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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, similar to guideline study, available as unpublished report, minor restrictions in design and/or reporting buth otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
According to BASF-internal method: Five Wistar rats per sex per dose were exposed once by oral gavage to the test substance in 5% aquaous CMC solution. After an observation period of 14 days, animals were necropsied.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(diethoxyphosphinyl)-2-methyl-2-butenoic acid ethyl ester
EC Number:
601-818-6
Cas Number:
122009-11-4
Molecular formula:
C11 H21 O5 P
IUPAC Name:
4-(diethoxyphosphinyl)-2-methyl-2-butenoic acid ethyl ester
Details on test material:
- Name of test material (as cited in study report): C-5-Ester-phosphonat Techn.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG (Germany)
- Weight at study initiation: Initial mean body weight was 180 g for the males and 179 g for the females
- Fasting period before study: 16 hours (water remained available ad libitum)
- Housing: five per cage in stainless steel wire mesh cages, Type DK-III (Becker&Co, Castrop-Rauxel, Freiburg, Germany)
- Diet: standard diet (Kliba-labordiaet 343), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% aqueous
Details on oral exposure:
VEHICLE
- Concentration in vehicle: the test substance was emulsified in 0.5% aqueous carboxymethylcellulose to a final concentration of 20% (w/v) and administered by gavage.
- Amount of vehicle (if gavage): 10 mL/kg bw
Doses:
2000 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 and weighing: recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes; withdrawal of food about 16 hours before sacrifice with CO2, then necropsy at the end of the observation period, or necropsy of all animals that died as soon as possible. All animals were subjected to gross-pathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed in all exposed animals.
Clinical signs:
other: Dyspnea, apathy, staggering, salivation, and poor general state were observed in both males and females. In females, abnormal position, atonia, and paresis were observed additionally. Symptoms were observed as early as 15 minutes after dosing. Animals wer
Gross pathology:
No pathological findings were observed.

Any other information on results incl. tables

Table 1: Body weight 

Time period
Mean body weight for males
Mean body weight for females
At test begin
180 g
179 g
After 7 days
243 g
215 g
After 10 days
259 g
221 g

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this test, the LD50 was determined to be >2000 mg/kg bw.
Executive summary:

Five Wistar rats per sex were exposed to 2000 mg/kg bw of the test substance dissolved in 0.5% aqueous carboxymethyl cellulose solution, via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Several clinical signs were observed such as dyspnea, apathy, staggering, salivation, abnormal position, atonia, paresis, and a poor general state. No pathological effects and no mortality were observed. The LD50 was therefore determined to be >2000 mg/kg bw.