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

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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:

1983

Report date:

1983

Materials and methods

Principles of method if other than guideline:

Five male and female rats were dosed with 200, 500, and 1000 mg/kg bw, by intraperitoneal injection. The animals were observed for at least 14 days following administration, or until all symptoms had disappeared. Mortality was observed daily, a.m. and p.m. on working days. Signs and symptoms were observed daily, and body weight was determined on days 1, 7, 14 and at death. Necropsy of survivors was performed at the end of the observation period. Spontaneously dying animals were submitted to a gross necropsy as soon as possible.

GLP compliance:

no

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]

Details on test material:

- Physical state: solid

Test animals

Species:

rat

Strain:

other: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 185-259 g
- Fasting period before study: one night before treatment
- Housing: 5 per cage in Macrolon cages (Type 3)
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum.
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): ca. 55+/-15
- Air changes (per hr): ca. 15
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Doses:

200, 500, and 1000 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 or until all symptoms have disappeared
- Mortality observations: daily, a.m. and p.m. on working days
- Signs and symptoms: daily
- Body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes, spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated. When feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

595 mg/kg bw

Based on:

test mat.

95% CL:

301 - 2 100

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 735 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 662 mg/kg bw

Based on:

test mat.

Mortality:

200 mg/kg bw: 0/5 (male), 0/5 (female)
500 mg/kg bw: 2/5 (male), 2/5 (female)
1000 mg/kg bw: 4/5 (male), 3/5 (female)
The animals died between 2-3 hours after administration of test substance.

Clinical signs:

200 mg/kg bw: Dyspnoea, exophthalmus, ruffled fur, and curved body position.
500 mg/kg bw: Dyspnoea, exophthalmus, ruffled fur, and curved body position.
1000 mg/kg bw: Dyspnoea, exophthalmus, ruffled fur, and lateral and curved body position.
The surviving animals recovered between 9 and 10 days after administration.

Body weight:

For details see table 1 in "Any other information on results"

Gross pathology:

No gross lesions were found at necropsy.

Any other information on results incl. tables

Table 1: Mean body weight of male and female rats at day 1, 7, and 14.

Mean body weight (g) ± sd	200 mg/kg bw	500 mg/kg bw	1000 mg/kg bw
Day 1 male	221±6.2	230±6.3	234±14.7
Day 1 female	198±8.3	195±8.1	199±6.6
Day 7 male	265±3.4	264±16.6
Day 7 female	220±15.5	215V10.7
Day 14 male	311±7.7	307±27.8
Day 14 female	235±14.5	234±10.1