Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

There are no many data available on 2-chloro-5-nitrobenzoic acid, thus a read across on structural analogues approach has been evaluated in order to outline an (eco)toxicological profile most complete as possible and to elaborate an appropriate C&L.

Substances considered for read across are 4-chloro-3-nitrobenzoic acid (CAS: 96-99-1; EC: 202-550-9) and 3-nitrobenzoic acid (CAS: 121-92-6; EC: 204-508-5).

 

Considering all data available, it is expected that 2-chloro-5-nitrobenzoic acid is a skin sensitizer (Skin Sens 1, H317) and an eye irritant (Eye Irrit. 2, H319).

Both eye irritation and skin sensitization were evaluated through the comparing with the outcomes on the analogue 4 -chloro-3 -nitrobenzoic acid. In the first case substance showed adverse effects lasting more than 21 days as moderate redness, swelling of the conjunctiva, reddening of the iris and corneal cloudiness. In the case of skin sensitization, it was evaluated by Mouse Local Lymphnode Assay (LLNA) test that resulted positive.

No concern for acute and repeated dose toxicity has been reported.

Mutagenicity was investigated by both in vitro and in vivo tests: in the first case some positive results were reported, but they were not confirmed by the in vivo outcomes, that reported no genetic toxicity effects.

In the studies on reproductive toxicity some adverse effects on fertility were observed; nevertheless it has to be considered that substance was tested at dosage so high that a reliable conclusion can not be drawn.

Any details about data available are reported in the report attached at the point 13: Assessment Report.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

There are no concern for genaral population. because 2-chloro-5-nitrobenzoic acid is a pharmacautical intermediate, thus it is not expected that a contact with the substance can occur.