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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

There were no signs of acute toxicity via the oral, dermal or inhalation routes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No further information available.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Other (1980).
GLP compliance:
yes
Test type:
other: Needed for data submission
Limit test:
yes
Species:
rat
Strain:
other: Sherman/Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR, Part 3.


Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass exposure chamber
- Exposure chamber volume: 260-L
- Source and rate of air: rate of flow through the chamber was 20 L/min
- System of generating particulates/aerosols: The material was administered as an aerosol, which was generated by a six-jet Collision nebulizer (BGI Incorporated, Waltham, MA). The air was passed through a desicant prior to being passed through the test material.
- Method of particle size determination:
- Temperature: 72o F

TEST ATMOSPHERE
- Brief description of analytical method used: The average concentration of the aerosol over the one-hour exposure period was calculated to be 12.6 mg/L by differential weighing of the flask from which the aerosol was generated. The particle size (mass median diameter) of the aerosol of the test material was determined, to assure that the animals received a respirable dose, using an Andersen Sampler cascade impactor. The sampler was run for 5 minutes midway through the exposure. During sampling, air from the breathing zone of the animals was drawn through the cascade impactor at the rate of 1 ft3/min. The amount of aerosol impacting on each plate of the Andersen Sampler was determined by differential weighing. From these values the mass median diameter of the aerosol was calculated to be 0.48 microns and the concentration was calculated to be 0.10 mg/L.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
No further information available.

No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days


Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 12.6 mg/L air
Mortality:
No animals died during the experiment.
Clinical signs:
other: No adverse effects were observed during the one-hour exposure period. No untoward signs and symptoms were observed during the 21-day post-exposure observation period.
Gross pathology:
Gross pathological examination revealed no remarkable findings.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no signs of acute inhalation toxicity based on exposure to an aerosol (above vapour saturation point).
Executive summary:

LC50 (aerosol) was >12.6 mg/L. The substance is not acutely toxic via the inhalation route and not classifiable.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
12 600 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD 402, except this limit test used 3 animals/sex rather than 5/sex as recommended by the OECD guideline.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Other (1980). The method employed in the testing, evaluation, and the scoring of the results was similar to the methods described in Section 1500.40 of the U.S. Federal Hazardous Substances Act Regulations, 16 CFF, pg. 123.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 and 3.0 kg


Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: These treated areas were covered with large gauze patches and an impervious material was wrapped around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess material was removed.
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
5.0 g/kg body weight

No. of animals per sex per dose:
3

Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days


Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died during the experiment.

Clinical signs:
No signs of toxicity, except for substantial skin irritation lasting over several days.

Gross pathology:
Gross pathological examination revealed no remarkable findings.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No signs of dermal toxicity at the limit dose of 5 g/kg.
Executive summary:

No acutely toxic via the dermal route at limit dose of 5 g/kg. Not classified as acutely toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

There are no indications of acute toxicity via the oral route for TiTDP (Lowe 2014). In addition, there was no acute toxicity via the oral, dermal or inhalation routes for close analogue - triisodecyl phosphite (TDP).  

Use of TDP dermal acute toxicity data as read-across to TiTDP appears appropriate based on the similar acute toxicity of these alkyl phosphites. From the enhanced read-across justification (Section 13), it is also noted that the corresponding alkyl alcohols (hydrolysis products) for these phosphites also have low dermal toxicity.

Given the extremely low vapour pressure of TiTDP, it is not feasible to test via the inhalation route. Read-across data from TDP for the acute inhalation endpoint has been used in the CSR, though inhalation is not considered to be a major exposure pathway.

Justification for selection of acute toxicity – oral endpoint

No acute oral effects observed at the limit dose.

Justification for selection of acute toxicity – inhalation endpoint

No effects observed in an acute aerosol inhalation toxicty study done on close analog, triisodecyl phosphite. Substance is not volatile and inhalation exposure is not expected to occur so a waiver has been submitted for this endpoint.

Justification for selection of acute toxicity – dermal endpoint

No effects observed in an acute dermal toxicity study done on close analog, triisodecyl phosphite. Substance is classified as a skin sensitiser so exposure to skin is already being controlled. A waiver has been submitted for this endpoint.

Justification for classification or non-classification

The following information is taken into account for any hazard / risk assessment:

There were no signs of acute toxicity via the oral and read-across data from TDP suggests no acute toxicity via the dermal or inhalation routes.

The results justify non classification.