Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Low concern for acute toxicity of 5-methoxy-2-methylsulphanilic acid based on read-across with similar substances.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Data from reliable sources (SIDS dossier of 4-aminotoluene-3-sulfonic acid and ECHA website for sulphanilic acid)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Data from reliable sources (ECHA website)

Additional information

No data are available for acute toxicity of 5-methoxy-2-methylsulphanilic acid.

A low acute toxicity for 5-methoxy-2-methylsulphanilic acid was expected based on read-across data with 2 substances of similar structure (more similar substance: 4-aminotoluene-3-sulfonic acid; less similar substance: sulphanilic acid).

For justification of read-across see attachment document in section 13.

 

Oral exposure:

No data are available for acute oral toxicity of 5-methoxy-2-methylsulphanilic acid. The presumable absence of classification for oral acute toxicity regarding 5-methoxy-2-methylsulphanilic acid is supported by read-across with two compounds of similar structure.

As reported in SIDS Dossier of 4-aminotoluene-3-sulfonic acid approved at SIAM 16 (27 -30 May 2003) with reference to Ministry of Health & Welfare, Japan (1996): Toxicity Testing Reports of Environmental Chemicals, vol.4 p.99-106, "Twenty-eight-day Repeat Dose Oral Toxicity Test of 2-Amino-5-methylbenzenesulfonic acid in Rats" from the outcome of a single dose administration reported in a preliminary examination of a 28-Day Repeat Dose Toxicity study (OECD TG407), the oral LD50 in rats is considered to be greater than 2000 mg/kg in both sexes. Also from information from ECHA website with reference to an experimental study of 2010 regarding sulphanilic acid LD50 rat greater than 2000 mg/kg is reported.

 

Inhalation exposure:

No data are available for inhalation toxicity of 5-methoxy-2-methylsulphanilic acid. No read-across is possible with substances with similar structure due to lack of data.

Dermal exposure:

No data are available for dermal toxicity of 5-methoxy-2-methylsulphanilic acid. For a similar compound (sulphanilic acid) on ECHA website with reference to experimental study of 2010 LD50 dermal rat greater than 2000 mg/kg is reported.

The public ECHA database contains data that are proprietary and cannot be used without the formal consent of the owner. In this summary, some of them have been used for precautionary purposes and for the benefit of the human health and the environment. Those data are not necessary for the registration of the target substance which is used exclusively as isolated and transported intermediate, but they can be very helpful for a better definition of the (eco) toxicological property of the substance. No other use and no commercial advantage will derive from the use of those data.


Justification for selection of acute toxicity – oral endpoint
Read across with substances with similar structures.

Justification for selection of acute toxicity – dermal endpoint
Read across with substances with similar structures.

Justification for classification or non-classification

According to CLP Regulation (EC n. 1272/2008), 5-methoxy-2-methylsulphanilic acid should be not classified for acute toxicity : no data are available for the substance but from read-across with 4-aminotoluene-3-sulfonic acid and sulphanilic acid there is no reason of concern.