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Diss Factsheets

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

A chronic oral feeding study is available, indicating no carcinogenic potential of Benzoguanamine in mice and rats.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information on the Guideline or GLP status of the study is not available, the documentation is insufficient. The study is rated with Klimisch 2 by a national competent authoritiies, therefore this rating is adopted.
Principles of method if other than guideline:
Substance was tested for long-term toxicity by dietary administration to male rats and male and female mice.
GLP compliance:
no
Species:
mouse
Strain:
CD-1
Sex:
male/female
Route of administration:
oral: feed
Duration of treatment / exposure:
18 month
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:
2000 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
4000 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
25
Control animals:
yes
Observations and examinations performed and frequency:
Post-exposure period: 4, 6 month
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
Result (carcinogenicity): negative
Relevance of carcinogenic effects / potential:
This substance did not cause a significant number of tumors.
Dose descriptor:
NOAEL
Effect level:
4 000 ppm
Based on:
test mat.
Sex:
male/female
Remarks on result:
other: Effect type: carcinogenicity (migrated information)
Dose descriptor:
NOAEL
Effect level:
600 mg/kg bw/day
Sex:
male/female
Remarks on result:
other: Effect type: carcinogenicity (migrated information)
This test substance had no significant effects 
on survival and weight gain and did not cause a significant number of
tumors not observed in control mice or  significantly earlier  tumors 
than those occuring spontanously.

- tumor found data in male and female mice
Dose                     High dose   Low dose     Control
-                      (4000 mg/kg) (2000 mg/kg) (pooled)
Sex                     male female male  female   m  f
Initial No               25    25    25    25      150
Early death               9     4    11     4      51 48
Mice with tumor           9     9     3     8      53 76
Mice with Multiple tumors 3     5     1     3      14 21
Tumor found              12    15     4    11      72 99
Lung                                               24 32
-Adenoma                  7     3     2     2
Liver
-Hepatoma                 2     1                   7  1
-Hemangioma                           1
Spleen and uterus
-Hemangiosarcoma                      1
Stomach
-Squamous papilloma             3
-Adenocarcinoma           1*    1     1     1
kidny and ovary
-Hemangiosarcoma                1
Breast (mammary for female)                            7
-Adenocarcinoma                 1**
-Adenoacanthoma                 1
Uterus
-Adenocarcinoma                 1***
-Leiomyoma                      1           1
-Hemangioma                     1           2
Adrenal
-Cortical adenoma         1                 1
Lymphosarcoma             1
Lymphosarcoma of thymus         1
Lymphocytic leukemia                  1     2      17 32
Vascular tumor                                      5  9
Others in Control                                  19 18
*   metastatic to liver and bowel
**  metastatic to lung
*** metastatic to lymph node

This substance had no significant effects on survival and body weight  gain, 
and did not cause a  significant number of tumors including mammary  tumors and
bladder tumors.
Conclusions:
The substance can be considerd as non carcinogenic,. because no carcinnogenic effects were observed.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
600 mg/kg bw/day
Study duration:
chronic
Species:
mouse
Quality of whole database:
Only one study with insufficent documentation is available.

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

For carcinogenicity Benzoguanamine is not classified in accordance to Directive 67/548/EEC, respectively Regulation (EC) No 1272/2008.

Additional information

The available study was rated with Klimisch 2 because only parts of the study report were present. Only the results and a summary are present. As the study was conducted within a national research program it is assumed that the study is valid and leads to conclusive results. National competent authorities rated this study with Klimisch 2.

Therefore, it can be derived, that the substance Benzoguanamine indicates no carcinogenic potential in mice and rates.


Justification for selection of carcinogenicity via oral route endpoint:
The two study summaries rever to the same study where two test species were used. The results in mice are chosen because both sexes are covered.