Registration Dossier

Diss Factsheets

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

It is recognised that there is a data gap for an Extended One-Generation Reproductive Toxicity study (REACH reference 8.7.3). The applicant submits that this study does not need to be conducted as Fuel Oils streams are expected to contain at least 0.1% benzene which is known to be mutagenic Category 1B and carcinogenic Category 1A or are classified as carcinogenic Category 1B under CLP/GHS ,and therefore appropriate risk management measures are implemented (handled incontrolled conditions).

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Adequate information is available on the component substances to characterise the reproductive hazards of these streams after ingestion.
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Adequate information is available on the component substances to characterise the reproductive hazards of these streams after inhalation.
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Quality of whole database:
Adequate information is available on the component substances to characterise the reproductive hazards of these streams after skin contact.
Additional information

The specific stream marker constituents: benzene, toluene, ethylbenzene, styrene, naphthalene and anthracene do not reveal reproductive toxicity of a severity that would warrant classification. Reproductive Toxicity Category 2 (H361) self-classification is applied to DCPD based on the WoE on a number of studies that suggest that it produced foetotoxic effects at doses at or below those that produced clear signs of maternal toxicity.


The following information is taken into account for any hazard / risk assessment:

It is recognised that there is a data gap for an Extended One-Generation Reproductive Toxicity study (REACH reference 8.7.3). The applicant submits that this study does not need to be conducted as Fuel Oils streams are expected to contain at least 0.1% benzene which is known to be mutagenic Category 1B and carcinogenic Category 1A or are classified as carcinogenic Category 1B under CLP/GHS.


Justification for selection of Effect on fertility via oral route:
Information on the constituents of the Fuel Oils streams indicates that some are likely to affect fertility, however, such constituents will not reach the concentrations that warrant classification. In addition, controls to protect against carcinogenicity will further mitigate any risk to reproduction.

Justification for selection of Effect on fertility via inhalation route:

Information on the constituents of the Fuel Oils streams indicates that some are likely to affect fertility, however, such constituents will not reach the concentrations that warrant classification. In addition, controls to protect against carcinogenicity will further mitigate any risk to reproduction.

Justification for selection of Effect on fertility via dermal route:

Information on the constituents of the Fuel Oils streams indicates that some are likely to affect fertility, however, such constituents will not reach the concentrations that warrant classification. In addition, controls to protect against carcinogenicity will further mitigate any risk to reproduction.

Effects on developmental toxicity

Description of key information

It is recognised that there is a data gap for an Extended One-Generation Reproductive Toxicity study (REACH reference 8.7.3). The applicant submits that this study does not need to be conducted as Fuel Oils streams are expected to contain at least 0.1% benzene which is known to be mutagenic Category 1B and carcinogenic Category 1A or are classified as carcinogenic Category 1B under CLP/GHS ,and therefore appropriate risk management measures are implemented (handled in controlled conditions).

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Species:
rabbit
Abnormalities:
not specified
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Adequate information is available on the component substances to characterise the reproductive hazards of these streams after ingestion.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Adequate information is available on the component substances to characterise the reproductive hazards of these streams after inhalation.
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Quality of whole database:
Adequate information is available on the component substances to characterise the reproductive hazards of these streams after skin contact.
Additional information

Available data on the specific stream marker constituents: benzene, ethylbenzene, styrene, naphthalene and anthracene indicate no hazard with respect to developmental toxicity and no labelling is warranted.

Reproductive Toxicity Category 2 (H361) self-classification is applied to DCPD based on the WoE on a number of studies that suggest that it produced developmental effects at doses at or below those that produced clear signs of maternal toxicity.

Data on toluene indicates evidence of developmental toxicity:

Toluene (Classification: Category 2, H361d): There is no evidence that toluene produces malformation in animals or humans. There is some evidence of developmental toxicity (lower body weight at birth and delayed vaginal opening) at toluene exposure concentrations ≥ 1000 ppm, concentrations which are associated with slight maternal toxicity. The NOAEC for developmental and maternal effects is 600 ppm (2261 mg/m3) (Thiel and Chahoud, 1997).

Styrene (Classification: Category 2, H361d): Styrene is classified in Annex VI of the CLP regulation as suspected of being damaging the unborn child.


Justification for selection of Effect on developmental toxicity: via oral route:

Information on the constituents of the Fuel Oils streams indicates that some are likely to affect the foetus, however, such constituents will not reach the concentrations that warrant classification. In addition, controls to protect against carcinogenicity will further mitigate any risk to foetal development.

Justification for selection of Effect on developmental toxicity: via inhalation route:

Information on the constituents of the Fuel Oils streams indicates that some are likely to affect the foetus, however, such constituents will not reach the concentrations that warrant classification. In addition, controls to protect against carcinogenicity will further mitigate any risk to foetal development.

Justification for selection of Effect on developmental toxicity: via dermal route:

Information on the constituents of the Fuel Oils streams indicates that some are likely to affect the foetus, however, such constituents will not reach the concentrations that warrant classification. In addition, controls to protect against carcinogenicity will further mitigate any risk to foetal development.


Justification for classification or non-classification

The constituents classified as Reproductive toxicants (Category 2) are not present at ≥3%, however, Fuel Oils streams that contain ≥0.3% of isomer of butyltoluene should be classified as Reprodutive Category 1A (H360) according to Reg (EC) 1272/2008.

Additional information