Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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, biphenyl 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.

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 <5% (EU/DPD) [or <3% GHS/CLP] toluene no classification is required with respect to developmental toxicity.
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, biphenyl 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: EU – Harmful Xn, R63; GHS/CLP – 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 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 5% (EU/DPD) or 3% (GHS/CLP) 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. Fuel Oils streams that contain ≥ 5% toluene are classified: Xn, Cat 3 R63 “Possible risk of harm to unborn child” according to Dir 1999/45/EC.