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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity :


Based on the data published it was concluded that, the lethal concentration (LD50) value for acute oral toxicity test was considered to be 10000 mg/kg bw.


Acute Inhalation Toxicity :


Waiver


Acute  Dermal Toxicity:


The acute dermal toxicity in rats was noted to be >2000 mg/kg bw, as there were no mortalities observed in any of the animals.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from Authoritative Database
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of test chemical was performed in rats.
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Mortality:
50% mortality was observed at dose 10000 mg/kg bw in treated rats
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: not classified
Conclusions:
Based on the data published it was concluded that, the lethal concentration (LD50) value for acute oral toxicity test was considered to be 10000 mg/kg bw.
Executive summary:

Acute oral toxicity study was performed in fasted rats using test chemical. It was observed that 50% mortality was found at dose of 10000 mg/kg bw. Hence,LD50 value was considered to be 10000 mg/kg bw,when fasted rats were treated with test chemical orally. Thus as per CLP criteria it was concluded that the test chemical does not classified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from authoritative database

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Quality of whole database:
Waiver

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Remarks:
Read across data
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no
Specific details on test material used for the study:
IUPAC name-Theophylline
Molecular formula :C7H8N4O2
Molecular weight :180.166 g/mol
Substance type:organic
Physical state:White solid
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
Not specified
Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
Not specified
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female Wistar rats
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed
Clinical signs:
other: Not specified
Gross pathology:
Not specified
Interpretation of results:
other: Not classified
Conclusions:
The acute dermal toxicity in rats was noted to be >2000 mg/kg bw, as there were no mortalities observed in any of the animals.
Executive summary:

Acute dermal toxicity study was conducted for the read across substance Theophylline (CAS no.: 58 -55 -9, E.C. no. 200 -385 -7) in five male and female Wistar rats. Rats were exposed to the test substance via dermal route. The test substance was exposed to the animals at concentration 2000mg/kg bw in olive oil, for 24 hours. The test site was then covered with semiocclusive patch. The patch was then removed after 24 hours and the application site was washed. The animals were observed for clinical signs of toxicity and mortality for 14 days. No clinical signs of toxicity and no mortalities were observed in any of the animals. Hence, the LD50 concentration was considered to be >2000mg/kg bw, when rats were treated with the given test substance and thus was considered to be "Not classified", as per the CLP criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

Additional information

Acute oral Toxicity :


Study 1 :


Acute oral toxicity study was performed in fasted rats using test chemical. It was observed that 50% mortality was found at dose of 10000 mg/kg bw. Hence,LD50 value was considered to be 10000 mg/kg bw,when fasted rats were treated with test chemical orally. Thus as per CLP criteria it was concluded that the test chemical does not classified for acute oral toxicity.


Study 2 :


Acute oral toxicity study was performed in male Sprague-Dawley rats using test chemical.At dose 5000 mg/kg,no death occured.At dose 10000 mg/kg bw, 4/8 rats died;At dose 125000 mg/kg bw,7/8 rats died,At dose 15000 mg/kg bw,all rats died;At dose 20000 mg/kg bw,7/8 rats died;At dose 30000 mg/kg bw and 40000 mg/kg bw,all the rats died.Hence,LD50 value was considered to be 10000 mg/kg bw,when male Sprague-Dawley rats were treated with test chemical orally via gavage.


Acute Inhalation toxicity :


Waiver


Acute Dermal toxicity :


Study 1:


Acute dermal toxicity study was conducted for the read across substance Theophylline (CAS no.: 58 -55 -9, E.C. no. 200 -385 -7) in five male and female Wistar rats. Rats were exposed to the test substance via dermal route. The test substance was exposed to the animals at concentration 2000mg/kg bw in olive oil, for 24 hours. The test site was then covered with semiocclusive patch. The patch was then removed after 24 hours and the application site was washed. The animals were observed for clinical signs of toxicity and mortality for 14 days. No clinical signs of toxicity and no mortalities were observed in any of the animals. Hence, the LD50 concentration was considered to be >2000mg/kg bw, when rats were treated with the given test substance and thus was considered to be "Not classified", as per the CLP criteria.


Study 2 :


Acute dermal toxicity study was conducted for the read across substance 6 -amino-1,3 -dimethyluracil (CAS no.: 6642 -31 -5, E.C. no.: 229 -662 -0) in five male and female Wistar rats. Rats were exposed to the test substance via dermal route. The test substance was exposed to the animals at concentration 2000mg/kg bw in purified water. The test site was then covered with semiocclusive patch. The animals were observed for clinical signs of toxicity and mortality for 14 days. No clinical signs of toxicity and no mortalities were observed in any of the animals. Hence, the LD50 concentration was considered to be >2000mg/kg bw, when rats were treated with the given test substance and thus was considered to be "Not classified", as per the CLP criteria.

Justification for classification or non-classification

Based on the above experimental studies on Nickel(II) EDTA complex (25481-21-4) and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Nickel(II) EDTA complex (25481-21-4)cannot be classified for acute oral toxicity.