Reaction mass of chromium (+ 3) hydroxide sulfate and sodium sulfate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Proprietary study, reported in summary form only but in sufficent detail to allow reliable interpretation of the adequacy of the method and results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The study is not reported in great detail but appears to be broadly comparable to OECD 401; bodyweights were not measured and gross necropsy not performed.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chromium hydroxide sulphate

EC Number:

235-595-8

EC Name:

Chromium hydroxide sulphate

Cas Number:

12336-95-7

Molecular formula:

CrHO5S

IUPAC Name:

chromium hydroxide sulphate

Details on test material:

The test material is referred to as 'Chromosal B'

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Male Wistar rats (160-180 g) were obtained from Winkelmann (Germany) and were group housed (5 animals/cage)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

No further details

Doses:

1000, 3100, 3500, 4000, 4500 and 5000 mg/kg bw

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

No further details

Statistics:

LD50 calculation according to the method of Fink & Hund (Arzneimittel-Forschung 15, 624; 1965)

Results and discussion

Preliminary study:

Not reported

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LDLo

Effect level:

3 100 mg/kg bw

Remarks on result:

other: 1/10 rats

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 530 mg/kg bw

95% CL:

3 190 - 3 790

Effect levels 3

Sex:

male

Dose descriptor:

LD100

Effect level:

5 000 mg/kg bw

Mortality:

Deaths occured at 3100 mg/kg bw (1), 3500 mg/kg bw (7), 4000 mg/kg bw (7), 4500 mg/kg bw (9) and 5000 mg/kg bw (10).

Clinical signs:

other: Signs of toxicity (emaciation, red staining of the eyes and nose, reduction in common parameters) were seen in all animals at dose levels of 3100 mg/kg bw and greater

Gross pathology:

Not reported

Other findings:

No other findings are detailed

Any other information on results incl. tables

The results of the study are tabulated below. The LD50 in male rats was found to be >3100 mg/kg bw and was calculated to be 3530 (3190 -3790) mg/kg bw.

Dose level (mg/kg bw)	No. animals	Signs of toxicity	Deaths	Time of death
1000	10	-	-	-
3100	10	10	1	3h
3500	10	10	7	2-9d
4000	10	10	7	2-5d
4500	10	10	9	2-7d
5000	10	10	10	2-4d

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test material was calculated to be 3530 mg/kg bw. Classification for acute oral toxicity according to current EU criteria is not required.

Executive summary:

In a study comparable to OECD Test Guideline 401 Wistar rats (10 males/group) were gavaged with a single dose of the test material (in water) at dose levels of 1000, 3100, 3500, 4000, 4500 or 5000 mg/kg bw and observed for 14 days. Deaths occurred at 3100 mg/kg bw (1), 3500 mg/kg bw (7), 4000 mg/kg bw (7), 4500 mg/kg bw (9) and 5000 mg/kg bw (10) within 9 days of exposure. Signs of toxicity (emaciation, red staining of the eyes and nose, reduction in common parameters) were observed at dose levels of 3100 mg/kg bw and above. The LD50 was calculated to be 3530 (3190 -3790) mg/kg bw.