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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:
9. Oct 27. Oct 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphoric acid, butyl ester
EC Number:
235-826-2
EC Name:
Phosphoric acid, butyl ester
Cas Number:
12788-93-1
Molecular formula:
C4H11PO4
IUPAC Name:
Phosphoric acid, butyl ester
Test material form:
other: liquid
Details on test material:
pH < 3
clear liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: 123.2 g
- Fasting period before study: 16 h
- Housing: in Macolon cages type III (in groups of 1-5 animals)
- Diet (e.g. ad libitum): R10 Alleindiät für Ratten, Ssniff Spezialfutter, Soest, Germany, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.10. To: 27.10.1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: undiluted
- Amount of vehicle (if gavage):3.522 - 5.584 mL/kg


MAXIMUM DOSE VOLUME APPLIED: 5.584 mL/kg


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: dose setting based on results of pre-study
Doses:
3980, 5010 or 6310 mg/kg bw/d
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: Clinical observations daily after application / Weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
LD50 determination according to Litschfield and Wilcoxon

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 300 mg/kg bw
95% CL:
> 4 609 - <= 6 095
Mortality:
Dose: 3980 mg/kg bw, Mortality rate: 1 / 5 (males), 0/5 (females)
Dose: 5010 mg/kg bw, Mortality rate: 5 / 5 (males), 1/5 (females)
Dose: 6310 mg/kg bw, Mortality rate: 3 / 5 (males), 3/5 (females)
Clinical signs:
other: closed eye lid, abnormal breathing, crouched posture, piloerection, decreased motor acivity all signs were reversible within 48 h
Gross pathology:
thickening/necosis of intestinal and stomach mucosa
necrotic foci in liver, kidneys, spleen, pancreas and testis (sporadically)

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 Phosphoric acid, butyl ester was 5300 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:

Phosphoric acid, butyl ester was tested for its acute oral toxicity potential. 5 male and 5 female rats were treated with doses of 3980, 5010 or 63100 mg/kg bw and observed for 14 days.

The median lethal dose of Phosphoric acid, butyl ester (LD50) was 5300 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.

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