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Diss Factsheets

Administrative data

Description of key information

In acute oral toxicity studies, the acute toxic potential of Iotroxic acid was tested orally on male and female mice and rats. The LD50 of the test substance for mice was found to be greater than 9000 mg/kg bw for both male and female mice and rats. In acute dermal toxicity studies, the acute toxic potential of Iotroxic acid was tested dermally on male and female rats and mice. The LD50 of the test substance for rats was found to be 8050 mg/kg bw for males and 7100 mg/kg bw for females. The LD50 of the test substance for mice was found to be 6150 mg/kg bw for males and 6500 mg/kg bw for females.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Collection of data, information on materials and methods are not available.
GLP compliance:
not specified
Limit test:
yes
Specific details on test material used for the study:
no data
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 000 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
In this acute oral toxicity study, the oral LD50 value in rats after treatment with Iotroxic acid is > 9000 mg/kg.
Executive summary:

In an acute toxicity study, the toxic potential of Iotroxic acid was tested orally on male and female rats. The LD50 of the test substance for rats was found to be greater than 9000 mg/kg bw for both males and females.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Collection of data, information on materials and methods are not available.
GLP compliance:
no
Limit test:
yes
Specific details on test material used for the study:
no data
Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 000 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
In this acute oral toxicity study, the oral LD50 value in mice after treatment with Iotroxic acid is > 9000 mg/kg.
Executive summary:

In an acute toxicity study, the toxic potential of Iotroxic acid was tested orally on male and female mice. The LD50 of the test substance for mice was found to be greater than 9000 mg/kg bw for both males and females.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Collection of data, information on materials and methods are not available.
GLP compliance:
not specified
Limit test:
yes
Specific details on test material used for the study:
no data
Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 150 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
6 500 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
In this acute dermal toxicity study, the dermal LD50 value in mice after treatment with Iotroxic acid is 6150 mg/kg bw for males and 6500 mg/kg bw for females.
Executive summary:

In an acute toxicity study, the toxic potential of Iotroxic acid was tested dermally on male and female mice. The LD50 of the test substance for mice was found to be 6150 mg/kg bw for males and 6500 mg/kg bw for females.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Collection of data, information on materials and methods are not available.
GLP compliance:
not specified
Limit test:
yes
Specific details on test material used for the study:
no data
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
8 050 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
7 100 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
In this acute dermal toxicity study, the dermal LD50 value in rats after treatment with Iotroxic acid is 8050 mg/kg for males and 7100 mg/kg bw for females.
Executive summary:

In an acute toxicity study, the toxic potential of Iotroxic acid was tested dermally on male and female rats. The LD50 of the test substance for rats was found to be 8050 mg /kg bw for males and 7100 mg /kg bw for females.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

In acute oral toxicity studies, the acute toxic potential of Iotroxic acid was tested orally on male and female mice and rats. The LD50 of the test substance for mice was found to be greater than 9000 mg/kg bw for both male and female mice and rats.In acute dermal toxicity studies, the acute toxic potential of Iotroxic acid was tested dermally on male and female rats and mice. The LD50 of the test substance for rats was found to be 8050 mg/kg bw for males and 7100 mg/kg bw for females. The LD50 of the test substance for mice was found to be 6150 mg/kg bw for males and 6500 mg/kg bw for females.

Justification for classification or non-classification

Based on the available data, Iotroxic acid does not warrant classification for acute toxicity. The LD50 values for the oral and dermal route were above the limit value for classification (2000 mg/kg bw).