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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1989

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
S-ethyl N-cyclohexylthiocarbamate
EC Number:
214-482-7
EC Name:
S-ethyl N-cyclohexylthiocarbamate
Cas Number:
1134-23-2
Molecular formula:
C11H21NOS
IUPAC Name:
S-ethyl N-cyclohexylthiocarbamate
Details on test material:
97.6% cikloát

Test animals

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.

Administration / exposure

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
Doses / concentrationsopen allclose all
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

Examinations

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.

Results and discussion

Results of examinations

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

Effect levels

open allclose all
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

Target system / organ toxicity

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

Applicant's summary and conclusion

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)