Registration Dossier

Diss Factsheets

Administrative data

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.

Data source

Reference
Reference Type:
other: expert assessment
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped
EC Number:
941-627-8
Molecular formula:
Not Applicable
IUPAC Name:
Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped
Constituent 2
Reference substance name:
Not assigned
IUPAC Name:
Not assigned
Test material form:
other: Liquid
Details on test material:
Name: Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.

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