Registration Dossier

Administrative data

Description of key information

Irritation:
- skin: corrosive
- eye: corrosive
- respiratory system:

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation:

Full-thickness skin necrosis of the rabbit dorsal skin was found at eight days after open skin contact for 5 or 15 minutes with undiluted TDA. After a contact time of 1 minute, only superficial necrosis, but severe erythema and edema were still present at 8 days after the exposure (BASF AG, 1970; Val. 2).

 

Eye Irritation:

Severe reddening, very severe edema, and severe corneal opacity were noted in the rabbit eye at 1 and 24 hours after instillation of a small volume (0.05 ml) of an undiluted TDA. After 8 days, strong edema and suppuration did not allow examination of the eyes and the study was terminated for the sake of animal welfare (BASF AG, 1970; Val. 2).

Respiratory Tract Irritation

The sensory irritation potential of TDA was studied with the mouse bioassay following the method of the American Society for Testing and Materials (BASF AG, 1998; Val. 2). Groups of 4 male Swiss mice were exposed head-only to TDA (3.8, 7.7, 23 and 90 mg/m3) for 45 minutes, followed by a recovery phase of 15 minutes and a 7 day post-exposure observation period. Breathing patterns and frequency were recorded pre-exposure and during exposure in whole-body plethysmographs and the concentrations that produced a 50% decrease in frequency rates (RD50) during early, middle, and late 10-minute exposure intervals were calculated from the dose response. Clinical signs were only seen in the groups exposed to 23 or 90 mg/m³ (piloerection, poor condition of animals, and - at 90 mg/m3 only - labored breathing). The RD50s were calculated to be 525.6 mg/m3, 37.4 mg/m3 and 30.4 mg/m3 for the early, middle and late exposure periods, respectively. The respiratory depression was not fully reversible after the recovery phase at any of the tested concentrations. From the pattern of RD50 and the macroscopic lung findings in 2 mice exposed to 90 mg/m3 (focal red discoloration in some lobes of the lung), it was concluded that tridecylamine leads mainly to pulmonary irritation.

 


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

TDA was corrosive to the rabbit skin and eye. EU classification according to Annex VI of Directive 67/548/EEC: C; R34