Registration Dossier

Administrative data

Description of key information

There are 6 acute oral, 4 acute dermal and one acute inhalation studies, a number of which are guideline GLP studies, for different hydrotrope substances.

By EU criteria these hydrotrope substance are deemed "practically non-toxic" for oral, dermal and inhalation exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
7 000 mg/kg bw
Quality of whole database:
Sufficient to meet requirements

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
6 410 mg/m³
Quality of whole database:
Sufficient to meet requirements

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Sufficient to meet requirements

Additional information

There are a total of 11 acute toxicity studies on the hydrotrope category substances, six by the oral route, four by the dermal route and one by inhalation.

 

The key acute oral study is a 1982 study with sodium cumene sulphonate which follows OECD 401 guideline but not GLP. It is a limit test of 5 males and 5 females exposed at 7000 mg/kg bw . Two female rats died. There were some clinical signs of stress following dosing but all animals were free of clinical symptoms at 24 hours. There were no effects on body weights and no pathological changes at the 14 day necropsy. The LD50 was recorded as greater than 7000 mg/kg bw and per EU criteria the test substance was deemed "practically non-toxic". The other 5 oral studies show comparable results.

 

The key acute dermal toxicity is a 1968 study with sodium cumene sulphonate which is generally equivalent to OECD 402. It was a limit test. Six rabbits (3 with shaved and abraded skin and 3 with intact shaved skin) were exposed to 2000 mg/kg bw. There were no deaths but primary irritation was reported at the site of exposure. Body weights were normal at 14 days and there were no gross pathology or histopathology noted at sacrifice. The dermal LD50 is reported as >2000 mg/kg bw. The other three acute dermal studies reported comparable results.

 

The key acute inhalation study is a 1980 (non-GLP) study with ammonium xylene sulphonate. This is a 232-minute, limit test, involving exposure of male and female rats with no vehicle and a 14-day post exposure observation period. There were no deaths at the 6.41 mg/L dose. Aerosolization was done by a DeVilbiss Nebulizer and exposures were in glass chambers. One of the 10 animals demonstrated clinical signs (soft stool), 2 of the 10 had slight weight gains at days 7 and 14, and 5 of the 10 showed slight mottling or a moderate congestion of lungs at necropsy. The conclusion was reported as "practically nontoxic".

Justification for classification or non-classification

The available studies with oral, dermal and inhalation exposure demonstrate that the members of the hydrotrope category are of low acute toxicity. No classification is warranted.