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Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Remarks:
other: expert assessment
Type of information:
other: expert assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.
Qualifier:
no guideline available
Principles of method if other than guideline:
An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.
GLP compliance:
no
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: The maximum tolerated dose in almost all studies and reviews
Reproductive effects observed:
not specified

This is not an exhaustive review of all oil types considered similar to the UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped but the weight of evidence from review publications and other public sources suggest that there is a low risk of reproductive and developmental effects. There is no evidence across the range of oils reviewed to show that repeated dermal application leads to developmental toxicity at levels tolerated by parental rats.

Very limited data on oral or inhalation exposure that relate to reproductive or developmental endpoints have been found, but it is recognised that dermal exposure is not only the most relevant for human exposure.

The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals; at dose levels in excess of 100 mg/kg/day, there are indications of reduced food intake and reduced weight and at higher dose levels, up to the maximum reported 1000 mg/kg/day, there is decreasing size of foeti and pups and in some cases, increase in the number of resorptions. The developmental observations are considered to be related to parental toxicity.

In the review of known components, it was not possible to find data on every specific component, but component types were assessed. Only toluene is known to have effects on development, and this is at high levels of exposure. Toluene is present at less than 1% in the substance to be registered and is not considered to influence the overall classification.

It is not considered acceptable to perform further reproduction toxicity tests on UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped in view of the wealth of data on similar light oils with high aromatic content.

Conclusions:
The evidence indicates that the oil is unlikely to cause toxicity to the reproduction via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity.
Executive summary:

An assessment of the toxicity to the reproduction of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic to reproduction. The evidence indicates that the oil is unlikely to cause reproductive toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

An assessment of the toxicity to the reproduction of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic to reproduction. The evidence indicates that the oil is unlikely to cause reproductive toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity.


Short description of key information:
The evidence indicates that the oil is unlikely to cause toxicity to the reproduction via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity. Limited data was available via the inhalation and oral route, but it is recognised that exposure to the oil will not be via the dermal route alone.

Justification for selection of Effect on fertility via dermal route:
An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.

Effects on developmental toxicity

Description of key information
The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity. Limited data was available via the inhalation and oral route, but it is recognised that exposure to the oil will not be via the dermal route alone.
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance.
GLP compliance:
no
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Abnormalities:
not specified
Developmental effects observed:
not specified

This is not an exhaustive review of all oil types considered similar to the UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped but the weight of evidence from review publications and other public sources suggest that there is a low risk of reproductive and developmental effects. There is no evidence across the range of oils reviewed to show that repeated dermal application leads to developmental toxicity at levels tolerated by parental rats.

Very limited data on oral or inhalation exposure that relate to reproductive or developmental endpoints have been found, but it is recognised that dermal exposure is not only the most relevant for human exposure.

The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals; at dose levels in excess of 100 mg/kg/day, there are indications of reduced food intake and reduced weight and at higher dose levels, up to the maximum reported 1000 mg/kg/day, there is decreasing size of foeti and pups and in some cases, increase in the number of resorptions. The developmental observations are considered to be related to parental toxicity.

In the review of known components, it was not possible to find data on every specific component, but component types were assessed. Only toluene is known to have effects on development, and this is at high levels of exposure. Toluene is present at less than 1% in the substance to be registered and is not considered to influence the overall classification.

It is not considered acceptable to perform further reproduction toxicity tests on UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped in view of the wealth of data on similar light oils with high aromatic content.

Conclusions:
The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity.
Executive summary:

An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic for reproduction. The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic for reproduction. The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity. Limited data was available via the inhalation and oral route, but it is recognised that exposure to the oil will not be via the dermal route alone.


Justification for selection of Effect on developmental toxicity: via dermal route:
An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.

Justification for classification or non-classification

The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Additional information

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