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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD guideline for testing of chemicals, No. 407.
Deviations:
yes
Remarks:
modified for intravenous application.
Principles of method if other than guideline:
Repeated dose intravenous toxicity.
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Details on test material:
IPS Empress 2, group 1 frits. Group 1 frits are double-fired zirconium white, without Zn, Pb or Ba.

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEK 7012 rodent diet (Harlan) and tap water available ad lib. Age at study initiation >34 days. Weight range 20.3-22.9g. Temperature 20 +- 5˚C, 30-70% relative humidity, 12 h dark/12 h light cycle.

Administration / exposure

Route of administration:
intravenous
Vehicle:
other: 0.9% NaCl solution
Details on exposure:
Two weeks of daily (5 days/week) intravenous injections of test extract.
Duration of treatment / exposure:
Two weeks.
Frequency of treatment:
Daily (5 days/week)
Doses / concentrations
Remarks:
Doses / Concentrations:
25 ml/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
Only limit test with prepared extract.

Examinations

Observations and examinations performed and frequency:
Clinicals signs were observed daily. Body weights were measured on days 0, 7 and 14. Haematology, prior to necropsy.
Sacrifice and pathology:
Necropsy day 14. Gross necropsy: examination of external body surfaces, all orifices, cranial/thoracic and abdominal cavities and their contents. Organs were preserved and liver, kidneys/adrenals (combined) and gonad weights were determined.
Other examinations:
Not applicable
Statistics:
Not applicable

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
At necropsy, histopathology revealed slight subacute hepatitis, slight fatty infiltration in the heart and slight nephropathy in animals from all groups (including controls); this was not considered relevant by the study author.

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 25 other: NaCl extract of test frit/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: greater than or equal to 25 ml NaCl extract of test frit/kg bw/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL for IPS Empress 2 frit (Group 1 ceramic frits) in mice is greater than or equal to 25 ml NaCl extract of test frit/kg bw/day.
Executive summary:

The NOAEL for IPS Empress 2 frit (group 1(exempt) ceramic frit) in mice is greater than or equal to 25 ml NaCl extract of test frit/kg bw/day. This study (Krenzer, 2004) is considered reliable (2). It is a GLP compliant, guideline study with minor restrictions in design and/or reporting, but it is otherwise adequate for assessment.