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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Principles of method if other than guideline:
The test material was orally administered to Wistar rats daily for a period of 28 d. Animals were sacrificed after test material treatment to determine hematological indices.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Zinc chloride
EC Number:
231-592-0
EC Name:
Zinc chloride
Cas Number:
7646-85-7
IUPAC Name:
zinc dichloride
Details on test material:
- Name of test material (as cited in study report): Zinc chloride

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 2 months
- Weight at study initiation: 150-180 g
- Housing: Housed singly in cages
- Diet (e.g. ad libitum): Standard granulated rodent laboratory chow-LSM (CLPP, Motycz near Lublin)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 60±10
- Photoperiod (hrs dark / hrs light): Natural day-night light cycles


Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on oral exposure:
Not reported
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
Not applicable
Duration of treatment / exposure:
28 d
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0 and 0.12 mg Zn/cm3
Basis:
nominal in water
No. of animals per sex per dose:
Control group: 12 males and 12 females
Treatment group: 13 males and 17 females
Control animals:
yes, concurrent vehicle
Details on study design:
Not reported
Positive control:
Not reported

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: Yes


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes


HAEMATOLOGY: Yes
- Anaesthetic used for blood collection: Yes (ether)
- How many animals: 13 males and 17 females in treatment group and 12 males and 12 females in control group
- Parameters checked in table [No. 3, 4, 5 and fig. 2] were examined.







Sacrifice and pathology:
Not reported
Other examinations:
None
Statistics:
Students t-test at the significance level P < 0.05

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not examined
Details on results:
CLINICAL SIGNS AND MORTALITY: No mortality observed (For details see table 1)


BODY WEIGHT AND WEIGHT GAIN: Body weight increment of treated animals was similar to that of the controls. (For details see table 1 and fig. 1)


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Statistically significant decrease in food consumption was noted in treated animals as compared to that of the control group. (For detials see table 2)


HAEMATOLOGY: Statistically significant decrease in the erythrocyte count and haemoglobin level was found in the peripheral blood of treated animals. The haematocrit index decreased only slightly. (For details see table 3). Statistically significant increase in leukocyte count was noted in the treated males (For details see table 3). Percentage of reticulocytes and polychromatophilic erythrocytes in the peripheral blood of treated animals increased significantly as compared with that in the controls (For details see fig. 2). No major changes in the percentage composition of bone marrow cells between the control and treated animals observed. (For details see table 5)

Effect levels

Dose descriptor:
other: Significant increase in percentage of reticulocytes and polychromatophilic erythrocytes and statistically significant decrease in the erythrocyte count and haemoglobin level in the peripheral blood observed.
Effect level:
0.12 other: mg Zn/cm3
Sex:
male/female
Basis for effect level:
other: Haematology

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Table1: The effect of zinc chloride (ZC) on body weight gain in rats

Group of animals Initial number of animals Mortality Number of animals examined Body weight gain 
Males     g g/24 h
Control 12 0 12 84.83 ± 6.42  3.03 ± 0.23
ZC 13 0 13 78.81 ± 4.07  2.82 ± 0.14
Females
Control 12 0 12 36.70 ± 2.41  1.32 ± 0.09
ZC 17 0 17 40.53 ± 2.49  1.45 ± 0.09

Table 2: Food, fluid and zinc intake in the studied animal groups

Group of animals Food intake (g/rat/24 h) Fluid intake (cm3/rat/24h) Zinc (mg/kg body wt/24 h)
Males   
Control 27.02 ± 0.64 26.40 ± 0.70 -
ZC 22.97 ± 0.40 19.85 ± 0.46*** 11.66 ± 0.61
Females   
Control 20.83 ± 0.34 25.20 ± 1.35 -
ZC 19.79 ± 0.27* 18.36 ± 0.85*** 12.75 ± 1.09

Table 3: Haematological indices of peripheral blood in the studied animal groups

Group of animals Erythrocytes x1012/dm3 Haemoglobin nmol/L Haematocrit (I)a Leukocytes x 109/dm3
Males    
Control 8.25 ± 0.10 9.96 ± 0.22 0.48 ± 0.003 8.73 ± 0.72
ZC 7.67 ± 0.15** 8.79 ± 0.23** 0.46 ± 0.004 12.60 ± 1.09*
Females
Control 8.31 ± 0.09 10.27 ± 0.34 0.48 ± 0.003 8.86 ± 0.65
ZC 7.46 ± 0.15*** 8.56 ± 0.24** 0.46 ± 0.005 10.72 ± 0.94

a unit "one"

Table 4: Leukocyte picture of peripheral blood in rats

Group of animals Several forms of leukocytes (109/dm3
Neutrophils Eosinophils Monocytes Lymphocytes
Males    
Control 1.23 ± 0.20 0.13 ± 0.03 0.35 ± 0.06 7.02 ± 049
ZC 2.40 ± 0.45* 0.12 ± 0.02 0.35 ± 0.05 9.73 ± 0.73**
Females    
Control 1.44 ± 0.21 0.17 ± 0.03 0.41 ± 0.06 6.85 ± 0.46
ZC 1.59 ± 0.19 0.21 ± 0.05 0.36 ± 0.04 8.56 ± 0.72

Table 5: % composition of bone marrow cells in the studied animal groups

Males Females
Number of animals Control ZC Control ZC
Proerythroblasts 0.40±0.08 0.35 ± 0.06 0.44 ± 0.07 0.52±0.09
Basophilic erythroblasts 2.98 ± 0.20 2.80 ± 0.02 3.46 ± 0.23 3.25 ± 0.24
Polychroamtophilic eryhtoroblasts 9.81 ± 0.41 9.46 ± 0.35 10.36 ± 0.48 9.97 ± 0.41
Orthochromatic eryhtoroblasts 23.08 ± 0.93 24.51 ± 1.13 24.21 ± 1.08 22.61 ± 0.71
Myeloblasts 2.39 ± 0.19 1.76 ± 0.10* 2.75 ± 0.30 2.30 ± 0.14
Neutrophil granulocytes 29.89 ± 1.01 27.78 ± 1.43 25.78 ± 1.57 28.32 ± 0.84
Eosinophil granulocytes 3.55 ± 0.32 2.95 ± 0.25 5.36 ± 0.75 4.09 ± 0.33
Basophil granulocytes 0.79 ± 0.08 1.08 ± 0.14 0.92 ± 0.12 1.22 ± 0.18
Lymphocytes 18.26 ± 1.06 20.37 ± 2.19 18.33 ±0.90 19.26 ± 0.88
Monocytes 2.12 ± 0.13 2.34 ± 0.17 1.94 ± 0.12 2.09 ± 0.12
Plasma cells  0.40 ± 0.09 0.41± 0.07 0.52 ± 0.09 0.36 ± 0.06
Reticulum cells 5.72 ± 0.24 5.59 ± 0.23 5.26 ± 0.45 5.44 ± 0.31
Macrophagic reticulum cells 0.53 ± 0.08 0.60 ± 0.08 0.68 ± 0.09 0.56 ± 0.06

Significantly different from control group: *P < 0.05, **P < 0.01, ***P < 0.001

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test, the test material was observed to alter haematological parameters in Wistar rats.
Executive summary:

A study was conducted in Wistar rats to assess the effect of test material on certain haematological parameters.

 

Animals were treated orally at a concentration of 0.12 mg Zn/cm3 daily for 28 d. Significant increase in percentage of recticulocytes and polychromatophilic erythrocytes and statistically significant decrease in the erythrocyte count and haemoglobin level in the peripheral blood was observed. No major changes in the percentage composition of bone marrow cells between the control and treated animals were observed.

 

Under the conditions of this test, the test material was observed to alter haematological parameters in Wistar rats.