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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 acute toxicity is available with H250 sulphonic acid . Acute toxicity study data from LABS (CAS No: 85536 -14 -7) and LAB (CAS no: 67774-74-7) was used to cover these endpoints. Ten rats per dose (five of each sex) were given oral gavage doses of the test material ranging from 1250 to 1990 mg/kg. The acute oral median lethal dose (LD50) of tested substance in the rat was estimated to be 1470 mg/kg bw (95% CI: >1361-< 1588 mg/kg). The oral LD50 value for H250 sulphonic acid is considered to be 1470 mg/kg bw.  Acute dermal LD50 value for H250 sulphonic acid is also considered as greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

Benzenesulphonic acid, dimethyl-,mono C14-16-alkyl derivative (H250 sulphonic acid) is a UVCB.

Based on structural and functional similarities, data on Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives (LABS; CAS no: 85536-14-7) being registered under REACH, LABS Na (CAS no: 68411-30-3) being registered under REACH and LAB (CAS no: 67774-74-7) being registered under REACH are suitable as supporting study in case where specific data on the substance is lacking.

Acute oral toxicity:

No study on acute toxicity is available with the substance. To cover the acute oral toxicity endpoint of substance, Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives (LABS, CAS No: 85536-14-7) was used from supporting structural analogue substance.

Acute toxicity method was applied to rats with five of each sex per dose level according to OECD Guideline 401. Doses were 1250, 1415, 1580 and 1990 mg/kg. 9 animals in the 1580 and 1990 mg/kg dose died. In the other doses, the number of animals that died were 0 and 3 of 10 for the 1250 and 1415 mg/kg doses, respectively. Post mortem sections showed strong hyperemias and swelling, as well as partial damage to the stomach and intestinal mucosae. Also, effects to the stomach, liver, and peritoneum were seen. The tissue sections showed swelling of the gastric mucosa in 3 animals, as well as the growing together of organs of the abdominal cavity with the diaphragm in 2 animals. The acute oral median lethal dose (LD50) of tested substance in the rat was estimated to be 1470 mg/kg bw (95% CI: >1361 - < 1588 mg/kg). The LD50 value for H250 sulphonic acid is considered to be 1470 mg/kg bw.                     

 

 

Acute inhalation toxicity:

In accordance with column 2 of REACH Annex VIII, in addition to the oral route, for substances other than gases, an acute toxicity study for at least one other route is required. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. As dermal is the most likely route of exposure and acute dermal toxicity data is available, no acute inhalation study is deemed necassary.                                                                                                                                          

 

Acute dermal toxicity:

No study on acute toxicity is available with the substance. To cover the acute dermal toxicity endpoint of substance, Benzene, C10-13-alkyl derivatives (LAB, CAS No: 67774 -74 -7) was used from as supporting structural analogue substance.

The study determined the acute dermal toxicity of the LAB in rats according to OECD 402 guideline. 5 male and 5 female rats were exposed to 2000 mg/kg bw of test substance dermally. Exposure lasted 24 hrs, after which the test substance was removed by washing. The animals were observed for the next 14 days for clinical signs and mortality. All animals were necropsied at the end of the experiment. No animals died during the studies. The dermal LD50 in rats is > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the data from analogue substances, H250 Sulphonic acid should be classified as Acute Oral toxicity Cat 4 and Xn; R22 according to EU CLP regulation and DSD criteria.