Distillates (petroleum), heavy steam-cracked

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

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

Effect on fertility: via inhalation route

Endpoint conclusion:

no adverse effect observed

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

EDS fuel oil was included in the ACC review (ACC, 2005) and was considered to be of sufficiently similar composition to Fuel Oils streams to be used for read-across.

EDS Fuel Oil was investigated for reproductive toxicity in Sprague-Dawley rats. Animals were dosed by gavage at 0, 20, 100 or 500 mg/kg 5 days/week for 13 weeks prior to mating. Resulting pregnant females were allowed to litter and then dams and pups were killed on day 21 of lactation.There were no effects on pregnancy rate, no significant differences in frequency of fertilisation and implantation, length of gestation period or maternal weight gain during gestation. The NOAEL was 500 mg/kg bw/day.

The specific components benzene, toluene, ethylbenzene, styrene, naphthalene and anthracene do not reveal reproductive toxicity of a severity that would warrant classification.

Short description of key information:
It is recognised that there is a data gap for a multi-generation study (REACH reference 8.7.3). However, the need for a 2-generation reproduction toxicity is waived as it is proposed that Fuel Oils streams are classified as mutagenic and carcinogenic. There are limited reproduction toxicity data available for streams within this category. However, there are sufficient data on component substances to indicate that no further testing is warranted and no classification is required with respect to effects on fertility.

Justification for selection of Effect on fertility via oral route:
While only limited reproductive toxicity data are available for members of this category, information on the component substances present indicates they are unlikely to affect fertility. In addition, controls to protect against carcinogenicity will further mitigate any risk to reproduction.

Justification for selection of Effect on fertility via inhalation route:
While only limited reproductive toxicity data are available for members of this category, information on the component substances present indicates they are unlikely to affect fertility. 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 a developmental toxicity study (REACH reference 8.7.2). However, the need for a full developmental toxicity study is waived as it is proposed that Fuel Oils streams are classified as mutagenic and carcinogenic. There are limited data concerning developmental toxicity of streams within this category. Data on the developmental toxicity of specific components present in some streams indicate that toluene  possesses specific effects which warrant labelling. Therefore there are sufficient data on component substances to indicate that no further testing is warranted and that for streams containing <3% toluene no classification is required with respect to developmental toxicity.

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

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no adverse effect observed

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

EDS fuel oil was included in the ACC review (ACC, 2005) and was considered to be of sufficiently similar composition to Fuel Oils streams to be used for read-across

EDS Fuel Oil was dosed to pregnant Sprague-Dawley rats on days 6 -19 of gestation. The rats were killed on day 20 of gestation and the uterine contents examined. Maternal body weight and uterine weight were reduced at 500 and 1000 mg/kg. At these dose levels there was a dose-related decrease in the number of live foetuses and intrauterine growth was retarded in foetuses which survived to day 20 of gestation. There was no evidence of teratogenicity at any dose level (although a thorough evaluation was not possible due to the limited numbers of foetuses at the 1000 mg/kg dose level). The NOAEL for maternal and developmental effects was 100 mg/kg/day.

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

Justification for selection of Effect on developmental toxicity: via oral route:
While only limited developmental toxicity data are available for members of this category, information on the component substances present indicates they are unlikely to affect the foetus. In addition, controls to protect against carcinogenicity will further mitigate any risk to reproduction. Streams containing ≥ 3% toluene will require classification.

Justification for selection of Effect on developmental toxicity: via inhalation route:
While only limited developmental toxicity data are available for members of this category, information on the component substances present indicates they are unlikely to affect the foetus. In addition, controls to protect against carcinogenicity will further mitigate any risk to reproduction. Streams containing ≥ 3% toluene will require classification.

Justification for classification or non-classification

The need for 2-generation reproduction toxicity and full developmental toxicity studies for Fuel Oils streams is waived as it is proposed that 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 are not reproductive or developmental toxicants and do not require a label for these endpoints.

Fuel Oils streams which contain ≥ 3% toluene should be classified Category 2, H361d “Suspected of damaging the unborn child” according to Reg (EC) 1272/2008.