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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No data on the test item is available. With the read-across substances the following results were obtained:


Acute oral, rat (CAS 504-63-2): Discriminating dose > 9450 mg/kg bw


Acute oral, rat (CAS 124-07-2): LD50 > 10000 mg/kg


Acute intraperitoneal, rat (CAS 504-63-2): LD50 > 2000 mg/kg bw

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Please refer to Chapter 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
not specified
Dose descriptor:
discriminating dose
Effect level:
9 450 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source Substance 1 (CAS 504-63-2)
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Please refer to Chapter 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source Substance 2 (CAS 124-07-2)
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to guideline
Guideline:
other: Regulation for the Enforcement of the Federal Hazardous Substances Act
Version / remarks:
Revised, Federal Register, September 17, 1964
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Title 49, Department of Transportation Code of Federal Regulation, Section 173, 240
Version / remarks:
Federal Register, February 12, 1973
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
other: albino
Sex:
male
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality up to 10000 mg/kg bw.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was observed to be > 10000 mg/kg bw.
Executive summary:

In an acute oral toxicity study according to Regulation for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964) and Title 49, Department of Transportation Code of Federal Regulation, Section 173, 240 (Federal Register, February 12, 1973) albino rats were given the test item over a period of 14 days. The animals demonstrated a weight gain of at least 30% over original body weight during the fourteen day test period and were within normal limits for rats of the age, sex and strain used in this study. The LD50 was observed to be > 10000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1941-02-20
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The test item was administered gastrically with the aid of a suitable metal tube to 132 rats, in doses from 1.05 to 19.95 g/kg bw.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1050, 2100, 3150, 4200, 5250, 6300, 7350, 8400, 9450, 10500, 11550, 12600, 13650, 14700, 15750, 16800, 17850, 18900, 19950 mg/kg bw
No. of animals per sex per dose:
At least 5 rats were used for each dose.
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
discriminating dose
Effect level:
9 450 mg/kg bw
Based on:
test mat.
Mortality:
The mortality was found to be 100 % for doses of 18.9 and 19.95 g/kg bw. The mortality varied from 10 to 64 % for doses from 11.55 to 17.85 g/kg bw. No rats died for doses from 1.05 to 9.45 g/kg bw.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral non lethal dose was found to be 9.45 g/kg bw.
Executive summary:

In an acute oral toxicity study the test item was administered gastrically with the aid of a suitable metal tube to 132 rats, in doses from 1050 to 19950 mg/kg bw. The mortality was found to be 100 % for doses of 18900 and 19950 mg/kg bw. The mortality varied from 10 to 64 % for doses from 11550 to 17850 mg/kg bw. No rats died for doses from 1050 to 9450 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
10 000 mg/kg bw
Quality of whole database:
Peer reviewed publications

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on the test item is available. Read-across was done to the two potential degradation products of the registered substance.


In an acute oral toxicity study source substance 1 (CAS 504-63-2) was administered gastrically with the aid of a suitable metal tube to 132 rats, in doses from 1050 to 19950 mg/kg bw. The mortality was found to be 100 % for doses of 18900 and 19950 mg/kg bw. The mortality varied from 10 to 64 % for doses from 11550 to 17850 mg/kg bw. No rats died for doses from 1050 to 9450 mg/kg bw.


In an acute oral toxicity study with source substance 2 (CAS 124-07-2) according to Regulation for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964) and Title 49, Department of Transportation Code of Federal Regulation, Section 173, 240 (Federal Register, February 12, 1973) albino rats were given the source substance (124-07-2) over a period of 14 days. The animals demonstrated a weight gain of at least 30% over original body weight during the fourteen day test period and were within normal limits for rats of the age, sex and strain used in this study. The LD50 was observed to be > 10000 mg/kg bw.


Source substance 1 (CAS 504-63-2) was injected intraperitoneal with increasing dose levels to a group of six mice. The injection volume was 0.01 mL/g bw. The 24 h LD50 was found to be 68.8 mmol/kg bw and the 144 hr LD50 was found to be 62.8 mmol/kg bw. These values coreespond to 5236 mg/kg bw and 4779 mg/kg bw, respectively.


Based on the results both source substances are absolutely non toxic when administrated via the oral routes showing toxicity on in very high doses well above the limit dose of 2000 mg/kg bw. In conclusion this weight of evidence approach shows that also the registered substance is assumed to be absolutely non acute toxic (oral).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is classified and labelled as not acute oral toxic according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.