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EC number: 200-272-2 | CAS number: 56-40-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
LOAEL (male/female): 1561 mg/kg bw/d
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only two dose levels, limited documentation (clinical signs, gross pathology)
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- The carcinogenicity of glycine was assessed in rats by application in the drinking water.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Co. Japan, Inc. Atsugi
- Age at study initiation: 6 wks
- Housing: in plastic cages (3/sex/cage)
- Diet (ad libitum): pellet diet (CRF-1, Charles River, Japan)
- Water (ad libitum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 55 ± 5 - Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 108 wks
- Frequency of treatment:
- continuously via drinking water
- Dose / conc.:
- 2.5 other: % (nominal in water)
- Remarks:
- equivalent to 1534 mg/kg bw/day for males and 1587 mg/kg bw/day for females (actual ingested)
- Dose / conc.:
- 5 other: % (nominal in water)
- Remarks:
- equivalent to 3280 mg/kg bw/day for males and 3082 mg/kg bw/day for females (actual ingested)
- No. of animals per sex per dose:
- 50
- Control animals:
- other: drinking water without test substance
- Details on study design:
- - Dose selection rationale: on the basis of a preliminary subacute experiment (not further specified)
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: every one or two weeks
FOOD CONSUMPTION: Yes
- Time schedule for examinations: every four weeks
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at week 108
- How many animals: all survivors
- Parameters checked: white/red blood cells, heamoglobin (Hb), haematocrit (Ht)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at week 108
- How many animals: all survivors
- Parameters checked: glutamic oxalacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), creatine phosphokinase (CPK), blood urea nitrogen (BUN), creatinine (CRE), Urea (UA), total protein (TP), albumin/globulin rate (A/G rate), blood glucose (BG), phospholipid (PL), total cholesterol (Tch), triglyceride (TG), natrium, potassium, calcium, chloride
URINALYSIS: Yes
- Parameters checked: leukocytes, nitrite, urobilinogen, protein, pH, ketone, glucose - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (all animals, including those that died or were sacrificed upon becoming moribund during the experiment)
HISTOPATHOLOGY: Yes (all organs were examined and samples were fixed in 10% buffered neutral formalin, embedded in paraffin, and routinely stained with hematoxylin and eosin; histological analysis of tumors in renal pelvis) - Statistics:
- Wilcoxon t-test or chi-squared test
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 5% dose group: slightly increased mortality in females compared to controls
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 5% dose group: slightly increased mortality in females compared to controls
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 2.5 and 5% dose group: slight dose-dependent inhibition of mean body weight gain in both sexes
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 5% dose group: significant changes of Hb and HT in males and females
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 2.5 and 5% dose group, males and females: significantly changes in CPK, BUN, TP, Tch and TG were observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- 2.5 and 5% dose group: papillary necrosis and transitional hyperplasia was observed in male and female animals (no cases seen in the controls)
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- 2.5 and 5% dose group, females: kidney papillomas were seen, which were not observed in controls
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Mortality of females of the high dose group was slightly increased when compared to controls (number of surviving females and males: 31, 46, 41 and 40, 45, 40 for the high, low, control group).
BODY WEIGHT AND WEIGHT GAIN
2.5 and 5% dose group, males and females: Mean body-weights were slightly but dose-dependently inhibited when compared to controls over the hole study period (only growth curves were given).
HAEMATOLOGY
5% dose group, males: A slight but not significant increase in white blood cells was observed. The Hb was significantly increased when compared to controls.
5% dose group, females: A slight but not significant increase in white blood cells and a slight but not significant decrease in red blood cells was observed. The Hb and HT were significantly decreased when compared to controls.
2.5% dose group, females: A slight but not significant increase in white blood cells and a slight but not significant decrease in red blood cells was observed.
CLINICAL CHEMISTRY
2.5 and 5% dose group, males and females: The CPK values were significantly decreased when compared to controls in both sexes and both dose groups. BUN was significantly increased in both sexes of the 5% dose group.
2.5 and 5% dose group, females: A significant and dose-dependent decrease of TP and Tch and a significant and dose-dependent increase in TG was observed.
Some sporadic effects on isolated parameters were observed which were considered as not treatement-related (see Table 1 "Any other information on results incl. tables").
URINALYSIS
No significant differences in urinalysis data between treated and control male and female animals were observed. The only change was increased numbers of erythrocytes in glycine-treated male and female rats. This was expected from haemorrhage in necrotic renal papillae (see histopathology).
ORGAN WEIGHTS
No significant effects on the relative organ weights were observed in the treated groups when compared to controls.
HISTOPATHOLOGY: NON-NEOPLASTIC
The incidences of papillary necrosis in the kidney of male rats fed 2.5 and 5% glycine were 4 and 7%, while the corresponding figures for females were 30 and 32%. Since necrosis of the renal papillae was limited to glycine-treated rats it was very likely linked to the induction of papillomas. Transitional hyperplasia in renal pelvis was observed in 2 female animals of the 2.5% dose group. Calcification indices in kidney were 39, 32 and 42% of the 0, 2.5 and 5% groups. Endometrial polyps in the uterus were increased in both treatment group females (see Table 2/3 "Any other information on results incl. tables").
Overall, for the males, tumors were found in 90% of the high dose group, 97% of the low dose group and in 90% of the controls, while the corresponding figures for females were 59, 65 and 39%. These tumors were considered to be spontaneous in nature (see Table 3 "Any other information on results incl. tables").
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
One renal cell tumor was seen in one male of the high dose group. Renal pelvis papillomas were found in 8% of the low dose group and in 6% of the high dose group females, but not in the controls. Since spontaneous tumors in this tissues are very rare, they were considered as treatment-related (see Table 3 "Any other information on results incl. tables"). - Dose descriptor:
- LOAEL
- Remarks:
- carcinogenicity
- Effect level:
- 1 561 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: histopathology
- Dose descriptor:
- NOAEL
- Remarks:
- carcinogenicity
- Effect level:
- < 1 561 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: histopathology
- Critical effects observed:
- not specified
Reference
Table 1: Clinical chemistry data for rats treated with the test substance (mean values ± standard deviation)
|
Males |
Females |
||||
Group (%) |
0 |
2.5 |
5 |
0 |
2.5 |
5 |
No. of rats |
40 |
45 |
40 |
41 |
46 |
31 |
GOT (K-U) |
122 ± 72 |
120 ± 57 |
114 ± 27 |
130 ± 53 |
117 ± 40 |
136 ± 68 |
GPT (K-U) |
51 ± 34 |
55 ± 37 |
53 ± 12 |
59 ± 22 |
56 ± 12 |
66 ± 16 |
LDH (K-U) |
2879 ± 772 |
2710 ± 972 |
2514 ± 819 |
2572 ± 1369 |
2666 ± 836 |
2556 ± 952 |
ALP (KA-U) |
16 ± 6 |
15 ± 5 |
17 ± 5 |
19 ± 9 |
19 ± 5 |
25 ± 7* |
CPK (IU/L) |
754 ± 321 |
563 ± 217* |
509 ± 197* |
706 ± 392 |
545 ± 160* |
446 ± 158* |
BUN (mg/dL) |
18 ± 3 |
17 ± 2 |
21 ± 3* |
18 ± 2 |
17 ± 2 |
21 ± 3* |
CRE (mg/dL) |
0.6 ± 0.07 |
0.5 ± 0.10* |
0.5 ± 0.11* |
0.5 ± 0.06 |
0.5 ± 0.06 |
0.5 ± 0.07 |
UA (mg/dL) |
2.3 ± 1.5 |
1.9 ± 0.6 |
2.5 ± 1.3 |
2.8 ± 1.8 |
2.0 ± 0.9* |
2.5 ± 1.7 |
TP (g/dL) |
6.9 ± 0.5 |
6.6 ± 0.3* |
6.8 ± 0.4 |
7.5 ± 0.7 |
7.1 ± 0.5* |
6.8 ± 0.7* |
A/G (rate) |
0.6 ± 0.09 |
0.7 ± 0.06* |
0.7 ± 0.06* |
0.8 ± 0.07 |
0.8 ± 0.06 |
0.8 ± 0.09 |
BG (mg/dL) |
131 ± 46 |
127 ± 30 |
140 ± 51 |
136 ± 35 |
127 ± 15 |
125± 27 |
PL (mg/dL) |
216 ± 62 |
205 ± 54 |
214 ± 61 |
211 ± 37 |
205 ± 36 |
202 ± 34 |
Tch (mg/dL) |
150 ± 51 |
130 ± 39 |
129 ± 42 |
117 ± 22 |
104 ± 19* |
98 ± 17* |
TG (mg/dL) |
175 ± 82 |
162 ± 59 |
198 ± 78 |
154 ± 73 |
209 ± 102* |
226 ± 105* |
Na (mEq/L) |
144 ± 2 |
141 ± 2* |
143 ± 2 |
141 ± 3 |
139 ± 1* |
141 ± 4 |
K (mEq/L) |
5.3 ± 0.7 |
4.6 ± 0.8* |
5.3 ± 1.0 |
5.0 ± 0.9 |
4.4 ± 0.5* |
4.7 ± 0.8 |
Ca (mg/dL) |
11.1 ± 0.9 |
10.3 ± 0.5* |
11.2 ± 1.1 |
11.2 ± 1.4 |
10.6 ± 0.6* |
10.7 ± 1.1 |
Cl (mEq/L) |
99 ± 1.9 |
101 ± 2.3* |
99 ± 3.5 |
99 ± 2.0 |
98 ± 2.3 |
97± 4.3 |
*p<0.05, compared to control
Table 2: Histological findings for the urinary system for rats treated with the test substance
No. of affected rats (%) |
|||||||
|
Males |
Females |
|||||
Test substance concentration (%) |
0 |
2.5 |
5 |
0 |
2.5 |
5 |
|
Effective No. of rats |
40 |
45 |
40 |
41 |
46 |
31 |
|
Urinary system |
|
|
|
|
|
|
|
Kidney
|
renal cell tumor |
0 |
0 |
1(2) |
0 |
0 |
0 |
papillary necrosis |
0 |
2(4) |
3(7) |
0 |
14(30) |
10(32) |
|
calcification |
0 |
0 |
0 |
16(39) |
15(32) |
13(42) |
|
Pelvis
|
transitional hyperplasia |
0 |
0 |
0 |
0 |
2(4) |
0 |
transitional cell tumor |
1(2) |
0 |
0 |
0 |
0 |
0 |
|
papilloma |
0 |
0 |
0 |
0 |
4(8) |
2(6) |
Table 3: Organ distribution and histological diagnosis for tumors in rats treated with the test substance
|
No. of affected rats (%) |
||||||
|
Males |
Females |
|||||
Test substance concentration (%) |
0 |
2.5 |
5 |
0 |
2.5 |
5 |
|
Effective No. of rats |
40 |
45 |
40 |
41 |
46 |
31 |
|
Tumor development |
36(90) |
44(97) |
36(90) |
27(59) |
30(65) |
12(39) |
|
Genital system |
|||||||
Testis |
interstitial cell tumor |
35(87) |
44(97) |
36(90) |
- |
- |
- |
Prostate |
adenoma |
1(2) |
2(4) |
2(4) |
- |
- |
- |
calcification |
- |
- |
- |
- |
- |
- |
|
Uterus |
endometrial polyp |
- |
- |
- |
5(12) |
18(39) |
12(38) |
endometrial sarcoma |
- |
- |
- |
0 |
1(2) |
0 |
|
adenocarcinoma |
- |
- |
- |
1(2) |
0 |
0 |
|
Mammary gland |
firboma |
0 |
0 |
0 |
1(2) |
0 |
0 |
adenoma |
0 |
0 |
0 |
0 |
1(2) |
1(3) |
|
Endocrine system |
|||||||
Pituitary gland |
adenoma |
9(22) |
6(13) |
7(17) |
13(31) |
12(26) |
9(29) |
Thyroid gland |
C-cell adenoma |
4(10) |
1(2) |
3(7) |
4(9) |
3(6) |
2(6) |
C-cell carcinoma |
0 |
2(4) |
1(2) |
1(2) |
1(2) |
0 |
|
papillary adenoma |
1(2) |
0 |
1(2) |
0 |
2(4) |
0 |
|
papillary adenocarcinoma |
0 |
1(2) |
0 |
0 |
0 |
0 |
|
Adrenal gland |
pheochromocytoma |
5(13) |
7(15) |
5(13) |
0 |
1(2) |
0 |
Pancreas |
islet cell tumor |
6(15) |
1(2) |
2(4) |
0 |
1(2) |
0 |
Digestive system |
|||||||
Liver |
neoplastic nodule |
1(2) |
0 |
0 |
0 |
0 |
1(3) |
Respiratory system |
|||||||
Lung |
adenoma |
0 |
2(4) |
0 |
0 |
1(2) |
0 |
Urinary system |
|||||||
Kidney |
renal cell tumor |
0 |
0 |
1(2) |
0 |
0 |
0 |
transitional cell tumor |
1(2) |
0 |
0 |
0 |
0 |
0 |
|
papilloma |
0 |
0 |
0 |
0 |
4(8) |
2(6) |
|
Urinary bladder |
papilloma |
0 |
0 |
0 |
0 |
0 |
0 |
Body cavity |
|||||||
Peritoneum |
mesothelioma |
2(5) |
2(4) |
1(2) |
0 |
0 |
0 |
Hematopoietic system |
|||||||
Leukemia |
|
4(10) |
6(13) |
3(7) |
6(14) |
9(17) |
3(9) |
Integument, musculoskeletal system |
|||||||
Subcutis |
fibroma |
3(8) |
0 |
0 |
4(10) |
2(4) |
0 |
|
lipoma |
0 |
1(2) |
0 |
0 |
0 |
1(2) |
|
preputial/clitoral gland tumor |
3(6) |
2(4) |
2(4) |
0 |
0 |
1(2) |
|
fibrosarcoma |
0 |
0 |
1(2) |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.9.1, of Regulation (EC) No 1907/2006.
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
The available data on carcinogenicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Additional information
Carcinogenicity of glycine after oral administration to male and female Fischer 344/DuCrj rats was investigated by Kitahori et al. (1994). The unchanged test substance was applied continuously via drinking water at 2.5 and 5% for 108 weeks to 50 animals per sex. The concentrations used correspond to 1534 and 3280 mg/kg bw/day for males and to 1587 and 3082 mg/kg bw/d for females, respectively, based on the body weights and water consumption data given in the publication. Control animals received drinking water without the test substance. Dose concentrations were chosen on the basis of a preliminary subacute experiment (unspecified). Observations and examinations comprised body weight development, food and water consumption, haematology, clinical chemistry, urinalysis, gross pathology and histopathology.
Mortality of the high dose group females was slightly increased when compared to controls (31 vs. 41 surviving animals). Mean body weights of both sexes were slightly and dose-dependently inhibited over the whole study period when compared to controls. In the high dose group a slight, but not statistically significant increase in white blood cells was observed in both sexes when compared to controls. In addition, a slight decrease in red blood cells and a statistically significant decrease of the haemoglobin and haematocrit levels was observed in females. In the low dose group females showed a slight, but not statistically significant increase in white blood cells and decrease in red blood cells was observed when compared to controls. In both sexes of both dose groups, the creatine phosphokinase values were significantly lower when compared to controls. Blood urea nitrogen was significantly increased in both sexes of the high dose group. In females of both dose groups, a significant and dose-dependent decrease of total protein and total cholesterol and a significant and dose-dependent increase in triglycerides was observed. Some sporadic effects on isolated parameters were even more observed with regard to clinical chemistry which were considered as not treatement-related.
The incidences of papillary necrosis in male rats fed 2.5 and 5% glycine were 4 and 7%, while the corresponding figures for females were 30 and 32%. Since necrosis of the renal papillae was limited to glycine-treated rats it was very likely linked to the induction of papillomas. Transitional hyperplasia in renal pelvis was observed in 2 female animals of the low dose group. Calcification indices in kidney were 39, 32 and 42% in females of the control, 2.5 and 5% groups, respectively. These effects were considered as non-neoplastic histopathology findings. Overall, tumors in males were found in 90% of the high dose group, 97% of the low dose group and in 90% of the controls, while the corresponding figures for females were 39, 65 and 59%. These tumors were considered to be spontaneous in nature.
With regard to neoplastic histopathology in males, one renal cell tumor was seen in one animal of the high dose group. Renal pelvis papillomas were found in 8% of the low dose group and in 6% of the high dose group females, but not in the controls. Since spontaneous tumors in this tissues are very rare, they were considered as treatment-related. Necrosis of the renal papillae was also limited to glycine-treated rats and were therefore very likely to be linked to the induction of papillomas. Besides necrosis, calcification was observed in female rats. Since untreated and treated animals were affected, calcification in the kidney of females can rather not be linked to the formation of renal pelvis papillomas. Probably, calcification is a common effect in aged female rats. Yasukata et al. (1985) smilarly reported phytic-acid induced calcification in the kidneys. In their study, calcification was also present in the untreated controls. Subchronic intraperitoneal glycine administration was reported by Vasudevan et al. (1987) to result in a 44% incidence of hyperplastic, preneoplastic, and neo-plastic lesions in the urinary bladder (cancer 1/9, papillomas 3/9, and hyperplasia 1/9). The urinary bladder of glycine-treated rats within this study was exposed to high levels of orotic acid as a result of an enhanced urea cycle due to the high glycine levels. High levels of orotic acid were considered to be involved in the tumor formation within this study. The crystalline structure of orotic acid and the subsequent permanent irritating properties to tissues, might be a reason for tumor formation, especially in the renal pelvis, which serves as collecting funnel for the urine where transit time might be high. Oxalic acid is a metabolite after glycine degration. It exists in crystalline shape in aqueous solutions and might therefore be irritating to the renal-bladder-tract, too, leading to the overall formation of renal pelvis papillomas. However, it remains unexplained why the effect is restricted to female animals.
In summary, the hypothesized mechanim is a result of a unrealistic, high glycine uptake. Renal pelvis tumors were observed at administered doses of >1000 mg/kg bw/d, but daily glycine uptake in adult humans is 3 - 5 g, corresponding to 40 - 70 mg/kg bw (body weight of 75 kg). Therefore, renal pelvis papilloma formation is not assumed to be relevant for humans.
References
Yasukata J., Shigihara S., Ichikawa M. and Tomita H. (1985) The influence of food additives on zinc concentration in organs of rats. Biryou Kinziku Taisha 133: 13 -22
Vasudevan S., Laconi E., Abanobi S.E., Rao P.M., Rajalakshmi S. and Sarma D.S. (1987) Effect of glycine on the induction of orotic aciduria and urinary bladder tumorigenesis in the rat. Toxicol Pathol 15: 194 -197
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