Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 repeated dose toxicity of 5-methoxy-2-methylsulphanilic acid based on read-across with similar substances.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data are available for repeated dose toxicity oral exposure of 5-methoxy-2-methylsulphanilic acid. 

We can assume the absence of concern regarding repeated dose toxicity oral exposure of 5-methoxy-2-methylsulphanilic acid based on read-across with two compounds 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.

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" NOAEL for oral repeat dose toxicity to rats is 300 mg/kg/day. The substance was administered to each 6 male and 6 female Sprague-Dawley rats at doses of 0, 100, 300, 1000 mg/kg/day by gavage for 28 days. Toxicological effects were decrease of white blood cell count, total cholesterol and urine pH and enlargement of cecum in males at 1000 mg/kg/day; increase of GPT, decrease of glucose and enlargement of cecum in females at 1000 mg/kg/day.

From information published on ECHA website with reference to an experimental study of 2010 on rats for 28 days regarding sulphanilic acid the NOAEL was determined to be 1000 mg/kg bw for both sexes. The study was conducted according to OECD 407.

 

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 repeated dose toxicity via oral route - systemic effects endpoint:
Read across with similar substances

Justification for classification or non-classification

According to CLP Regulation (EC n. 1272/2008), 5-methoxy-2-methylsulphanilic acid should be not classified for repeated dose 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.