Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Apr 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study design equivalent to OECD 401 with sufficient reporting

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
performed before GLP guidelines
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 160-180 g (female); (mean = 168.9 g; s = ± 5.99; n = 50)
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Housing: in groups, in plastic cages, wood shavings

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (w/v)
Doses:
630 mg/kg bw
1250 mg/kg bw
1800 mg/kg bw
2500 mg/kg bw
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
Probit analysis (method by Linder and Weber);
Confidence limits according to Fieller

Results and discussion

Preliminary study:
Preliminary experiments showed higher sensitiveness for females. Therefore only females were used for the main study.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 010 mg/kg bw
95% CL:
> 1 510 - < 2 790
Mortality:
Sex: female, Dose: 630 mg/kg bw, Mortality rate: 1 / 10
Sex: female, Dose: 1250 mg/kg bw, Mortality rate: 2 / 10
Sex: female, Dose: 1800 mg/kg bw, Mortality rate: 3 / 10
Sex: female, Dose: 2500 mg/kg bw, Mortality rate: 6 / 10
Sex: female, Dose: 5000 mg/kg bw, Mortality rate: 10 / 10
Clinical signs:
Mortally poisened animals died within 2 h -4 days after application.
Following symptoms were observed: abnormal breathing, crouched posture
Surviving animals showed no symptoms.
Body weight:
- normal body weight gain in all surviving animals
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings.
Necropsy of the deceased animals revealed following macroscopic findings: red spots in the lungs, gastro-intestinal tract injected with blood vessels, red secretion from eyes and nose

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of Reaction mass of potassium ethyl octylphosphonate and diethyl octylphoshonate was 2010 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.
Executive summary:

Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its acute oral toxicity potential. 10 female rats were treated with doses of 630, 1250, 1800, 2500 or 5000 mg/kg bw and observed for 14 days.

The median lethal dose of Reaction mass of ethyl octylphosphonate and diethyl octylphosphonate (LD50) was 2010 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.