Registration Dossier
Registration Dossier
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EC number: 295-762-6 | CAS number: 92128-65-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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 adverse effect observed
- 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 available data onstream constituents benzene, cyclohexane and xylenes do not indicate reproductive toxicity of a severity that would warrant classification. However, n-hexane causes specific adverse effects on testes and thus is suspected to have effects on fertility, and toluene is classified as Rep Cat 2 (H361d) according to the CLP Regulation. Therefore, unless n-hexane or toluene are present, Aliphatics and Cyclics C5 and Higher streams are not considered to be reproductive toxicants and no classification or labelling is warranted.
n-Hexane (Classification: Category 2, H361): Testicular atrophy in male rats is seen after repeated dose oral or inhalation exposure to generally high doses of n-hexane which also produce peripheral neuropathy and other systemic effects.
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 (2261mg/m3) (Thiel and Chahoud, 1997).
Short description of key information:
It is recognised that there is a data gap for a multi-generation
study (REACH reference 8.7.3). The applicant submits that this study
does not need to be conducted as Aliphatics and Cyclics C5 and Higher
streams contain at least 0.1% benzene which are known to be mutagenic
and carcinogenic. The specific reproduction toxicity data on streams
within this category are limited to a single 4 week general toxicity and
reproduction/developmental toxicity screening study (OECD 422) by
inhalation exposure to rats with Pyrolysis C5 (CAS 68476-55-1). This
study showed no evidence of reproduction toxicity at the highest
concentration tested (1012 ppm). Data on the fertility of specific
components present in some streams indicate that only n-hexane possesses
specific effects which warrant labelling. Therefore for streams that
contain n-hexane at concentrations greater than or equal to 3%,
classification is required for effects on fertility.
Justification for selection of Effect on fertility via oral route:
n-Hexane, present in some streams, has been shown to adversely
affect fertility. However controls to protect against the
carcinogenicity of benzene (present in all streams at 0.1% and above)
will mitigate such risks to reproduction.
Justification for selection of Effect on fertility via inhalation
route:
n-Hexane, present in some streams, has been shown to adversely
affect fertility. However controls to protect against the
carcinogenicity of benzene (present in all streams at 0.1% and above)
will mitigate such risks to reproduction.
Justification for selection of Effect on fertility via dermal route:
n-Hexane, present in some streams, has been shown to adversely
affect fertility. However controls to protect against the
carcinogenicity of benzene (present in all streams at 0.1% and above)
will mitigate such risks to reproduction.
Effects on developmental toxicity
Description of key information
It is recognised that there is a data gap for a developmental toxicity study (REACH reference 8.7.2). The applicant submits that this study does not need to be conducted as Aliphatics and Cyclics C5 and Higher streams contain at least 0.1% benzene which are known to be mutagenic and carcinogenic. The specific developmental toxicity data on streams within this category are limited to a single 4 week general toxicity and reproduction/developmental toxicity screening study (OECD 422) by inhalation exposure to rats on Pyrolysis C5 (CAS 68476-55-1). This study showed no evidence of developmental toxicity at the highest concentration tested (1012 ppm). Data on the developmental toxicity of specific components present in some streams indicate that only toluene is recognised as possessing specific effects which warrant labelling. Therefore for streams that contain toluene at concentrations greater than or equal to 3%, classification is required for developmental toxicity.
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 developmental 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 developmental hazards of these streams after inhalation.
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the developmental hazards of these streams after skin contact
Additional information
The available data on the specific components benzene, cyclohexane and xylenes do not reveal developmental toxicity of a severity that would warrant classification. However, data on toluene indicate evidence of developmental toxicity at exposures of ≥ 1000 ppm. Therefore, unless toluene is present, Aliphatics and Cyclics C5 and Higher streams are considered not to be reproductive toxicants and no classification or labelling is warranted.
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 (2261mg/m3) (Thiel and Chahoud, 1997).
Justification for selection of Effect on developmental
toxicity: via oral route:
Toluene, present in some streams, has been shown to adversely affect
the foetus. However controls to protect against the carcinogenicity of
benzene (present in all streams at 0.1% and above) will mitigate such
risks to foetal development.
Justification for selection of Effect on developmental toxicity: via
inhalation route:
Toluene, present in some streams, has been shown to adversely affect
the foetus. However controls to protect against the carcinogenicity of
benzene (present in all streams at 0.1% and above) will mitigate such
risks to foetal development.
Justification for selection of Effect on developmental toxicity: via
dermal route:
Toluene, present in some streams, has been shown to adversely affect
the foetus. However controls to protect against the carcinogenicity of
benzene (present in all streams at 0.1% and above) will mitigate such
risks to foetal development.
Justification for classification or non-classification
The need for 2-generation reproduction toxicity and full developmental toxicity studies for Aliphatics and Cyclics C5 and Higher streams is waived as they are classified as mutagenic and carcinogenic. There are sufficient data available on component substances to conclude that streams within this class that contain less than 3% toluene or n-hexane are not reproductive toxicants and do not require a label for this endpoint. Aliphatic and Cyclic C5 and Higher streams which contain ≥ 3% toluene should be classified Category 2, H361d according to Reg (EC) 1272/2008. Streams that contain ≥ 5% toluene are classified Category 2, H361 according to Reg (EC) 1272/2008.
Additional information
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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