Registration Dossier

Administrative data

Description of key information

An oral LD50 of 1410 mg/kg bw for p-toluenesulhonate and an oral LD50 of 841 mg/kg bw for ethylenediamine (both constituents of ethylenediamine p-toluenesulphonate) were determined in two acute oral toxicity studies.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
841 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies on acute oral toxicity of ethylenediamine p-toluenesulphonate were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. Two acute oral toxicity studies of the two constituents p-toluenesulphonate and ethylenediamine are available.

Five Sprague-Dawley rats per sex per dose were exposed to 316, 464 or 681 mg/kg bw ethylenediamine dissolved in water via oral gavage (BASF 1979). Ten Sprague-Dawley rats per sex per dose were exposed to 825, 1000, 1250 or 1470 mg/kg. After an observation period of 14 days the surviving animals were necropsied. Dyspnea, spasmodic respiration, apathy, abnormal position, staggering, spastic gait, orange-yellow urine, piloerection, diarrhea, cyanosis, exsiccosis, salivation, blood in the feces and a poor general condition were observed amongst exposed animals. Acute dilation on the right side and acute congestion of the heart, diffuse reddening of the glandular stomach, diarrheal content, atonic and reddened intestine in several cases, and extensive hemorrhages of the thymus were observed amongst animals that died upon necropsy. In several sacrificed animals a slightly indurated forestomach and adhesion of the forestomach to the liver were observed upon necropsy. The LD50 was determined to be 841 and 893 mg/kg bw for male and female rats, respectively. The LD50 was determined to be 866 mg/kg bw for male and female animals combined.

In an OECD 401 guideline study, performed according to GLP, five female Wistar rats per dose were exposed to 1250, 1600 and 2000 mg/kg bw p-toluenesulphonate dissolved in water via oral gavage (Hoechst 1988). An additional five male Wister rats were exposed to 2000 mg/kg bw. After an observation period of 28 days the surviving animals were necropsied. Decreased spontaneous activity, crouching, reduced size flanks, irregular breathing, uncoordinated gait, long legged gait, staggering gait, blepharophimosis, ruffled fur, lacrimation, lying in the prone or lateral position, crawling-like movement forward, decreased proprioceptive reflex, miosis, diarrhea, hypersensitive to touch and a swollen abdomen were observed among the exposed animals. During gross pathology abnormalities were detected in the liver, lung, gastrointestinal tract, spleen and adrenal glands. Two out of five male animals exposed to 2000 mg/kg bw died. For the female animals the LD50 was determined to be 1410 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Two acute oral toxicity studies are available. Each study is performed with one of the two components of ethylenediamine p-toluenesulphonate. The lowest LD50 is used for classification and labeling

Justification for classification or non-classification

Based on an oral LD50 of 1410 mg/kg bw for p-toluenesulphonate and an oral LD50 of 841 mg/kg bw for ethylenediamine, which are both constituents of ethylenediamine p-toluenesulphonate, ethylenediamine p-toluenesulphonate has to be classified for Acute toxicity Cat 4: H302: Harmful if swallowed in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and Xn R22: Harmful is swallowed in accordance with EU Directive 67/548 (DSD).