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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Not acutely toxic

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 total
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One animal died receiving this dose
Clinical signs:
isolated instances of diarrhea, chromorhinorrhea, ptosis, and chromodacryorrhea
Body weight:
Not specified
Gross pathology:
At necropsy, gross observations were normal for eight animals. Necropsy of the remaining two animals revealed the following changes in either one or both animals: red and/or yellow areas in the intestines, red areas in the stomach, mottled liver, mottled spleen, mottled kidneys, dark lungs, red exudate in the anogenital area, and a large amount of blood in the bladder.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated for acute oral toxicity in rats using a limit test dose of 5000 mg/kg bw. The LD50 of the test substance was greater than this dose. According to GHS criteria for acute oral toxicity, criteria for classification for acute oral toxicity are not met.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
adequate

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Reason / purpose for cross-reference:
read-across 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:
yes
Specific details on test material used for the study:
Not specified
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Not specified
Duration of exposure:
Not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6 total
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
one animal receiving this dose died
Clinical signs:
Isolated instances of lethargy, diarrhea, ptosis, and yellow nasal discharge, and moderate erythema (six rabbits), slight edema (one rabbit), and moderate edema (five rabbits).
Body weight:
Not specified
Gross pathology:
At necropsy, gross observations were normal for three animals. Necropsy of the remaining animals revealed the following changes: red areas in the intestines, mottled liver, white nodules in the liver, dark areas in the lungs, mottled kidneys, pale kidneys, dark spleen, and dark areas in the stomach.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated for acute dermal toxicity in rabbits using a limit test dose of 5000 mg/kg bw. The LD50 of the test substance was greater than this dose. According to GHS criteria for acute dermal toxicity, criteria for classification for acute dermal toxicity are not met.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
adequate

Additional information

Justification for classification or non-classification

The LD50 values for acute lethality for analogue substances do not meet the criteria for classifcation according to Regulation EC No. 1272/2007.