Registration Dossier

Administrative data

Description of key information

Oral acute toxicity was tested according to OECD 401 method in male rats,  leading to a LD50 of 1750 mg act.ingr./kg bw. Dermal acute toxicity was tested according to OECD 402  method in male rabbits, demonstrating a LD50 of 4000 mg act.ingr./kg bw. Acute inhalation toxicity was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 750 mg/kg bw
Quality of whole database:
Reliable (Klimisch 2)

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
Dose descriptor:
LD50
Value:
4 000 mg/kg bw
Quality of whole database:
Reliable (Klimisch 2)

Additional information

Acute oral toxicity

A key acute oral toxicity study (Shaffer, 1957) was conducted with the registered substance containing 78-80% active ingredient, diluted with water to a solution of 5% solids content (act. ingr.), and administered in single doses by gavage to groups of young, male albino rats at dosages of 310, 630, 1250 and 2500 mg act. ingr./kg. All animals died within 24 hours following 2500 mg/kg, but all survived at the lower dosages. The acute oral LD50 was calculated to be 1750 mg/kg with no confidence limits determinable. Following lethal doses the animals exhibited profound depression and severe diarrhea prior to death. Moderate to severe irritation with haemorrhage of the gastrointestinal tract was found at post-mortem examination. At the lower dosages the animals were depressed to greater or lesser degree for 24 to 48 hours, but thereafter regained normal appearance and behaviour. They were observed for a total of seven days following the dose, and then sacrificed. At autopsy there was a greater than usual distension of the intestines in some instances, but otherwise no significant gross findings.

Acute dermal toxicity

A key acute dermal toxicity study (Shaffer, 1957) was conducted with the registered substance containing 78-80% active ingredient. The product as received was supplied to the closely-clipped skin of male albino rabbits in single doses that remained in contact with the skin for a period of 24 hours. Four animals were used at each of three dosage levels, namely 2.5, 5 and 10 mL/kg respectively. The dose was retained by means of a cuff of polyethylene film which encircled the trunk of the animal. At the end of the period of exposure, the cuff and any excess of the dose were removed, and the skin examined for primary irritation. At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose having exhibited extreme depression over this interval. Post-mortem examination gave additional evidence of severe injury to the skin and abdominal wall. At the two lower dosages, there was one death each, and the LD50 was calculated to be 5.0 (2.6-9.6) mL/kg or 4.0 (2.1-7.7) g/kg as contained solids. Erythema and edema were initially quite severe at the lower dosages, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. Survivors were observed for a total of 7 days after application of the dose, and then sacrificed. At autopsy there was no gross pathology that could be related to administration of the product.

Acute inhalation toxicity

Intoxication due to acute inhalation exposure of industrial workers or even the acute inhalation exposure as such is very unlikely for sulfosuccinates due to large particle size, low vapour pressure and high hydrophilic properties of the substance.  Based on these and other physicochemical properties, the inhalation and dermal route are not appropriate, and the default oral route of administration is most appropriate (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity is waived.

 


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
key study

Justification for classification or non-classification

The test substance is classified as HARMFUL and the symbol 'Xn' and risk phrase R 22 'HARMFUL IF SWALLOWED' are required according the EU labelling reulations Commision directive 93/21/EEC. According to CLP regulation (No. 1272/2008 of 16 December 2008), Category 4 classification is warranted for acute oral toxicity. Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the test substance does not need to be classified and has no obligatory labelling requirement for dermal toxicity.