Reaction mass of calcium sulfate and potassium sulfate and sodium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed to GLP and guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

calcium sulfate, dihydrate

IUPAC Name:

calcium sulfate, dihydrate

Constituent 2

Reference substance name:

10101-41-4

EC Number:

600-148-1

Cas Number:

10101-41-4

IUPAC Name:

10101-41-4

Details on test material:

- Name of test material (as cited in study report): Calcium sulfate dihydrate
- Physical state: Solid (white powder)
- Analytical purity: 99.9%
- Lot/batch No.: Sigma Aldrich Corporation, Lot No. - 109H0166

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9 ~ 11 weeks
- Weight at study initiation: 194.9 ~ 206.6 g (sighting study), 194.9 ~ 203.6 g (main study)
- Fasting period before study: Animals were fasted the night before administration but fodder was offered 3 to 4 hours after the administration

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

DOSAGE PREPARATION: Test substance was dissolved in the distilled water on the day of administration

- Rationale for the selection of the starting dose: In order to determine the appropriate starting dose for the main test, 50, 300 and 2,000 mg/kg of test substance were administered to each animal in a sighting study, but there were no toxic effects at least 2 days after the administration.

Doses:

50, 300 and 2000 mg/kg b.w

No. of animals per sex per dose:

In the screening study one female rat was used in each of the three doses. In the main test a further 4 female rats were administered with 2000 mg/kg of the test material.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality, clinical signs and toxic effects were observed 0.5, 1, 2, 3 and 4 hours after the treatment on the day of administration, after that were observed at least once a day till necropsy. Body weight was measured on day 1, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 581 mg/kg bw

Remarks on result:

other: The LD50 for calcium sulfate dihydrate was > 2000 mg/kg bw. The value has been calculated for calcium sulfate anhydrous

Mortality:

No mortality was observed within every dose level

Clinical signs:

There were no specific clinical signs during test period

Body weight:

Rats showed normal body weight gain during test period

Gross pathology:

No abnormal necropsy opinions in relation to administration of calcium sulfate, dihydrate.

Any other information on results incl. tables

Table 1: Mortality of Females (Group Summary)

 

Dose (mg/kg)	No. Dead/No. Dosed	Number of Deaths
		Days After Dosing
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
50	0/1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
300	0/1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2000	0/5	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Table 2: Incidence of Clinical Signs in Females (Group Summary)

 

Signs observed	Dose level mg/kg	50	300	2000
Appears normals		1/1*	1/1	5/5
*: No. of animals with the sign/No. of animals examined

 

Table 3: Body Weights of Females (group summary)

 

Dose (mg/kg)	Animal Number
		Day 0	Day 1	Day 7	Day 14	Gain
50	1	194.9	214.0	234.2	243.0	48.1
300	2	200.2	225.6	229.6	235.2	35.0
2000	3	206.6	224.6	235.2	247.6	41.0
	4	194.9	214.6	222.4	227.8	32.9
	5	201.8	220.8	232.0	236.2	34.4
	6	203.6	217.6	220.0	224.8	21.2
	7	198.4	217.8	219.4	234.2	35.8
	Mean	201.1	219.1	225.8	234.1	33.1
	SD	4.55	3.79	7.30	8.84	7.30
	N	5	5	5	5	5

 

Table 4: Gross Findings of Females (Group Summary)

 

Dose (mg/kg)	Gross Observation		Frequency
	Location	Observation	Mortalities	Survivors
0	No gross findings		0/0*	1/1
300	No gross findings		0/0	1/1
2000	No gross findings		0/0	5/5
* No. of animals with the sign/No. of animals examined

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information The hydrated form exhibited no signs of toxicity whatsoever at the highest, dose therefore even with a correction to the anhydrous form which is lower that the limit dose, the anhydrous form is also considered not classified. Criteria used for interpretation of results: EU

Conclusions:

The study was performed with calcium sulfate dihydrate which gave an LD 50 >2000 mg/kg. Based on this result the oral LD50 of calcium sulfate anydrous is >1581 mg/kg b.w