Diisotridecyl phenyl phosphite

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triisotridecyl phosphite

EC Number:

278-758-9

EC Name:

Triisotridecyl phosphite

Cas Number:

77745-66-5

Molecular formula:

C39H81O3P

IUPAC Name:

triisotridecyl phosphite

Test material form:

other: liquid

Details on test material:

Triisotridecyl phosphite
Lankromark LE571
Batch: W024077 (3284/047)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The undiluted test substance was administered to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

An initial limit dose of 2,000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females received the same dose level, sequentially. Since these animals survived, no additional animals were tested. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration (initial) and again on Days 7 and 14 (terminal) following dosing (see Section 9). Necropsies were performed on all animals at terminal sacrifice.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality at limit dose

Mortality:

None

Clinical signs:

No signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

Body weight:

All animals gained weight during the study.

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the acute oral LD50 of triisotridecyl phosphite is greater than 2,000 milligrams per kilogram of body weight in female rats. In accordance with the provisions of Regulation (EC) Number 1272/2008 amended by Commission Regulation (EU) Number 286/2011 of 10 March 2011 (ATP002) on the Classification, Labeling, and Packaging of Substances and Mixtures, classification is not required based on the results of this study.

Executive summary:

Under the conditions of this study, the acute oral LD50 of triisotridecyl phosphite is greater than 2,000 milligrams per kilogram of body weight in female rats. In accordance with the provisions of Regulation (EC) Number 1272/2008 amended by Commission Regulation (EU) Number 286/2011 of 10 March 2011 (ATP002) on the Classification, Labeling, and Packaging of Substances and Mixtures, classification is not required based on the results of this study.