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Administrative data

Description of key information

In Guideline conform repeated dose studies with 28 and 90 days of oral treatment NOAELs between 200 and 1000 mg/kg bw/day were determined for rats. Two not assignable acute oral toxicity studies revealed an LD50 of 1600 mg/kg bw for rat, mouse, and guinea pig and an LD50 of 800 mg/kg bw for the rat. For mice LD50s of 1500 and 1370 mg/kg bw were reported. A not assignable acute dermal toxicity study stated an LD50 of > 20.000 mg/kg bw. The key-study for acute inhalation toxicity determined a LC50 > 8817 mg/m³.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source
Principles of method if other than guideline:
no data
GLP compliance:
no
Test type:
other: no data
Species:
other: rat, mouse, guinea pig
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Remarks on result:
other: rat, mouse, guinea pig

The signs observed with this material are those of anesthesia in the larger doseages. The animals either die promptly from deep anesthesia or recover completely by the next day. In smaller dosages minimal or no signs are observed

Interpretation of results:
harmful
Remarks:
Migrated information
Executive summary:

LD50(rat, mouse, guinea pig) = 1600 mg/kg bw.

The signs observed with this material are those of anesthesia in the larger doseages. The animals either die promptly from deep anesthesia or recover completely by the next day. In smaller dosages minimal or no signs are observed

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 600 mg/kg bw
Quality of whole database:
By a weight of evidence consideration the available data are sufficient for classification of triethyl phospahte concerning the oral route

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Qualifier:
according to
Guideline:
other: TSCA-Guideline §798.1150
GLP compliance:
yes
Test type:
other:
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
other: whole body (except tail)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1400; 3360; 8817 mg/m3 air.
No. of animals per sex per dose:
5/sex/dose
Control animals:
yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 8 817 mg/m³ air
Exp. duration:
4 h
Mortality:
No mortalities.
Clinical signs:
other: 3360 mg/m³ = untended fur, diminuated motility, miosis, bloody snout. 8817 mg/m³ = untended fur, piloerection, diminuated motility ,ataxia, miosis, diminuated breathing, accelerated breathing.
Body weight:
Marginal retardation in weight gain in male rats in the first week in groups with 3360 mg/m³ and 8817 mg/m³.
Gross pathology:
No signs of organ damages.

Akute inhalation toxicity-aerosol

 Concentration nomin.analyt. mg/m³ air  Toxicological result   Duration of symptoms  Timepoint of death  Particle < 3 µm (%)
 rat (male)               
 Air-control    0/0/5*  --  --  -
 21200  1400  0/0/5  --  --  60
 53000  3360  0/5/5  4h-1d  --  21
 106000  8817  0/5/5  4h-4d  --  22
 rat (female)               
 Air-control   0/0/5  --  --  -
 21200  1400  0/0/5  --  --  60
 53000  3360  0/5/5  4h-6h  --  21
 106000  8817  0/5/5  4h-2d  --  22

LC50: > 8817 mg/m³ air

* = No.of mortalities/ No.of animals with symptoms/ No.of animals used

Interpretation of results:
sligthly toxic
Remarks:
Migrated information
Executive summary:

In an acute inhalation toxicity study in rats performed according to OECD 403 triethyl phosphate showed no acute inhalation toxicity.

Clinical signs observed in the 3360 mg/m³ air group were: untended fur, diminuated motility, miosis, bloody snout and in the 8817 mg/m³ air group: untended fur, piloerection, diminuated motility ,ataxia, miosis, diminuated breathing, accelerated breathing.

Marginal retardation in weight gain in male rats in the first week could be remarked at 3360 mg/m³ and 8817 mg/m³ air.

The LC50 was > 8817 mg/m³ air.

The NOEL was 1400 mg/m³ 4h air.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
8 817 mg/m³
Quality of whole database:
GLP guideline study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

From the oral repeated dose studies (overall NOAEL = 200 mg/kg bw) and a weight of evidence consideration (LD50 = 1600 mg/kg bw, LD50 = 800 mg/kg bw) for rats and the not assignable studies in mice an overall LD50 > 1000 mg/kg bw seems justified.

Acute inhalation LD50 > 8817 mg/m³ was reported in a guideline study without restrictions. There are no reliable acute dermal toxicity studies available. In a study in rabbits a dermal LD 50 > 20000 mg/kg bw was determined as reported in a peer-reviewed report.


Justification for selection of acute toxicity – oral endpoint
Several oral studies are available. The determined LD50 values were all in the range > 800 mg/kg bw and ca. 1600 mg/kg bw. In rats mice and guinea pigs a LD50 of ca. 1600 mg/kg bw was determined. By a weight-of evidence conideration the data by Deichmann seems most reliable and the LD50 values from this publication were selected as effect level.

Justification for selection of acute toxicity – inhalation endpoint
The most reliable study was used as key study and for classification.

Justification for classification or non-classification

Based on a weight-of-evidence evaluation of acute and repeated dose studies a LD50 of > 1000 mg/kg bw is justified. Therefore a classification with Acute Tox 4 (H302: Harmful if swallowed) is warranted. This classification is supported by a weight-of-evidence consideration of the available not assignable studies.

A classification for acute dermal and acute inhalation toxicity is not justified from the availabe data.