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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline study, some restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

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:
Five male and five female animals were used for each of 5 oral dosage levels and held for a 14-day observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Aluminum potassium fluoride
EC Number:
262-153-1
EC Name:
Aluminum potassium fluoride
Cas Number:
60304-36-1
Details on test material:
Nocolok 100 FLUX (AT-1-KC)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Madison WI
- Age at study initiation: 7 weeks
- Weight at study initiation: 202-300 g
- Fasting period before study: overnight
- Housing: 5/cage
- Diet: ad libitum, Purina Rodent Chow
- Water: ad libitum
- Acclimation period: 7 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10.0 ml/kg bw
Doses:
Males: 2.55, 2.75, 3.00, 3.57, 5.00 g/kg
Females: 1.30, 1.82, 2.55, 3.57, 5.00 g/kg
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 signs and mortality: 1, 2.5 and 4 hrs after administration and daily thereafter. Weighing: before administration and on day 7 and 14
- Gross necropsy of animals which died: yes
- Gross necropsy of survivors performed: no
Statistics:
Thakur, A.K., and Fezio, W.L., 1891. A computer program for estimating LD50 and its confidence limits using a modified Behrens-Reed-Muench cumulant method. Drug and Chemical Toxicology, 297-305.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2.72 other: g/kg bw
95% CL:
2.52 - 2.93
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2.15 other: g/kg bw
95% CL:
1.61 - 2.89
Mortality:
Males: 2.55 g/kg: 0/5 (0 of 5 animals); 2.75 g/kg: 3/5; 3.57-5.00 g/kg: 5/5
Females: 1.30 g/kg: 0/5; 1.82 g/kg: 2/5; 2.55 g/kg: 3/5; 3.57-5.00 g/kg: 5/5
Clinical signs:
other: not reported
Gross pathology:
In the animals which died histopathological lesions were observed mainly in the gastro-intestinal tract, primarily in the stomach.

Applicant's summary and conclusion