3-hydroxypropiononitrile

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Chronic effects of oral ethylene cyanohydrin on male rats and mice.

Author:

Hirose M, Fukushima S, Shibata M, Ito N Nagoya|

Year:

1980

Bibliographic source:

Medical Journal 25: 1-2

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guideline for Carcinogen Bioassay in Small Rodents

Principles of method if other than guideline:

Method: other: in accordance with Sontag, J.M. et al., Guidelines for Carcinogen Bioassay in Small Rodents. National Cancer Institute Carcinogenesis Technical Report Series No.1, 16-22

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxypropiononitrile

EC Number:

203-704-8

EC Name:

3-hydroxypropiononitrile

Cas Number:

109-78-4

Molecular formula:

C3H5NO

IUPAC Name:

3-hydroxypropanenitrile

Details on test material:

Name of test material (as cited in study report): Ethylene cyanohydrin
- Substance type: aliphatic nitrile
- Physical state: colourlesss liquid
- Analytical purity: commercial product (Tokyo Kasei co., Tokyo, Japan)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

78 weeks

Frequency of treatment:

continuously in diet

Post exposure period:

no data

Doses / concentrations

Remarks:

Doses / Concentrations:
0; 100; 1000 and 3000 ppm (0; 5; 50 and 150 mg/kg bw/day)
Basis:
nominal in diet

No. of animals per sex per dose:

43 male rats for each dose, 31 male rats for the control

Control animals:

yes

Details on study design:

Post-exposure period: no

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:

Ethylene cyanohydrin did not induce a significantly higher number of tumors in the animals of the groups 1-3 in comparison with the control group.

Any other information on results incl. tables

Table 1. Changes in Body, Liver, Kidney and spleen weights in male rats treated with Ethylene cyanohydrin for 78 weeks.   group  dose (ppm)  effective number*  of rats  bw(g); initial  bw(g); final  liver (g)%/bw  kidney (l);  (g)% /bw  kidney (r); (g)% /bw  spleen (g) %/bw    1  3.000  20  150.4  486.3  11.1(2.3)  1.8 (0.4)  1.7(0.3)  1.4(0.3)    2  1.000  29  148.7  507.5  10.6(2.1)  1.7(0.3)  1.7 (0.3)  1.4(0.3)    3  100  22  148.6  504.0  11.0(2.2)  1.9(0.4)  1.8 (0.4)  1.3(0.3)    4  0  15  148.0  562.0  10.1(1.8)  1.7(0.3)  1.7 (0.3)  1.0(0.2)    *Rats that survived more than 60 weeks.

Table 2. Mean Hematological and Blood Biochemical Values of male Rats, treated with Ethylene cyanohdrin for 78 weeks  group  dose  (ppm)  Number* of rats  RBC (x 10²/mm³)  WBC (x 10²/mm³)  Hb (mg/dl)  Ht (%)  SGOP (K units)  SAP (KA units)  SGPT (k units)  Glucose (mg/dl)  TP (g/dl)  BUN (mg/dl)  1  3.000  19  624  78  11.8  41.0  130  14.5  30  68  6.9  20  2  1.000  24  713  86  13.8  43.6  128  14.3  30  73  6.5  13  3  100  20  704  98  13.8  45.5  130  14.8  22  75  6.9  18  4  0  13  727  103  14.0  49.0  127  11,7  23  74  6.4  19  *Rats that survived for 78 weeks.

Whiteand red celll counts (WBC, RBXC); hemoglobin concentration (Hb); hematocrit values (Ht); Serum total protein (TOP); alkaline phosphatase (SAP); blood urea nitrogen (BUN), glutamic-oxaloacetic transaminase (SGOT);  glutamic-pyruvic transaminase (SGPT). Table 3. Incidence of tumor (values in prarantheses in percentages)** in a male rats treated with Ethylenecyanohydrin for 78 weeks  group  dose (ppm)  Number*  of rats ** pituitary adenoma ** adrenal adenoma  ** subcutaneous   fibroma **lung adenona **liver: nodular hyperplasia ** liver:  hepatoma **  leukemia    1  3.000  20  0 (-)  2 (10.0)  0 (-)  0 (-) 0 (-)  0 (-)  1(5.0)    2  1.000  29  1(3.4)  2 (6.9)  0 (-)  0 (-)  0 (-)  0 (-)  1 (3.4)    3  100  22  1(5.0)  1(5.0)  1(5.0)  0 (-)  0 (-)  0 (-)  0 (-)    4  0  15  0 (-)  1 (6.7)  0 (-)  0 (-)  0 (-)  0 (-)  0 (-)                          *Rats that survived more than 60 weeks.

Applicant's summary and conclusion

Conclusions:

Ethylene cyanohydrin is not carcinogenic to rats when given orally at concentrations of <= 3000 ppm.