Calcium sulfide (Ca(Sx))

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Remarks:

Tessenderlo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

See it in the attachement on page 7 in the procedure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

100-5000 mg/kg of body weight

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

See it in the attachement.

Statistics:

Lithcfield, J. Jr., and Wilcoxon, F.J. Pharm. Exp. Therap. 96: 99-115 (1949)

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 920 mg/kg bw

Based on:

test mat.

95% CL:

> 773 - < 1 095

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 820 mg/kg bw

Based on:

test mat.

95% CL:

> 773 - < 1 095

Mortality:

See it in the attachement on page 8 in the mortality summary table

Clinical signs:

other: See it in the attachement on page 7 in the results

Gross pathology:

See it in the attachement on page 7 in the results

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

It is classified as H302 ( acuter oral toxicity category 4)

Executive summary:

LD 50 is 820 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

820 mg/kg bw

Quality of whole database:

Klimisch 1.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Remarks:

Tessenderlo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation, Human and Domestic Animals, November 1984

GLP compliance:

yes (incl. QA statement)

Test type:

traditional method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Hilltop Lab Animals, Scottdale, PA (15 males and 15 females)

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

>= 1.8 - <= 2.35 µm

Details on inhalation exposure:

See it in the attachement page 17-18

Duration of exposure:

ca. 4.5 h

Concentrations:

2.41 mg/l , 3.78 mg/l and 5.08 mg/l

No. of animals per sex per dose:

5 female and 5 male rats

Control animals:

no

Statistics:

Probit Analysis

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 3.6 mg/L air (nominal)

Based on:

test mat.

95% CL:

>= 2.93 - <= 4.42

Exp. duration:

4.5 h

Mortality:

At 2.41 mg/l the mortality is 30%
At 3.78 mg/l the mortality is 40%
At 5.08 mg/l the mortality is 80%
See it in the attachement on Page 30 Table 11

Clinical signs:

other: At 2.41 mg/l at 12 page Exposure level 2nd paragraph At 3.78 mg/l at 13. page Exposure level 2nd paragraph At 5.08 mg/l at 13. page Exposure level 2nd paragraph

Body weight:

Measured but not evaluated.

Gross pathology:

At 2.41 mg/l the 12 page Exposure level 3rd paragraph
At 3.78 mg/l the 13 page Exposure level 3rd paragraph
At 5.08 mg/l the 14 page Exposure level 3rd paragraph

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

H332

Conclusions:

LC50: 3.6 mg/l See it in the attachement on page 14 in the conclusion.

Executive summary:

It is classified as acute tox inhalation category 4 (H332).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

3 600 mg/m³ air

Quality of whole database:

Klimisch 1

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA FIFRA guidelines Pesticide Assessment Guidelines Subsection F

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Elkhorn Rabbitry, Watsonville, CA
5 males and 5 females weighting at least 2 kg each

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

See it in the attachement page 5. procedure 3.4.5. paragraph.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 female and 5 male rabbits

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the test period.

Clinical signs:

other: Several local irritation including necrosis was observed on all of the animals on the skin of the test sites. Wounds were beaginnig to heal by day 10. No systemic toxic signs were observed during the test.

Gross pathology:

No test compound related abnormalities were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

At a dermal dose of 2000 mg/kg bw, this test compund produces no mortalities among male and female NZW rabbits.

Executive summary:

At a dermal dose of 2000 mg/kg bw, this test compund produces no mortalities among male and female NZW rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 001 mg/kg bw

Quality of whole database:

At a dermal dose of 2000 mg/kg bw, this test compund produces no mortalities among male and female NZW rabbits.

Justification for classification or non-classification

It is classified as H302 and H332 ( acute tox category 4)