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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: Guideline study described in sufficient detail.

Data source

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

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Potassium tert-butanolate
EC Number:
212-740-3
EC Name:
Potassium tert-butanolate
Cas Number:
865-47-4
IUPAC Name:
potassium 2-methylpropan-2-olate

Test animals

Species:
rat
Strain:
other: Bor:WISW(SPF Cpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen
- Weight at study initiation: 205 g male, 160 g female
- Fasting period before study: 16 h
- Housing: Makrolon Typ III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-8 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5.1-7.94 %
- Amount of vehicle (if gavage): volume 10 cm3/kg
Doses:
510 mg/kg bw
631 mg/kg bw
794 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Statistics:
For body weights mean values were calculated. LD50 were calculated according to Litchfield and Wilcoxon with 95% confidence intervals.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
690 mg/kg bw
Based on:
test mat.
95% CL:
620 - 768
Sex:
male
Dose descriptor:
LD50
Effect level:
715 mg/kg bw
Based on:
test mat.
95% CL:
611 - 837
Sex:
female
Dose descriptor:
LD50
Effect level:
675 mg/kg bw
Based on:
test mat.
95% CL:
587 - 776
Mortality:
794 mg/kg: 7/10 animals died
631 mg/kg: 4/10 animals died
510 mg/kg: 0/10 animals died
Clinical signs:
Animals showed a hunked posture, closed eyes, gasping, oral and nasal bloody discharge, increased repsiratory rate, diarrhea and cachexia, lateral and prone position, sedation and ataxia.
Body weight:
Animals had a reduced body weight compared to the beginning of the study.
Gross pathology:
Dissection showed necrosis in mucosa of gastro-esophagaeal vestibule and in the stomach. Peritoneum had a blue-red colour, abdominal viscus sticked together and a hyperemia of the renal pelvis and of the intestinal mucosa were found. Atrophy was found in the stomach, spleen and mesentary. A thickening of the mucosa of gastro-esophagaeal vestibule and in the stomach was detected.

Applicant's summary and conclusion

Conclusions:
The pathological findings were based on the corrosive properties of the test substance and do not support a classification.