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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From June 02, 1987 to June 17, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium hexadecyl hydrogen phosphate
EC Number:
242-768-1
EC Name:
Potassium hexadecyl hydrogen phosphate
Cas Number:
19035-79-1
Molecular formula:
C16H35O4P.K
IUPAC Name:
Potassium hexadecyl hydrogen phosphate
Constituent 2
Chemical structure
Reference substance name:
Dihexadecyl hydrogen phosphate
EC Number:
218-594-7
EC Name:
Dihexadecyl hydrogen phosphate
Cas Number:
2197-63-9
Molecular formula:
C32H67O4P
IUPAC Name:
bis(hexadecyloxy)phosphinic acid
Constituent 3
Chemical structure
Reference substance name:
Hexadecan-1-ol
EC Number:
253-149-0
EC Name:
Hexadecan-1-ol
Cas Number:
36653-82-4
Molecular formula:
C16H34O
IUPAC Name:
Hexadecan-1-ol
Constituent 4
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
Test material form:
solid

Test animals

Species:
rat
Strain:
other: Ibm: RORO (SPF), also known as Fü-albino SPF rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals
- Age at study initiation: about 6 weeks
- Weight at study initiation: female 114-117 g; male 116-124 g
- Fasting period before study: 18 h
- Housing:
- Diet: NAFAG standard rat maintenance diet, No. 850 (cubic), ad libitum
- Water: tap water, ad libitum
- Acclimatisation period: seven days under laboratory conditions

Environmental conditions
- Temperature: 20-24°C
- Humidity: 45-65 %
- Air changes: air-conditioned room
- Photoperiod: 12/12 h dark / light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Standard Suspending Vehicle (SSV), please see below in " Details on oral exposure"
Details on oral exposure:
Vehicle
The test article was suspended in Standard Suspending Vehicle (SSV)
1000 mL SSV contain:
5 g sodium carboxy methyl cellulose of median viscosity,
4 mL Tween 80,
5 mL benzylalcohol pro analysis,
9 g sodium-chloride pro analysis,
aqua destillata ad 1000 mL.

- Amount of vehicle: 10 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 d
- Frequency of observations and weighing: daily for clinical signs and weighing on Day 1, 4, 8, 11, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (respiratory distress, crust around nose, hunched posture, crust around eyes, exitability), body weight, histopathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: i.e., equivalent to >4250 mg a.i./kg bw
Mortality:
No compound-related deaths occurred.
One male was found dead early in the morning of Day 8. This case of death was considered to be a result of an application injury. This male rat showed a marked respiratory distress and a marked loss of weight. The histopathological examination of the lung of this animal revealed aspiration pneumonia.
Clinical signs:
other: The main symptom was respiratory distress seen in 3 males and 1 female. This symptom developed in consequence of aspiration of a little test suspension. The other findings were of no toxicological significance.
Gross pathology:
In the urinary bladder of male rat 2694, gritty contents were observed. This finding was of a spontaneous nature. No other macroscopic organ changes were seen.
Other findings:
Histopathology: Bronchopneumonia caused the respiratory distress and itself was caused by aspiration of test suspension (by the male rat that died at Day 8).

Applicant's summary and conclusion

Interpretation of results:
other: not classified based on EU CLP Criteria
Conclusions:
Under the study conditions, the LD50 for the test substance was determined to be >4250 mg a.i./kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, mono- and di- C16 PSE, K+ (purity: ca. 85%), according to the OECD Guideline 401, standard acute method, in compliance with GLP. Five male and 5 female Fü-albino SPF rats were randomly selected for an acute oral toxicity study. Fasted rats were given a single dose of the test substance suspended in SSV (Standard Suspended Vehicle) by gavage at a dose level of 5000 mg/kg bw. They were observed for 15 d for toxic signs, mortality and body weight changes. All rats were examined for gross lesions. No compound-related deaths occurred. No compound-related incompatibility reactions were observed. No compound-related effect on body weight development appeared. No compound-related gross or microscopic lesions were observed. Under the study conditions, the LD50 for the test substance was determined to be >5000 mg/kg bw (i.e., equivalent to >4250 mg a.i./kg bw) (XXXX, 1987).