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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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.