Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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

Constituent 1
Chemical structure
Reference substance name:
Sodium dichromate
EC Number:
234-190-3
EC Name:
Sodium dichromate
Cas Number:
10588-01-9
Molecular formula:
Cr2Na2O7
IUPAC Name:
disodium [(oxidodioxochromio)oxy]chromiumoylolate dihydrate
Details on test material:
No further details

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 7-9 weeks
- 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
- 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
Doses:
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
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. Tissue samples were taken at necropsy, however no histopathology was performed.
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; equivalent to 10, 50, 100, 200 and 300 mg/kg bw. Deaths occurred at >=200 mg/kg bw
Effect levelsopen allclose all
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
Mortality:
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
Clinical signs:
other: Piloerection, hypothermia, hunched posture, hyperkinesia, hypokinesia, prostration, ataxia, diarrhoea, sedation, coma, tremors, epistaxis, soiled coat (30 minutes-6 days)
Gross pathology:
Reddened gastric mucosa with abnormal (green) coloring and contents; 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

ml/kg bw

mg/kg bw

males

females

6.0

0

0

0

0.2

10

0

0

0.5

25

0

0

1.5

75

0

1

3.0

150

5

4

5.0

300

4

5

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
According to the classification criteria of CLP regulation (EC) 1272/2008 and subsequent regulations sodium dichromate is classified as acute oral toxic Category 3 with the signal word "Danger" and the hazard statement "H301-Toxic if swallowed".
Executive summary:

Groups of rats (5/sex) were gavaged with single doses of sodium dichromate (in water) at dose levels of between 10 and 300 mg/kg bw. Animals were observed for 14 days. Body weights 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: females were slightly more sensitive than males. 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 123.5 (107.0 -142.5) mg/kg bw in males; 86.5 (74.0 -101.0) mg/kg bw in females.

According to the classification criteria of CLP regulation (EC) 1272/2008 and subsequent regulations sodium dichromate is classified as acute oral toxic Category 3 with the signal word "Danger" and the hazard statement "H301-Toxic if swallowed".