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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral
Remarks:
combined repeated dose and carcinogenicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline followed
Principles of method if other than guideline:
EPA Pesticide Assessment Guidelines - Subdivisions F, hazard Evaluation - Human and Domestic Animals - Revised edition. U.S. Environmental Protection Agency, Washington D.C., 1984
GLP compliance:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
A vizsgálathoz szükséges SPF Wistar törzsű hím és nőstény állatokat a LATI Közös Vállalatól szerezték be 4 hetes korban. A vizsgálatot 6 hetes állatokon kezdték el.
Az állatokat klimatizált, jól szellőztetett állatszobában, II. típ. állattartó edényben helyezték el, száraz, vegyes faforgács almon. Az állatházban fényprogram alapján 12-12 órás megvilágítást, illetve sötétséget, 21 +- 2 C hőmérsékletet biztosítottak. A légtér relatív páratartalma legalább 40-50% volt.
A viszgálatba vont állatok standard LATI patkánytápt és csapvizet ad libitum fogyasztottak.
Route of administration:
oral: feed
Vehicle:
not specified
Details on oral exposure:
0,19,41,75 mg/ 100 g feed
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Packard 419 type Gas chromatography was used for analytical verification.
Hőmérséklet inj: 190 C
kolonna: 165 C
detektor: 220 C
töltet: 10% SE-52 Chromosorb WAW DMCS 80-100 mesh
oszlophossz: 1m, belső átmérő: 2mm
vivőgáz: nitrogén, hidrogén és levegő mennyisége, detektor optimum szerint
Duration of treatment / exposure:
18 months
Frequency of treatment:
0,19,41,75 mg/ 100 g feed
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
10 mg/kg bw/day (actual dose received)
Dose / conc.:
21 mg/kg bw/day (actual dose received)
Dose / conc.:
39 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
15 male and 15 female
Control animals:
yes
Observations and examinations performed and frequency:
szemvizsgálat, túlélés, viselkedés, testtömeg és takarmány/víz-fogyasztás, vizeletvizsgálat, hematológiai vizsgálat, klinikai kémiai vizsgálatok, kórbonctani vizsgálat, szervtömeg mérés, kórszövettani vizsgálat,
Sacrifice and pathology:
Kóronctani vizsgálat: minden állatot (CO2-vel történt túlaltatás után) feldolgoztak. A makroszkópikus megfigyelés kiterjedt az általános erőnléti állapotra, testnyílásokra, a kültakaróra és a belső szervekre. Az esetleges elváltozásokat feljegyezték.
Statistics:
Az egyes dóziscsoportban számított, mért adatok kontrolltól való eltérésének statisztikai ellenőrzésére a Student-féle t-próbát alkalmaztuk. A varinacia homogenitás vizsgálatára a Bartlett próbát vettük igénybe.
Clinical signs:
no effects observed
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
NOEL no toxic effect level: female 21 mg/kg bw/day
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Description (incidence and severity):
az elváltozások nem hozhatók összefüggésbe a viszgálati anyag toxikus hatásával
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 21 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Effect: body weight changes
Key result
Dose descriptor:
NOEL
Remarks:
highest dose examined
Effect level:
ca. 39 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: no significant effect for male rats
Key result
Critical effects observed:
yes
Lowest effective dose / conc.:
39 mg/kg bw/day (actual dose received)
System:
other: body weight
Organ:
not specified
Treatment related:
yes
Dose response relationship:
yes
Relevant for humans:
yes
Conclusions:
The NOAEL is 21 mg/kg bw/day ( repeated dose toxicity female rat)
The NOEL is 39 mg/kg bw/day ( repeated dose toxicity male rat)
Executive summary:

The NOAEL is 21 mg/kg bw/day ( repeated dose toxicity female rat)

The NOEL is 39 mg/kg bw/day ( repeated dose toxicity male rat)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
21 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
reliable very well documented

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity: via oral route - systemic effects (target organ) other: all gross lesions and masses

Justification for classification or non-classification