2-ethylhexyl diphenyl phosphate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Concise report, but method provided, no GLP, similar to OECD Guideline 403

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

5 animals

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

not yet introduced

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl diphenyl phosphate

EC Number:

214-987-2

EC Name:

2-ethylhexyl diphenyl phosphate

Cas Number:

1241-94-7

Molecular formula:

C20H27O4P

IUPAC Name:

2-ethylhexyl diphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): Santicizer 141
- Physical state: liquid
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: mature
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: metal chamber of 35-liters capacity
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 54
- Air changes (per hr): air flow rate: 4 l/min.
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
- Exposure chamber volume: 35 l.
- Method of holding animals in test chamber: no data
- Source and rate of air: Air flow through the sample was 4.0 l/m as measured by a calibrated rotameter
- Method of conditioning air:
- System of generating particulates/aerosols: a concentrated atmosphere of vapors was produced by passing a stream of air through 140.0 grams of the test compound contained in a 250-ml erlenmeyer flask. The sample was maintained at a temperature of 162.7 °C by immersing the flask in a heated sand bath. Vapors from the flask passed into a one liter bottle to remove droplets and then into the chamber.
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: 23 °C, 54%, pressure unknown.

TEST ATMOSPHERE
- Brief description of analytical method used: The test system is exposed to a concentrated atmosphere of the vaporized test material. Amount of Sample: To start: 140.0 grams; Recovered: 135 0 grams; Total vaporized: 5.0 grams (3.6%); Recovered from condenser: 2.0 grams (1.4%); Weight of vapors entering chamber: 3.0 grams (2.2%)
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 6 h

Concentrations:

2.1 mg/l (nominal, calculated from data)

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: 1 to 2 hours; 3 to 4 hours; 5 to 6 hours during exposure. Day 1, 2, 3, 5, 8, and 10 during observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 2.1 mg/L air

Based on:

test mat.

Remarks:

Total weight vaporized minus recovered from condenser

Exp. duration:

6 h

Mortality:

3 out of 5 animals died (one on day 3, one on day 5 and one on day 8 of observation period)

Clinical signs:

other: Observations during exposure: 1 to 2 hours: Animals appeared unaffected 3 to 4 hours: Lethargy, slight nasal discharge, slow reflexes 5 to 6 hours: Slight ocular discharge, labored breathing, and tremors in some animals Observations during ten day period

Body weight:

On the 10th day of observation two surviving animals showed 30 to 40 % weight loss.

Gross pathology:

Autopsy of the succumbed animals #3 and #4 showed hemorrhagic areas of lungs, light liver discoloration, and gastrointestinal inflammation {yellowish slime in intestines). Animal #5 showed lung congestion, liver discoloration, and acute gastrointestinal inflammation. Surviving animals were sacrificed ten days following exposures. Macroscopic examination revealed congestion of lungs; otherwise the viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All animals survived the 6 hour exposure period; 3 of 5 test animals succumbed during the 10 day observation period. It was concluded that the vapors were harmful under conditions of the test. The LC50 was calculated to be 2.1 mg/l for 6 h exposure. Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS) Santicizer 141 needs to be classified as harmful by inhalation.

Executive summary:

The acute inhalation toxicity of Santicizer 141 towards rats was investigated in a test similar to OECD Guideline 403. Five male rats were exposed to Santicizer 141 at a concentration of 2.1 mg/l for 6 hours. The procedure is designed to provide a single inhalation exposure at an elevated temperature to a concentrated atmosphere of the vaporized test material for potential toxic effects. Signs of intoxication and mortality are observed during the observation period of 10 days. All animals survived the 6 hour exposure period; 3 of 5 test animals succumbed during 10 day observation period. It was concluded that the vapors were harmful under conditions of the test. The LC50 was calculated to be 2.1 mg/l (nominal concentration) for 6 h exposure. Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS) Santicizer 141 needs to be classified as harmful by inhalation.