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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17/1/1983-23/2/1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-comparable proprietary study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
Pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Sodium chromate: yellow powder
Sodium dichromae: orange/red powder
Potassium dichromate: orange/red powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 7-9 weeks
- Weight at study initiation: Not detailed
- Fasting period before study: 18h
- Housing: Individual
- Diet: ad libitum except pre-dosing period
- Water: ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 24*-74
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5% w/v
- Amount of vehicle (if gavage): variable
- Justification for choice of vehicle: solubility of test material
- Lot/batch no. (if required): -
- Purity: :
Doses:
Sodium chromate: 0.2, 0.5, 1.5, 3.0, 5.0 ml/kg; equivalent to 10, 25, 75, 150 and 250 mg/kg bw
Sodium dichromate: 0.2, 0.5, 1.5, 3.0 and 5.0 ml/kg; equivalent to 10, 25, 75, 150 and 250 mg/kg bw
Potassium dichromate: 0.5, 1.0, 2.0, 4.0 and 6.0 ml/kg; equivalent to 25, 50, 100, 200 and 300 mg/kg bw
No. of animals per sex per dose:
Five/sex
Control animals:
yes
Details on study design:
Animals were administered a single gavage dose and observed for 14 days. Rats were weighed on Days 1, 4, 7, 11 and 14. Gross necropsy was performed on all animals, weights of the brain, lungs, liver, spleen, kidneys and gonads were recorded.
Statistics:
Homogeneity of variance was establised using the F-max test, follwoed by Student;s t-test or Wilcoxon Rank Sum test.

Results and discussion

Preliminary study:
Dose levels of 0.2, 1.0, 2.0, 4.0 and 6.0 ml/kg bw were used for each compound; equivalent to 10, 50, 100, 200 and 300 mg/kg bw. Deaths occurred at >=100 mg/kg bw (sodium chromate), at >=200 mg/kg bw (sodium dichromate) and at >= 200 mg/kg bw (potassium dichromate).
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
129.5 mg/kg bw
95% CL:
118.5 - 142
Remarks on result:
other: Sodium chromate
Sex:
female
Dose descriptor:
LD50
Effect level:
67 mg/kg bw
95% CL:
58.5 - 77
Remarks on result:
other: Sodium chromate
Sex:
male
Dose descriptor:
LD50
Effect level:
123.5 mg/kg bw
95% CL:
107 - 142.5
Remarks on result:
other: Sodium dichromate
Sex:
female
Dose descriptor:
LD50
Effect level:
86.5 mg/kg bw
95% CL:
74 - 101
Remarks on result:
other: Sodium dichromate
Sex:
male
Dose descriptor:
LD50
Effect level:
168 mg/kg bw
95% CL:
154.5 - 182.5
Remarks on result:
other: Potassium dichromate
Sex:
female
Dose descriptor:
LD50
Effect level:
90.5 mg/kg bw
95% CL:
81.5 - 100.5
Remarks on result:
other: Potassium dichromate
Mortality:
Sodium chromate:
In the main study, mortality occurred at dose levels of >=75 mg/kg bw (females) and >=150 mg/kg bw (males) within one day of dosing.
Sodium dichromate:
In the main study, mortality occurred at dose levels of >=75 mg/kg bw (females) and >=150 mg/kg bw (males) within two days of dosing
Potassium dichromate:
In the main study, mortality occurred at dose levels of >=100 mg/kg bw (females) and >=200 mg/kg bw (males) within one day of dosing
Clinical signs:
Sodium chromate: piloerection, tremors, hyperkinesia, sedation, hunched posture, ataxia, diarrhoea, coma (30 minutes - 6 days)
Sodium dichromate: piloerection, hypothermia, hunched posture, hyperkinesia, hypokinesia, prostration, ataxia, diarrhoea, sedation, coma, tremors, epistaxis, soiled coat (30 minutes-6 days)
Potassium dichromate: hunched posture, tremors, hypokinesia, sedation, prostration, coma, piloerection, ataxia, diarrhoea, dacryorrhoea and hyperkinesia (1 minute - 11 days)
Body weight:
Sodium chromate: weight gain was initially reduced in the survivng male rat at 150 mg/kg bw.
Sodium dichromate: weight gain was initially reduced in the survivng male rats at 25, 75 and 150 mg/kg bw.
Potassium dichromate: weight gain by survivng males and females was marginally reduced
Gross pathology:
Sodium chromate: reddened gastric mucosa with abnormal (green) coloring and contents; green areas on lungs
Sodium dichromate: reddened gastric mucosa with abnormal (green) coloring and contents; green areas on lungs
Potassium dichromate: distended and reddened gastric mucosa with abnormal (green) coloring; green areas on lungs
Other findings:
Organ weights were unaffected by treatment with any compound

Any other information on results incl. tables

Dose level

Mortality

Sodium chromate

Sodium dichromate

Potassium dichromate

ml/kg bw

mg/kg bw

M

F

M

F

M

F

6.0

0 (controls)

0

0

0

0

0

0

0.2

10

0

0

0

0

-

-

0.5

25

0

0

0

0

0

0

1.0

50

-

-

-

-

0

0

1.5

75

0

1

0

1

-

-

2.0

100

-

-

-

-

0

4

3.0

150

4

5

5

4

-

-

4.0

200

-

-

-

-

4

5

5.0

250

5

5

4

5

-

-

6.0

300

-

-

-

-

5

5

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of this study indicate that sodium chromate, sodium dichromate and potassium dichromate are classified as (R25) 'Toxic if swallowed' according to EU criteria.
Executive summary:

Groups of rats (5/sex) were gavaged with single doses of sodium chromate, sodium dichromate or potassium dichromate (in water) at dose levels of between 10 and 300 mg/kg bw. Animals were observed for 14 days. Bodyweights were recorded on Days 1, 4, 7, 11 and 14. Gross necropsy was performed on all animals and organ weights recorded.

Deaths occurred at dose levels of >=75 mg/kg bw (sodium chromate, sodium, dichromate) and at >=100 mg/kg bw (potassium dichromate): females were slightly more sensitive than males for all compounds. Signs of toxicity were observed in all groups and included hunched posture, tremors, hypokinesia, sedation, prostration, coma, piloerection, ataxia, diarrhoea, dacryorrhoea and hyperkinesia. Slightly reduced weight gain was seen in some surviving animals. Findings at necropsy were limited to reddening and staining of the stomach, abnormal gastric contents and green staining of the lungs. Organ weights were unaffected by treatment.

LD 50 values were calculated to be:

Sodium chromate: 129.5 (118.5 -142.0) mg/kg bw in males; 67.0 (58.5 -77.0) mg/kg bw in females

Sodium dichromate: 123.5 (107.0 -142.5) mg/kg bw in males; 86.5 (74.0 -101.0) mg/kg bw in females

Potassium dichromate: 168.0 (154.5 -182.5) mg/kg bw in males; 90.5 (81.5 -100.5) mg/kg bw in females