Registration Dossier

Administrative data

Description of key information

The multi-constituent substance 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. is almost non-toxic via oral and dermal routes in test animals. The oral LD50 in rats is >5000 mg/kg bw, the dermal LD50 in rabbits is >2000 mg/kg bw. No test data regarding inhalatory exposure are available. Testing of acute toxicity via inhalation is inappropriate since exposure via this route is not likely due to low vapour pressure and low dustiness of the test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Oral route

The key study for acute oral toxicity in rats was performed with 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. by oral gavage (Mallory, 1994) according to GLP and internationally accepted guidelines. Following a pilot study at 500, 2500 and 5000 mg/kg bw that showed no lethality up to doses of 5000 mg/kg, a limit test was conducted at 5000 mg/kg. Females exhibited no adverse signs, whereas males showed decreased activity and muscular tone and diarrhea.

Therefore, 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. exhibits low toxicity following single dose administration by oral gavage . This results in an LDLo of 5000 mg/kg bw in males and an LD50 >5000 mg/kg in males and females. There was also a support study for acute oral toxicity performed with 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. by oral gavage in rats according to GLP and internationally accepted guidelines (Bomhard & Martins, 1990). In this study, a limit of 2000 mg/kg bw was given. There were no effects observed; the LD50 was above 2000 mg/kg.

Dermal route

The key study for acute dermal toxicity was performed with 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. in rabbits of both sexes in a limit test per according to OECD & GLP guidelines under occlusive dressing for 24h (Merriman, 1995). There were signs of dermal irritation at the application site, including edema and erythema. No chemical-related adverse clinical (behavioral or gross) effects were observed including mortality, body weight changes, or necropsy results. The dermal LD0 = 2000 mg/kg, and LD50 >2000 mg/kg.

Inhalation route

The multi-constituent substance 1,4-benzenediamine, N,N'-mixed Ph and tolyl derivs. has a very low vapour pressure (see vapour pressure section) and virtually no particles of a respirable size are detected upon sieving (see granulometry section). Moreover, the supported uses and exposure scenarios show negligible exposure of humans via the inhalatory route.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC (Dangerous Substances Directive), classification is not necessary for acute toxicity based on the available test data for oral (LD50 > 2000 mg/kg bw) and dermal (LD50 > 2000 mg/kg bw) acute toxicity.

In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for acute toxicity based on the available test data for oral (LD50 > 5000 mg/kg bw) and dermal (LD50 > 2000 mg/kg bw) acute toxicity.

No data regarding inhalation exposure are available. Extrapolation from dermal or oral toxicity can be performed within the scope of classification (C&L Guidance, point 3.1.3.3.4). The dermal and oral LD0 values are 2000 mg/kg bw and 5000 mg/kg bw respectively. Extrapolation to calculate the estimated inhalation dose would result in a value above the classifiable range for inhalation toxicity. So 1,4-benzenediamine, N,N'-mixed Ph and tolyl derivs. should not be classified for acute toxicity by inhalation, based on extrapolation.