Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.297 mg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
70
Modified dose descriptor starting point:
NOAEC
DNEL value:
440.789 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
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:
DNEL (Derived No Effect Level)
Value:
3.571 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
70
Modified dose descriptor starting point:
NOAEL
DNEL value:
250 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Toxicokinetics:

The chemicalbiphenyl-2-ylamine (Synonym -2-aminobiphenyl) CAS No 90-41-5 was administered intra-peritoneally to 4 rodent species namely albino mice, Wistar albino rats, Syrian golden hamsters, and albino Dunkin-Hartley guinea pigs. The results of the metabolism and excretion indicate that after metabolism, 40 to 50 % chemical is excreted out of the living system via renal elimination within 5 days. This suggests that the chemical biphenyl-2-ylamine (Synonym -2-aminobiphenyl) shall have low bioaccumulation potential. The study also concludes that the chemical is relatively non-toxic given its failure to be converted to N-oxidation products.

Acute Toxicity (Oral, Dermal, Inhalation):

On the basis of available studies, the substance 2 biphenylamine is classified in Acute toxicity category 4 by oral route only. This is in agreement with the Harmonized classification of this chemical in the CLP inventory.

Irritation effect (Skin & Eye):

Based upon the available information, the chemical biphenyl-2-ylamine is not classified as a Skin irritation and Eye Irritation.

Skin sensitization:

The test substance biphenyl-2-ylamine was estimated to be non-sensitising to skin of human and Guinea pig. Considering the CLP criteria for classification of substances, it is concluded that biphenyl-2-ylamine is likely to be classified as not sensitizing to the human and Guinea pig skin.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.553 mg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEC
DNEL value:
217.391 mg/m³
AF for intraspecies differences:
10
Justification:
general population default
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:
DNEL (Derived No Effect Level)
Value:
1.786 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEL
DNEL value:
250 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
General population default
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.893 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEL
DNEL value:
125 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
general population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL derivation

The available data indicates that the test substance biphenyl-2 -ylamine is classified as Acute Oral category 4 only as per the Harmonized CLP classification.

Available data also indicates that the chemical is not likely to exhibit genotoxicity or toxic effects to reproduction. However, this chemical has a Harmonized Classification of Carcinogen Category 2. Administration of 2-biphenylamine resulted in the formation of erythroid hyperplasia and transitional cell hyperplasia in male and female rats. Hyperplasia is defined as the enlargement of an organ or tissue caused by an increase in the reproduction rate of its cells, often as an initial stage in the development of cancer.

A standard approach to deriving DNEL values has been to use the carcinogenecity dataset (oral route) and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 500 mg/kg bw/d in oral category.