Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
Subject to approval by ECHA

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Reference substance name:
Tank fume condensate derived from Residues (petroleum), thermal cracked vacuum (CAS No 92062-05-0)
IUPAC Name:
Tank fume condensate derived from Residues (petroleum), thermal cracked vacuum (CAS No 92062-05-0)
Details on test material:
Based on historical data, the proposed test material (worst case approach) is a liquid condensate collected from the headspace of a heated tank of Residues (petroleum), thermal cracked vacuum (CAS No 92062-05-0): A complex combination of hydrocarbons obtained from the vacuum distillation of the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C34 and boiling above approximately 495°C (923°F). More information on the worst case approach in sample selection is provided in the testing proposal.

Remark: Study proposal to meet REACH Annex X (8.7.2) requirements.

Test animals

Species:
rat

Administration / exposure

Route of administration:
inhalation
Details on study design:
Species: Rat. Female
Route: Inhalation (aerosol/vapour mix from tank fume condensate)
Doses: 3 levels, controlling for respiratory tract irritation
Species: Rat. Female

Route: Inhalation (aerosol/vapour mix from tank fume condensate)

Doses: 3 levels, controlling for respiratory tract irritation

Test Material: Based on historical data, the proposed test material (worst case approach) is a liquid condensate collected from the headspace of a heated tank of Residues (petroleum), thermal cracked vacuum (CAS No 92062-05-0): A complex combination of hydrocarbons obtained from the vacuum distillation of the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C34 and boiling above approximately 495°C (923°F). More information on the worst case approach in sample selection is provided in the testing proposal.

Remark: Study proposal to meet REACH Annex X (8.7.2) requirements.

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion