Isodecyl diphenyl phosphate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 October 1983 - 27 October 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Clear report, early 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:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Remarks:

early GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isodecyl diphenyl phosphate

EC Number:

249-828-6

EC Name:

Isodecyl diphenyl phosphate

Cas Number:

29761-21-5

Molecular formula:

C22H31O4P

IUPAC Name:

isodecyl diphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): Santicizer 148
- Physical state: liquid
- Analytical purity: confidential
- Lot/batch No.: confidential
- Stability under test conditions: no data
- Storage condition of test material: Temperature monitored room (15.6 – 29.4 °C)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories Wilmington, Delaware 01887, USA
- Age at study initiation: Males: 9 weeks; Females: 10 weeks
- Weight at study initiation: Males- Mean: 274 g (range 246 to 303 g); Females - Mean: 229 g (range: 222 to 238 g)
- Fasting period before study: no data
- Housing: Animals were group housed in elevated stainless steel wire mesh cages during the acclimation period and individually housed during all subsequent non-exposure periods.
- Diet: ad libitum, standard laboratory diet (Purina-Rodent Laboratory Chow)
- Water: ad libitum, by automated watering system (Elizabethtown Water Company)
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 - 24.4
- Humidity (%): 25-76
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: no data

Administration / exposure

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: 100 liter
- Method of holding animals in test chamber: no data
- Source and rate of air: flow rate: 10 l/min.
- Method of conditioning air:
- System of generating particulates/aerosols: A large three-neck round bottom flask fitted with a Laskin Aerosol Generator.
- Method of particle size determination: Particle size distribution samples were obtained using a Casella cascade impactor at approx. 1 hour intervals throughout the exposure. The distribution was calculated based on the amount of test substance collected on the impactor stages (glass slides).
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: A thermometer and Airguide relative humidity indicator were used to record temperature and humidity in the chamber. Recordings were made at approx. hourly intervals throughout the exposure. The average chamber temperature and humidity were 25°C and 35%, resp.

TEST ATMOSPHERE
- Brief description of analytical method used:Gravimetry
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Analysis of particle size distribution data revealed a mass median aerodynamic diameter of 2.5 microns with a geometric standard deviation of 2.4

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The amount and distribution of the test substance was determined gravimetrically. Particle size distribution samples were obtained using a Casella cascade impactor

Duration of exposure:

ca. 4 h

Concentrations:

Nominal exposure concentration: 13 mg/l
Mean analytical concentration (gravimetry): 6.3 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed prior to exposure, at approximately 15 minute intervals during the first hour of exposure, hourly for the remainder of the exposure, upon removal from the chamber, and hourly for two hours post-exposure. Detailed observations were recorded at each interval. Body Weight: Day I (immediately prior to exposure) and on Days 2, 3, 5, 8 and 15 (post-exposure period).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Statistics:

Not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 6.3 mg/L air (analytical)

Exp. duration:

4 h

Remarks on result:

other: No deaths. Signs exhibited during exposure: increases in secretory responses and reduced activity. Signs during the post-exposure period: incidences of secretory responses, rough coat and yellow ano-genital fur A transient decrease in body weight.

Effect levels 2

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 13 mg/L air (nominal)

Exp. duration:

4 h

Remarks on result:

other: No deaths. Signs exhibited during exposure: increases in secretory responses and reduced activity. Signs during the post-exposure period: incidences of secretory responses, rough coat and yellow ano-genital fur A transient decrease in body weight.

Mortality:

No mortality was observed.

Clinical signs:

other: Exposure observations revealed some to most animals exhibited lacrimation, salivation, chromodacryorrhea and reduced activity during the entire exposure. Upon removal from the chamber, the animals exhibited increased incidences of secretory responses (lac

Body weight:

Slight decreases in body weights for both sexes of animals were exhibited following exposure (Test Day 2). Most of the females had regained their pretest body weights by Test Day 3; however, all males did not regain their pretest body weights until Test Day 8. The body weights were considered unremarkable for the remainder of the post-exposure period.

Gross pathology:

Gross postmortem findings occurred sporadically and were not considered related to the test material.

Other findings:

Not relevant

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

A single four-hour exposure to 6.3 mg/l Santicizer 148 as a respirable aerosol mixture produced no mortality in a group of 10 rats. Signs exhibited during exposure included increases in secretory responses and reduced activity. Signs during the post-exposure period: incidences of secretory responses, rough coat and yellow ano-genital fur. A transient decrease in body weight was observed. As no deaths occurred the tested concentration can be considered as LC0. Based on these results, the test substance does not need to be classified for acute inhalation toxicity according to the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.

Executive summary:

This acute inhalation toxicity study in rats was conducted according to a method resembling OECD guideline 403. A single 4-hour exposure to 6.3 mg/l Santicizer 148 as a respirable aerosol mixture produced no mortality in a group of 5 male and 5 female Sprague-Dawley rats. Rats were observed for 14 days after exposure. Signs exhibited during exposure included increases in secretory responses and reduced activity. Incidences of secretory responses, rough coat and yellow ano-genital fur persisted during the two-week post-exposure period. A transient decrease in body weight was noted an Test Day 2. Subsequently, female body weights were unremarkable, while all males did not regain their pretest body weights until Test Day 8. Gross postmortem findings occurred sporadically and were not considered related to the test material. As no deaths occurred the tested concentration can be considered as LC0. Based on these results, the test substance does not need to be classified for acute inhalation toxicity according to the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.