REACH studies

REACH & INDUSTRIAL CHEMICALS

In the pharmaceutical industry, compliance with the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulations is crucial. These regulations, overseen by the European Chemical Agency (ECHA), are instrumental in ensuring the safety and environmental impact of industrial chemicals used in pharmaceutical processes. Adgyl Life Sciences helps actively support and facilitate adherence to REACH requirements, enhancing the pharmaceutical sector’s commitment to safety and compliance.

As a trusted partner in the pharmaceutical industry, Adgyl Life Sciences takes the lead in providing comprehensive REACH Studies, aligning with the regulatory requirements set forth by the European Chemical Agency (ECHA).

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Studies) is a regulatory requirement of European Chemical Agency (ECHA). It requires that all companies manufacturing or importing chemical substances into the European Union in quantities of one ton or more per year to register these substances with ECHA. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.

Adgyl Lifesciences has experience and expertise in designing the REACH studies as per European Chemical Agency (ECHA) requirements. Adgyl has completed more than 100 REACH packages and submitted to Agency in the International Uniform Chemical Information Database (IUCLID) format.

Annex VII (1 Tonne or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406) or
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)

Annex VIII (10 Tonnes or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406) or
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)
28 Day Repeated Dose (OECD 407)
Reproductive Toxicity (OECD 421)
Developmental Toxicity study (OECD 414)

Annex IX (100 Tonnes Or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
Mammalian Erythrocyte Micronucleus Test (OECD 474)
Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406)
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429) or
90 Day Repeated Dose (OECD 408)
Reproductive Toxicity (OECD 421)
Developmental Toxicity Study-Rats (OECD 414)
Extended One-Generation Reproduction Toxicity Study in Rats (OECD 443)

Annex X (1000 Tonnes or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
Mammalian Erythrocyte Micronucleus Test (OECD 474)
Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406) or
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)
90 Day Repeated Dose (OECD 408)
Reproductive Toxicity (OECD 421)
Developmental Toxicity Study-Rats & Rabbits (OECD 414)
Extended One-Generation Reproduction Toxicity Study in Rats (OECD 443)
Chronic Toxicity (OECD 452)/ Carcinogenicity (Oncogenicity) (OECD 451)