Registration Dossier
Registration Dossier
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EC number: 201-990-9 | CAS number: 90-41-5
Toxicological Summary
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
- 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
- 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
- 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
- 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
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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