Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study. Meets generally accepted scientific standards, well documented and acceptable for assessment. No Purity of test substance available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

observation period 7 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

EC Number:

265-512-0

EC Name:

Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

Cas Number:

65140-91-2

Molecular formula:

C17 H29 O4 P. 1/2Ca

IUPAC Name:

calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

Test animals

Species:

rat

Strain:

other: Tif. RAI (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy breeding unit
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160-180 g
- Fasting period before study: one night before treatment
- Housing: 5 per cage in Macrolon cages (Type 3)
- Diet: NAFAG, Gossau SG, rat food, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): ca. 50

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on oral exposure:

DOSAGE PREPARATION:
The test substance was weighed into an Erlenmeyer flask on a Mettler balance and suspended with carboxymethylcellulose 2 %. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

VEHICLE
- Concentration in vehicle: 10% (1000 mg/kg bw) and 30% (other doses)

Doses:

1000, 2150, 3590, 4640, 6000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals recovered within 6 days.

Gross pathology:

No substance related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute oral LD50 of the test article in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.

Executive summary:

In an oral toxicity study performed similarly to the protocol outlined in OECD guideline 401, groups of 5 rats per sex were treated once by gavage with the test article suspended in 2% carboxymethyl cellulose followed by a seven day observation period. The doses administered were 1000, 2150, 3590, 4640 and 6000 mg/kg body weight. All animals survived the procedure. Within 2 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals recovered within 6 days. No substance related gross organ changes were observed. Under the conditions of this study, the LD50 is greater than 6000 mg/kg body weight in male and female rats when applied orally.