O,O'-dioctadecylpentaerythritol bis(phosphite)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

10 November 1977 to 24 November 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

(exposure duration 1 hour rather than 4 hours)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

EC Number:

223-276-6

EC Name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

Cas Number:

3806-34-6

Molecular formula:

C41H82O6P2

IUPAC Name:

3,9-bis(octadecyloxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 225 g (average)
- Housing: individually
- Diet: ad libitum (except during exposure period)
- Water: ad libitum (except during exposure period)
- Acclimation period: 3 days

IN-LIFE DATES: From 10 November 1977 to 24 November 1977

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: specially constructed, all plexiglas inhalation chambers
- Exposure chamber volume: 355 cubic litres
- Method of holding animals in test chamber: Each animal was placed in a separate wire cage during exposure to prevent filtration of inspired air by animals fur
- System of generating test atmosphere: The chamber was equipped with blowers so that after the test material was introduced into the chamber's atmosphere the air was continually recirculating during the test period

TEST ATMOSPHERE
The average nominal test material concentration was calculated by dividing the total amount of test material used by the total volume of the chamber

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Concentrations:

2 mg/L

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: all animals were weighed at study initiation and then again on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: a gross pathological autopsy was conducted on all animals found dead during the study as well as on all surviving animals

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

None of the animals died during the study.

Clinical signs:

other: All animals appeared normal during the 14 day period.

Body weight:

All of the animals gained weight during the study.

Gross pathology:

The organs of the thorax and abdomen appeared normal at gross pathology.

Any other information on results incl. tables

Table 1: Results

Animal no. and sex	Initial bodyweight (g)	Dose (mg/L)	Weight gain in 14 days (g)	Days to death
1F	204	2	46	survived
2F	201	2	78	survived
3F	210	2	60	survived
4F	202	2	70	survived
5F	206	2	60	survived
6M	228	2	102	survived
7M	242	2	106	survived
8M	232	2	130	survived
9M	236	2	112	survived
10M	254	2	136	survived

Applicant's summary and conclusion

Interpretation of results:

other: LC50 in excess of 2 mg/L (1 h) (highest dose level tested), the classification of the test material cannot be interpreted based on the results of the study

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 was determined to be greater than 2 mg/L of atmosphere for a one hour exposure period to the test material.

Executive summary:

The acute inhalation toxicity of the test material was determined following a methodology similar to that outlined in the standard guideline OECD 403. During the study, 5 male and 5 female rats were exposed to atmospheres containing test material at 2 mg/L for 1 hour. During the exposure period, mortality and signs of reaction to the test material were assessed. Following exposure the animals were returned to their cages where they were observed for 14 days. At the end of the 14 day exposure period all animals were subject to a gross pathological examination.

Under the conditions of the study, none of the animals died. All animals appeared normal during the 14 day observation period and gross necropsy revealed that the organs of the thorax and abdomen appeared normal. The acute inhalation LC50 was therefore determined to be greater than 2 mg/L of atmosphere for a one hour exposure period to the test material.