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Examples for EU Regulations embracing datasharing

EFSA: Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition:
“The fact that a study is published as part of an application dossier on Open.EFSA for transparency reasons does not allow other applicants to use it without consent by the study holder. Applicants must secure the necessary rights for regulatory use with the owner of the study by means of a “Letter of Access” or by means of specific contractual arrangements of some sort. On this matter, applicants are invited to refer to Article 20 of Regulation EC 1831/2003 on data protection (and on sharing of information in order not to repeat toxicological tests in vertebrates), and to consult with the European Commission in case an agreement on data sharing with the previous applicant would not be reached.” (EFSA personal communication, 02/2023)
ECHA: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH):
“Registrants must make every effort to share data on the intrinsic substance properties in a fair, transparent and non-discriminatory way. This applies in particular to information involving tests on vertebrate animals. By doing this, the registrants reduce registration costs and avoid unnecessary testing, especially on vertebrate animals. If parties cannot reach an agreement, ECHA can help to resolve data- sharing disputes as a last resort.” (cited from ECHA homepage as visited 03/2024: https://echa.europa.eu/regulations/reach/reg istration/data-sharing)
Acute inhalation toxicity test

(e.g. after OECD Test Guideline 403)

Acute dermal irritation/Corrosion

(e.g. after OECD Test Guideline 404)

In vivo eye irritation/Serious eye damage

(e.g. after OECD Test Guideline 405)

Skin sensitisation

(e.g. after OECD Test Guideline 406)

Repeated dose 28-day oral toxicity study in rodents

(e.g. after OECD Test Guideline 407)

Repeated dose 90-Day oral toxicity study in rodents

(e.g. after OECD Test Guideline 408)

Repeated dose 90-Day oral toxicity study in non-rodents

(e.g. after OECD Test Guideline 409)

Subacute Inhalation Toxicity: 28-day study

(e.g. after OECD Test Guideline 412)

Subchronic Inhalation Toxicity: 90-day study

(e.g. after OECD Test Guideline 413)

Prenatal developmental toxicity study

(e.g. after OECD Test Guideline 414)

Two-Generation reproduction toxicity

(e.g. after OECD Test Guideline 416)

Absorption, distribution, metabolism and excretion (ADME). Toxicokinetics/dynamics test

(e.g. after OECD Test Guideline 417)

Reproduction/Developmental toxicity screening test

(e.g. after OECD Test Guideline 421)

Skin sensitisation – Local lymph node assay

(e.g. after OECD Test Guideline 429)

In vitro skin corrosion: Transcutaneous electrical resistance test method (TER)

(e.g. after OECD Test Guideline 430)

In vitro skin corrosion: Reconstructed human epidermis (RhE) test method

(e.g. after OECD Test Guideline 431)

Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants

(e.g. after OECD Test Guideline 437)

In vitro skin irritation: reconstructed human epidermis test method

(e.g. after OECD Test Guideline 439)

Extended one-generation reproductive toxicity study

(e.g. after OECD Test Guideline 443)

Chronic toxicity study

(e.g. after OECD Test Guideline 452)

Combined chronic toxicity/carcinogenicity studies

(e.g. after OECD Test Guideline 453)

Bacterial reverse mutation test

(e.g. after OECD Test Guideline 471)

In vitro mammalian chromosomal aberration test

(e.g. after OECD Test Guideline 473)

In vivo mammalian erythrocyte micronucleus test

(e.g. after OECD Test Guideline 474)

In vivo mammalian bone marrow chromosomal aberration test

(e.g. after OECD Test Guideline 475)

In vitro mammalian cell micornucleus test

(e.g. after OECD Test Guideline 487)

Transgenic rodent somatic and germ cell gene mutation assays

(e.g. after OECD Test Guideline 488)

In vivo mammalian alkline comet assay

(e.g. after OECD Test Guideline 489)

Others