Sodium dichromate

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

Sodium dichromate

EC Number:

234-190-3

EC Name:

Sodium dichromate

Cas Number:

10588-01-9

Molecular formula:

Cr2Na2O7

IUPAC Name:

sodium dichromate

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

123.5 mg/kg bw

95% CL:

> 107 - < 142.5

Remarks on result:

other: Sodium dichromate

Effect levels 2

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".