Registration Dossier
Registration Dossier
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EC number: 203-004-2 | CAS number: 102-08-9
Toxicological information
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- This study was carried out a long time ago so there was a lack of information concerning the test conditions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Tolerance of diphenylthiourea in long-term feeding tests in rats.
- Author:
- Mohr H.J., Nothdurft H.
- Year:
- 1 967
- Bibliographic source:
- Int Archiv für Gewerbepathologie und Gewerbehygiene, 1967; 23: 168-174.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Testing for carcinogenic effect after 2 years' feeding. Lifespans of animals and times to appearance of individual tumours are observed.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3-diphenyl-2-thiourea
- EC Number:
- 203-004-2
- EC Name:
- 1,3-diphenyl-2-thiourea
- Cas Number:
- 102-08-9
- Molecular formula:
- C13H12N2S
- IUPAC Name:
- 1,3-diphenyl-2-thiourea
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- by feeding for life-time with a diet containing 1000 ppm of test substance.
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
Doses / concentrations
- Dose / conc.:
- 1 000 ppm (nominal)
- No. of animals per sex per dose:
- test group: 79 females + 81 males
control group: 101 females + 99 males - Control animals:
- yes
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- - Clinical signs were observed: malign and benign tumours
- Mortality: yes - Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Result (carcinogenicity): negative. No significant results were observed in this study.
AMONG THE FEMALES:
- In the treated group:
. 1 mammary fibroadenoma appeared between the 16th and 18th months of the trial,
. 2 mammary fibroadenomas and 1 spindle-cell sarcoma between the 19th and 21st months.
Between the 16th and 18th months, the half of the animals was dead and at the end of the trial only 1 animal was still living.
- In the control group:
. 1 mammary fibroadenoma and 1 fibrosarcoma appeared between the 19th and 21st months,
. 1 intraperitoneal sarcoma between the 22nd and 24th months,
. 3 mammary fibroadenomas and 1 uterine adenocarcinoma between the 25th and 27th months,
. 3 mammary fibroadenomas between the 28th and 30th months,
. 1 mammary fibroadenoma and 1 uterine sarcoma from the 31st month of the trial.
As in the treated group, between the 16th and 18th months, the half of the animals was dead and at the end of the trial only 1 animal was still living.
AMONG THE MALES:
- In the treated group:
. 1 bladder wall adenocarcinoma was observed between the 13th and 15th months,
. 1 lipoma between the 16th and 18th months,
. and 1 haemangio-endothelioma from the 31st month of the trial. Between the 13th and 15th months, the half of the animals was dead and no surviving animals was found at the end of the trial.
- In the control group:
. 1 lymphosarcoma was detected between the 13th and 15th months,
. and 1 fibrosarcoma between the 28th and 30th months of the trial. No surviving animals was found too at the end of the trial.
=> No rise in specific tumours and so no carcinogenic effects was observed in treated animals compared to controls.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- carcinogenicity
- Effect level:
- > 1 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
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