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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
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:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
GHS criteria not met
Remarks:
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.
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