Registration Dossier

Administrative data

Description of key information

Valid studies for acute oral, dermal and inhalation toxicity are available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
591 mg/kg bw
Quality of whole database:
The materials/methods and results are described in detail and are sufficient for evaluation.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
877 mg/m³
Quality of whole database:
The materials/methods and results are described in detail and are sufficient for evaluation.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The materials/methods and results are described in detail and are sufficient for evaluation.

Additional information

Five male and five female Wistar rats received a single dose of 200, 356, 632, 1124, or 2000 mg/kg bw (male rats) and 200, 356, 474, 632, or 2000 mg/kg bw (female rats) of 1,8-naphtylendiamine per gavage. For male rats a LD50 in the range between 1124 and 2000 mg/kg bw was found, and for female rats a LD50 of 591 mg/kg bw was determined.

Four groups of 5 male and 5 female Wistar rats were nose/head-only exposed to an aerosol concentration of 1,8-naphthylendiamine at an analytical concentration of 0, 156, 413 or 877 mg/m³ (highest technical feasible concentration) for 4 hours. An exposition up to 877 mg/m³ 1,8-naphtylenediamine (highest technical feasible concentration) was tolerated without mortality.

Five male and five female Wistar rats were treated occlusively with a single application of 2000 mg/kg bw of 1,8-naphthylendiamine.

No death occured (LD50 > 2000 mg/kg bw).


Justification for selection of acute toxicity – oral endpoint
key study used

Justification for selection of acute toxicity – inhalation endpoint
key study used

Justification for selection of acute toxicity – dermal endpoint
key study used

Justification for classification or non-classification

Due to the results of the acute oral toxicity study (LD50 = 591 mg/kg bw for female rats) a classification as Xn, R22 (GHS: Acute tox. 4, H302) is justified.

For acute dermal and inhalation toxicity a classification is not justifed based on reliable experimental studies.