Registration Dossier

Administrative data

Description of key information

No repeated toxicity studies have been conducted for renewable hydrocarbons of wood origin (diesel type fraction). In stead, two dermal studies of read-across substances, a subacute (OECD 410) and a chronic study (non-guideline) are available. 
The reliable subacute test conducted for thermocracked kerosene showed the systemic NOAEL level of 0.5 mL/kg/day (400 mg/kg bw/day) based on the lack of systemic effects in the dose levels tested. The same study showed the local LOAEL of 0.01 mL/kg/day (8 mg/kg bw/day) based on the slight irritation (the lowest dose tested).
In the chronic study (non-giudeline) the composition of the test substance is not exactly known. Thus, the LOAELs established in the study for the tested substance are not considered relevant to characterise the hazard of renewable diesel.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
August 21, 1990 - September 18, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restriction because it was conducted to read-across substance. However, the study was conducted according to OECD TG 410 guideline and in accordance with GLP. Read-across justification: Based on the chemical composition, the renewable hydrocarbons produced from raw materials such as fatty acid rich oil like Crude Tall Oil (CTO) or triglyserides, using a hydrotreatment process have similar hydrocarbon fractions and they contain the same critical constituents than fossil diesel fuels. According to the identified hydrocarbon blocks, the typical carbon number ranges and the physicochemical properties, the renewable hydrocarbons with diesel type fractions can be considered as having structural similarities and similar behaviour in contact with water and in the physiological processes than the analogue source substances (fossil diesel fuels). Their irritation properties, skin sensitisation property as well as acute and long-term adverse effects to human health is similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from the analogue fossil diesel fuels is used to evaluate skin and eye irritation, the genetic toxicity, carcinogenicity, developmental toxicity and short term and/or long-term toxicological effects of the target substance
Qualifier:
according to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska
- Age at study initiation: Young adult
- Weight at study initiation: Males: 200 to 300 grams; Females: 125 to 200 grams
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
-Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26
- Humidity (%): 40 to 70%
- Air changes (per hr): 10 per hour or more
- Photoperiod (hrs dark / hrs light): 12 hour dark/ 12 hour light

IN-LIFE DATES: From:1990-08-20 To: 1990-09-18
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 10% of the body surface area
- Type of wrap if used: Latex dental damsecured in place with surgical adhesive tape
- Time intervals for shavings or clippings: As needed during the study

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was wiped from the application site
- Time after start of exposure: 6h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.05, or 0.5 ml/kg/day adjusted in accordance with the most recent body weight
- Constant volume or concentration used: no

USE OF RESTRAINERS FOR PREVENTING INGESTION: no
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
6 hours a day, 5 days a week
Remarks:
Doses / Concentrations:
0.01, 0.05, or 0.50 mL/kg/day
Basis:
nominal per unit body weight
No. of animals per sex per dose:
10
Control animals:
yes, concurrent no treatment
Details on study design:
- Dose selection rationale: Doses were selected based on a range-finding study.
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice a day
- Cage side observations checked for mortality and viability.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week

DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Five days a week just prior to application of the test article, 24 hours after the fifth application, and just prior to necropsy

BODY WEIGHT: Yes
- Time schedule for examinations: Prior to study initiation, three days a week (Monday, Wednesday, and Friday) throughout the dosing period, and at study termination

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: At study termination
- Anaesthetic used for blood collection: Yes (halothane)
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At terminal sacrifice
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined.

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

OTHER: Organ weight: Yes. Listed in table 1
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2)
Statistics:
Clinical pathology data, terminal organ weights, and organ to body weight ratios were statistically analyzed. Statistical evaluation of equality of means was done by an appropriate one way analysis of variance and a test for ordered response in the dose groups.
For the parametric procedures, a standard one way ANOVA using the F distribution to assess significance was used.
For the nonparametric procedures, the test of equality of means was performed using Kruskal-Wallis test.
Mean Draize irritation scores were plotted by group and time.
Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
no effects observed
Details on results:
CLINICAL SIGNS AND MORTALITY: There were no treatment-related effects on clinical signs (except dermal irritation) or mortality.

BODY WEIGHT AND WEIGHT GAIN: There were no treatment-related effects on body weight.

HAEMATOLOGY: There were no treatment-related effects on haematology.

CLINICAL CHEMISTRY: There were no treatment-related effects on clinical chemistry.

ORGAN WEIGHTS: There were no treatment-related effects on organ weights.

GROSS PATHOLOGY: At necropsy, the only findings occurred at the treatment site and included dry skin, oedema, and eschar.

HISTOPATHOLOGY: NON-NEOPLASTIC: At the dermal application sites (A and B) there were increased incidences of acanthosis, epidermal crusting, erosion, fibrosis, chronic inflammation, and hyperkeratosis.

OTHER FINDINGS: Dermal irritation occurred in treated animals.
0.01 mL/kg/day: Very slight erythema, slight eschar, and slight dried skin.
0.05 mL/kg/day: Very slight to moderate erythema, slight to moderate eschar, sporadic very slight to slight oedema, and slight to moderately dried skin.
0.50 mL/kg/day: Skin irritation was great enough that the application site changed. For the original site (site A), moderate to severe dermal irritation (erythema, eschar, oedema, dried skin, fissuring, and ulcerations) occurred with a maximum mean daily score of 8.2 in males and 8.1 in females out of a total of 17. These effects decreased after the test site was moved. Similar effects were noted at site B, but the maximum mean daily score was 5.2 in males and 5.4 in females.
Dose descriptor:
NOEL
Remarks:
local
Effect level:
< 0.01 other: ml/kg
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: dermal irritation
Dose descriptor:
NOEL
Remarks:
systemic
Effect level:
0.5 other: ml/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No systemic effects were noted at highest dose level studied.
Critical effects observed:
not specified
Conclusions:
Thermocracked kerosine was applied dermally at doses 0, 0.01, 0.05 and 0.50 mL/kg bw / day to rats for 28 days. The following NOELS were established: systemic NOEL of 0.50 mL/kg/day ( no effects observed at highest dose tested) and local NOEL of < 0.01 mL/kg/day (dermal irritation at application site).
Executive summary:
This study was conducted for the read-across substance, thermocracked kerosine. In a 28-day dermal toxicity study, the test substance was applied to the shaved skin of 10 Sprague-Dawley rats/sex/dose at dose levels of 0, 0.01, 0.05, or 0.5 mL/kg bw/day, 6 hours/day for 5 days/week during a 28-day period. The test compound irritated the skin in a dose-dependent manner. In the high-dose group, the irritation became severe so the application site was moved to a cephalad location at the beginning of the fourth week. There were no compound related effects in mortality, clinical signs, body weight, haematology, clinical chemistry, organ weights, or gross and histologic pathology (except the skin). The LOAEL for dermal irritation is 0.01 mL/kg/day, based on slight to severe dermal irritation occurring at all doses tested. No dermal irritation NOAEL was established. There was no systemic LOAEL, based on the lack of systemic effects. The systemic NOAEL is greater than or equal to 0.5 mL/kg/day.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
400 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
August 21, 1990 - September 18, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restriction because it was conducted to read-across substance. However, the study was conducted according to OECD TG 410 guideline and in accordance with GLP. Read-across justification: Based on the chemical composition, the renewable hydrocarbons produced from raw materials such as fatty acid rich oil like Crude Tall Oil (CTO) or triglyserides, using a hydrotreatment process have similar hydrocarbon fractions and they contain the same critical constituents than fossil diesel fuels. According to the identified hydrocarbon blocks, the typical carbon number ranges and the physicochemical properties, the renewable hydrocarbons with diesel type fractions can be considered as having structural similarities and similar behaviour in contact with water and in the physiological processes than the analogue source substances (fossil diesel fuels). Their irritation properties, skin sensitisation property as well as acute and long-term adverse effects to human health is similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from the analogue fossil diesel fuels is used to evaluate skin and eye irritation, the genetic toxicity, carcinogenicity, developmental toxicity and short term and/or long-term toxicological effects of the target substance
Qualifier:
according to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska
- Age at study initiation: Young adult
- Weight at study initiation: Males: 200 to 300 grams; Females: 125 to 200 grams
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
-Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26
- Humidity (%): 40 to 70%
- Air changes (per hr): 10 per hour or more
- Photoperiod (hrs dark / hrs light): 12 hour dark/ 12 hour light

IN-LIFE DATES: From:1990-08-20 To: 1990-09-18
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 10% of the body surface area
- Type of wrap if used: Latex dental damsecured in place with surgical adhesive tape
- Time intervals for shavings or clippings: As needed during the study

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was wiped from the application site
- Time after start of exposure: 6h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.05, or 0.5 ml/kg/day adjusted in accordance with the most recent body weight
- Constant volume or concentration used: no

USE OF RESTRAINERS FOR PREVENTING INGESTION: no
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
6 hours a day, 5 days a week
Remarks:
Doses / Concentrations:
0.01, 0.05, or 0.50 mL/kg/day
Basis:
nominal per unit body weight
No. of animals per sex per dose:
10
Control animals:
yes, concurrent no treatment
Details on study design:
- Dose selection rationale: Doses were selected based on a range-finding study.
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice a day
- Cage side observations checked for mortality and viability.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week

DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Five days a week just prior to application of the test article, 24 hours after the fifth application, and just prior to necropsy

BODY WEIGHT: Yes
- Time schedule for examinations: Prior to study initiation, three days a week (Monday, Wednesday, and Friday) throughout the dosing period, and at study termination

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: At study termination
- Anaesthetic used for blood collection: Yes (halothane)
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At terminal sacrifice
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined.

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

OTHER: Organ weight: Yes. Listed in table 1
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2)
Statistics:
Clinical pathology data, terminal organ weights, and organ to body weight ratios were statistically analyzed. Statistical evaluation of equality of means was done by an appropriate one way analysis of variance and a test for ordered response in the dose groups.
For the parametric procedures, a standard one way ANOVA using the F distribution to assess significance was used.
For the nonparametric procedures, the test of equality of means was performed using Kruskal-Wallis test.
Mean Draize irritation scores were plotted by group and time.
Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
no effects observed
Details on results:
CLINICAL SIGNS AND MORTALITY: There were no treatment-related effects on clinical signs (except dermal irritation) or mortality.

BODY WEIGHT AND WEIGHT GAIN: There were no treatment-related effects on body weight.

HAEMATOLOGY: There were no treatment-related effects on haematology.

CLINICAL CHEMISTRY: There were no treatment-related effects on clinical chemistry.

ORGAN WEIGHTS: There were no treatment-related effects on organ weights.

GROSS PATHOLOGY: At necropsy, the only findings occurred at the treatment site and included dry skin, oedema, and eschar.

HISTOPATHOLOGY: NON-NEOPLASTIC: At the dermal application sites (A and B) there were increased incidences of acanthosis, epidermal crusting, erosion, fibrosis, chronic inflammation, and hyperkeratosis.

OTHER FINDINGS: Dermal irritation occurred in treated animals.
0.01 mL/kg/day: Very slight erythema, slight eschar, and slight dried skin.
0.05 mL/kg/day: Very slight to moderate erythema, slight to moderate eschar, sporadic very slight to slight oedema, and slight to moderately dried skin.
0.50 mL/kg/day: Skin irritation was great enough that the application site changed. For the original site (site A), moderate to severe dermal irritation (erythema, eschar, oedema, dried skin, fissuring, and ulcerations) occurred with a maximum mean daily score of 8.2 in males and 8.1 in females out of a total of 17. These effects decreased after the test site was moved. Similar effects were noted at site B, but the maximum mean daily score was 5.2 in males and 5.4 in females.
Dose descriptor:
NOEL
Remarks:
local
Effect level:
< 0.01 other: ml/kg
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: dermal irritation
Dose descriptor:
NOEL
Remarks:
systemic
Effect level:
0.5 other: ml/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No systemic effects were noted at highest dose level studied.
Critical effects observed:
not specified
Conclusions:
Thermocracked kerosine was applied dermally at doses 0, 0.01, 0.05 and 0.50 mL/kg bw / day to rats for 28 days. The following NOELS were established: systemic NOEL of 0.50 mL/kg/day ( no effects observed at highest dose tested) and local NOEL of < 0.01 mL/kg/day (dermal irritation at application site).
Executive summary:
This study was conducted for the read-across substance, thermocracked kerosine. In a 28-day dermal toxicity study, the test substance was applied to the shaved skin of 10 Sprague-Dawley rats/sex/dose at dose levels of 0, 0.01, 0.05, or 0.5 mL/kg bw/day, 6 hours/day for 5 days/week during a 28-day period. The test compound irritated the skin in a dose-dependent manner. In the high-dose group, the irritation became severe so the application site was moved to a cephalad location at the beginning of the fourth week. There were no compound related effects in mortality, clinical signs, body weight, haematology, clinical chemistry, organ weights, or gross and histologic pathology (except the skin). The LOAEL for dermal irritation is 0.01 mL/kg/day, based on slight to severe dermal irritation occurring at all doses tested. No dermal irritation NOAEL was established. There was no systemic LOAEL, based on the lack of systemic effects. The systemic NOAEL is greater than or equal to 0.5 mL/kg/day.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
8
Study duration:
subacute
Species:
rat

Additional information

No study was conducted since there is enough evidence on repeated dose toxicity on the identified ingredients of the substance and two analogue read-across substances. This UVCB substance is a complex mixture of hydrocarbons. When there is no data of the substance itself the read-across data was also used to avoid unnecessary animal testing. The read-across from fossil diesel fuels and kerosenes is justified because of the similar composition, toxicokinetics and physical-chemical and toxicological properties of renewable diesel and read-across substances. The read-across justification and the data matrices are presented in annex 1 of the CSR.

Renewable hydrocarbons of wood origin (diesel type fraction) contains n-hexane < 2 % (w/w). N-hexane is classified toxic after repeated dermal exposure with harmonized C&L entry of STOT-RE2 H373. The specific concentration limit (SCL) of n-hexane triggering the classification of mixtures to hazard class STOT-RE2 is ≥ 5 %. The substance contains also trace amounts of benzene (<0.1 %). Benzene has harmonised classification entry of STOT-RE1. The generic concentration range of individual substance (classified as a Category 1) in CLP regulation which triggers the classification of mixtures to hazard class STOT-RE2 is 1.0 % < c < 10.0 %. Based on the CLP mixture rules no classification of the target UVCB substance is warranted.

Weight of evidence approach based on the read-across data was used to assess the hazard to health after repeated dermal exposure.

Chronic toxicity fossil diesel fuels (JP-5 jet fuel and marine diesel fuel) were investigated in a 2-year dermal study in mice (NTP/NIH 1986 cited in ATDSR, 1995). The study is considered reliable with several restrictions. The data are limited for each of these experiments because it was not specified whether the animals were protected against oral exposure and/or removal of the test material. Furthermore, the benzene content was higher in these read-across substances than in renewable hydrocarbons of wood origin (diesel type fraction).

Groups of 50 mice of each sex were administered 0, 250, or 500 mg/kg both diesel fuels in acetone by dermal application, 5 days per week for 103 weeks (90 weeks for high dose female mice exposed to JP-5). Animals were observed for mortality and clinical signs during the study. At the end of the study period animals were subjected to histopathological examination. The results describe increase in incidence of dermatitis in mice in a dose dependent manner. Furthermore, under conditions of these studies, marine diesel fuel at doses of 250 and 500 mg/kg resulted in dose-related increased incidences of squamous cell neoplasms of the skin (primarily carcinomas), providing equivocal evidence of carcinogenicity for male and female B6C3F1 mice. Further investigation utilizing other species is required to more fully elucidate the mechanism of dermal carcinogenesis and the impact of dermal exposure of fuel oils on humans. The local and systemic LOAEL is 250 mg/kg bw/day, based on the dermal irritation occurring at all doses tested. No systemic or local NOAELs were established.

In a good quality GLP compliant study, toxicity of thermocracked kerosene was studied. The test substance was applied for 28 days to the shaved skin of 10 Sprague-Dawley rats/sex/dose at dose levels of 0, 0.01, 0.05, or 0.5 mL/kg bw/day, 6 hours/day for 5 days/week. The test compound irritated the skin in a dose-dependent manner. In the high-dose group, the irritation became severe so the application site was moved to a cephalad location at the beginning of the fourth week. There were no compound related effects in mortality, clinical signs, body weight, haematology, clinical chemistry, organ weights, or gross and histologic pathology (except the skin). The LOAEL for dermal irritation is 0.01 mL/kg/day (8 mg/kg bw/day), based on slight to severe dermal irritation occurring at all doses tested. No dermal irritation NOAEL was established. There was no systemic LOAEL, based on the lack of systemic effects. The systemic NOAEL is greater than or equal to 0.5 mL/kg/day (400 mg/kg bw/day).

The observed local effect (skin irritancy) in the study is covered by the respective classification. The classification for skin irritation is based on the in vitro study conducted for the substance itself and on the in vivo study conducted for the read-across substance.

In conclusion, the available information of the read-across substances indicates that there is no need to classify this UVCB substance as harmful to human health after prolonged exposure.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
No study conducted for the substance and no studies available for the read-across substances.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
No study conducted for the substance and no studies available for the read-across substances with respect to chronic inhalation hazard. Inhalation is not considered as relevant route of exposure.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
No study conducted for the substance and no studies available for the read-across substances with respect to chronic inhalation hazard.Inhalation is not considered as relevant route of exposure.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
No study conducted for the substance. The selected study is a good quality study conducted for the read-across substance, thermocracked kerosene. The dermal route is considered the most relevant route of human exposure.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
No study conducted for the substance. The selected study is a good quality study conducted for the read-across substance, thermocracked kerosene.

Justification for classification or non-classification

Based on the available data on the surrogate fossil fuels, renewable hydrocarbons of wood origin (diesel type fraction) is not classified under the CLP Regulation (EC No. 1272/2008 ) and according to EU Directive 67/548/EEC.