Tris[2-[[2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - April 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

usage of 5 male and 5 females animals

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris[2-[[2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]amine

EC Number:

279-459-6

EC Name:

Tris[2-[[2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]amine

Cas Number:

80410-33-9

Molecular formula:

C90H132NO9P3

IUPAC Name:

2-[(2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl)oxy]-N,N-bis{2-[(2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl)oxy]ethyl}ethanamine

Test material form:

solid

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was suspended to achieve a concentration suitable for the selected dose levels.

FORM AS APPLIED IN THE TEST (if different from that of starting material): suspended in Polyethylene glycol 400 (PEG 400)

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY limited
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: males: 191 g (mean); females: 185 g (mean)
- Fasting period before study: yes, overnight
- Housing: 5 animals/cage
- Diet: NAFAG No. 890 , NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

5000 mg/kg bw

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: 1/2/3/4/5/24 hours after applikation of the test substance and daily thereafter until day 14
- Frequency of weighing: on the day of applikation of the test substance (day 1), day 7 and day 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no mortality observed

Clinical signs:

- sedation (from 1 h until 24 h after treatment)
- slight dyspnoea (from 1 h until day 6 after treatment)
- slight exophthalmos (from 1 h until day 5 after treatment)
- ruffled fur (moderate from 1 h until 24 h after treatment and slight until day 6 after treatment)
- slight diarrhoea (from 5 h until 24 h after treatment)
- slightly curved body position (from 1 h until day 5 after treatment)

Body weight:

no effects observed

Gross pathology:

no effects observed

Any other information on results incl. tables

The animals recovered within 7 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material is therefore practically non toxic to the rat by this route of administration.