Number:

249-079-5

EC Name:

Di-''isononyl'' phthalate

Cas Number:

28553-12-0

Molecular formula:

C26H42O4

IUPAC Name:

1,2-bis(7-methyloctyl) benzene-1,2-dicarboxylate

Constituent 2

Reference substance name:

DINP

IUPAC Name:

DINP

Details on test material:

purity >99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

10000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

no animal died within the observation period

Clinical signs:

other: other:

Any other information on results incl. tables

Mortality after	5 males	5 females
1 h	0	0
1 d	0	0
2 d	0	0
7 d	0	0
14 d	0	0

Symptoms in all animals at 10000 mg/kg:

DYSPNEA, APATHY, SPASTIC MOTION, SCRUBBY FUR, ALOPECIA, BAD GENERAL CONDITION

Applicant's summary and conclusion

Executive summary:

No death and no abnormalities observed upon terminal necropsy at a dose level of 10,000 mg/kg Palatinol CE 5250 (CAS 28553-12-0, DINP2) administered undiluted by gavage to ten Sprague- Dawley rats (5 males and 5 females). The observation period was 14 days. Dyspnea, apathy, spastic gait, piloerection, alopecia and poor general state were observed.