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Diss Factsheets

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
Study period:
1967
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
other: Acute Oral Toxicity
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
other: distilled water
Details on oral exposure:
no data
Doses:
500, 625, 750 or 1000 mg/kg bw (as base) in a dose volume of 20 mL/kg bw distilled water.
No. of animals per sex per dose:
Ten animals per dose were tested.
Control animals:
yes
Details on study design:
The animals were dosed orally at 500, 625, 750 or 1000 mg/kg bw (as base) in a dose volume of 10 mL/kg bw distilled water. Controls received distilled water at 20 mL/kg bw.
In general, the rats were observed for seven consecutive days for death and the LD50 with 95% Fieller Confidence Limits was calculated. Due to the death of 750 mg/kg bw dose the study was continued two additional days. No additional animals died during that period.
Statistics:
no data
Preliminary study:
not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
608 mg/kg bw
95% CL:
>= 337 - <= 777
Mortality:
Dose (mg/kg bw) Dead/Tested
500 4/10
625 4/10
750 7/10
1000 9/10
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no data

Mortality

Dose Dead/Tested

500 mg/kg bw, 4/10

625 mg/kg bw, 4/10

750 mg/kg bw, 7/10

1000 mg/kg bw, 9/10

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 with 95% Fieller Confidence Limits was determined to be 608 (337 – 777) mg/kg bw.
Executive summary:

Female Charles River rats, weighing between 100 and 155 g, were used in this study.

The animals were dosed orally at 500, 625, 750 or 1000 mg/kg bw (as base) in a dose volume of 10 mL/kg bw distilled water. Controls received distilled water at 20 mL/kg bw.

Ten animals per dose were tested. In general, the rats were observed for seven consecutive days for death and the LD50 with 95% Fieller Confidence Limits was calculated. Due to the death of 750 mg/kg bw dose the study was continued two additional days. No additional animals died during that period.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
other: Acute Oral Toxicity
Limit test:
no

Test material

Test animals

Species:
mouse
Strain:
CF-1
Sex:
male
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: distilled water
Details on oral exposure:
not applicable
Doses:
500, 625, 750, 1000, 1250, 1750 mg/kg bw (as base) in a dose volume of 10 or 30 mL/kg bw distilled water.
The 500 - 1000 mg/kg bw doses were given at 10 mL/kg bw. As the data was insufficient to calculate an LD50, additional higher doses were tested. A 30 mL/kg bw was used for these higher doses. Controls received distilled water at 20 and 30 mL/kg bw.
No. of animals per sex per dose:
Ten animals per dose
Control animals:
yes
Details on study design:
500, 625, 750, 1000, 1250, 1750 mg/kg bw (as base) in a dose volume of 10 or or 30 mL/kg bw distilled water. The 500 - 1000 mg/kg bw doses were given at 10 mL/kg bw. As the data was insufficient to calculate an LD50, additional higher doses were tested. A 30 mL/kg bw was used for these higher doses. Controls received distilled water at 20 and 30 mL/kg bw.
The mice were observed for seven consecutive days for death and the LD50 with 95% Fieller Confidence Limits was calculated.
Statistics:
NA

Results and discussion

Preliminary study:
not applicable
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
929 mg/kg bw
95% CL:
>= 760 - <= 1 141
Mortality:
Dose (mg/kg bw)  Dead/Tested
500             2/10
625            0/10
750             2/10
1000          5/10
1250            8/10
1500           10/10
1750            9/10
Resulting LD50 with 95% Fieller Confidence Limits (CL): 929 (760 - 1141) mg/kg
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
not applicable

Any other information on results incl. tables

Mortality

Dose               Dead/Tested

500 mg/kg bw, 2/10

625 mg/kg bw, 0/10

750 mg/kg bw, 2/10

1000 mg/kg bw, 5/10

1250 mg/kg bw, 8/10

1500 mg/kg bw, 10/10

1750 mg/kg bw, 9/10

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 with 95% Fieller Confidence Limits was determined to be 929 (760 – 1141) mg/kg bw.
Executive summary:

Male Carworth Farms CF-1S mice, weighing between 18 and 26 g were dosed orally at 500, 625, 750, 1000, 1250, 1500 or 1750 mg/kg bw (as base) in a dose volume of 10 or 30 mL/kg bw distilled water. The 500 - 1000 mg/kg bw doses were given at 10 mL/kg bw. As the data was insufficient to calculate an LD50, additional higher doses were tested. A 30 mL/kg bw was used for these higher doses. Controls received distilled water at 10 and 30 mL/kg bw.

Ten animals per dose were tested. The mice were observed for seven consecutive days and the LD50 with 95% Fieller Confidence Limits were calculated. The LD50 with 95% Fieller Confidence Limits in CF-1S mice was determined to be 929 (760 – 1141) mg/kg bw.