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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 May - 19 June 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
Molecular formula:
Substance is a UVCB and cannot be defined by molecular and structural information
IUPAC Name:
Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
Test material form:
liquid
Specific details on test material used for the study:
Batch No: 02 November 2020

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 161.15 g to 178.85 g
- Fasting period before study: fasted overnight (16 to 18 hours)
- Housing: Three animals were housed in standard polysulphonate cage (Size: L 430 x B 280 x H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.

- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Healthy young adult animals used for Sighting Study I, Sighting Study II and Main Study were acclimatized for five, seven and nine days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily.
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6°C to 22.8°C
- Humidity (%): 46% to 64%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle.

IN-LIFE DATES: From: 19 May To: 7/06/2021

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 5 ml
- Justification for choice of vehicle: As per the in-house miscibility test, test item is miscible in corn oil. Corn oil is universally accepted and routinely used vehicle in oral toxicity studies.
- Lot/batch no. (if required): N12009002


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

- Rationale for the selection of the starting dose: A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight because of unavailability of sufficient toxicological data on the test item
Doses:
The test item was administered through oral gavage as a single dose of 300 mg/kg body weight to one female rat in Sighting study I. No clinical signs of toxicity and mortality was observed. Hence, as per the decision rules governing the sequential procedure presented in the OECD 420 test guideline, Sighting Study II was conducted using one female rat after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed. Hence, Main study was conducted using four female rats after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed.
Dose levels higher than 2000 mg/kg body weight were not tested.
No. of animals per sex per dose:
1 animal for sighting study at 300 mg/kg bw
5 animals for main studyat 2000 mg/kg bw
Total of 6 females were received.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period.
- Necropsy of survivors performed: yes, at the end of observation period, all the surviving animals were sacrificed under carbon dioxide asphyxiation, subjected to necropsy and a complete gross pathological examination and the observations were recorded. Observations included changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern.
- Clinical signs including body weight : Individual animal body weight was recorded at receipt, on day 1 (before test item administration) and on days 8 and day 15 during the observation period.
- Other examinations performed: Histopathological examination was not carried out as there were no gross lesions observed.

Results and discussion

Preliminary study:
The test item was administered through oral gavage as a single dose of 300 mg/kg body weight to one female rat in Sighting study I. No clinical signs of toxicity and mortality was observed.
,Sighting Study II was conducted using one female rat after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed.
Main study was conducted using four female rats after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
other: No clinical signs of toxicity and mortality were observed in any of the dosed animals.
Gross pathology:
No gross pathological changes were observed in any of the dosed animals.
Other findings:
N/A

Any other information on results incl. tables

TABLE 1. INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD






















































































































































































Study Steps


&


Dose


(mg/kg body weight)



Animal No.



Sex



Time of Dosing (AM)



Clinical Signs of Toxicity and Mortality on


Day 1



Clinical Signs of Toxicity and Mortality on Day



20 to 30


min



1 hr


(±10 min)



2hrs


(±10 min)



3hrs


(±10


min)



4hrs


(±10


min)



2



3



4



5



6



7



8



9



10



11



12



13



14



15



Sighting Study I                     &                          300



Rf6896



F



11:16



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Sighting Study II                   &                       2000



Rf6897



F



11:08



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Main Study      &                      2000



Rf6898



F



10:53



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Rf6899



F



10:53



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Rf6900



F



10:53



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Rf6901



F



10:54



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N: Normal; F: Female; min/mins: minutes; hr/hrs: Hour/Hours


 


TABLE 2. INDIVIDUAL ANIMAL BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1



















































































































Study Steps


&


Dose


(mg/kg body weight)



Animal No.



Sex



Volume Administered (mL)



Body Weight (g) on Day



Percent Change in Body Weight with Respect to Day



1



8



15



 



1 to 8



1 to 15



Sighting Study I &                                300



Rf6896



F



1.6



158.00



181.06



204.18



 



14.59



29.23



Sighting Study II &                             2000



Rf6897



F



1.6



155.78



175.10



193.02



 



12.40



23.91



Main Study                      &                            2000



Rf6898



F



1.6



157.02



170.15



192.09



 



8.36



22.33



Rf6899



F



1.6



163.99



184.98



201.74



 



12.80



23.02



Rf6900



F



1.6



160.18



178.86



205.15



 



11.66



28.07



Rf6901



F



1.6



156.87



175.35



198.83



 



11.78



26.75



 



 



 



Mean



159.52



177.34



199.45



 



11.15



25.04



 



 



 



±SD



3.35



6.23



5.55



 



1.93



2.80



F: Female; SD: Standard Deviation


 


TABLE 3. INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS






























































Study Steps


&


Dose


(mg/kg body weight)



Animal No.



Sex



Fate



Gross Pathology Findings



External



Internal



Sighting Study I                              &                                 300



Rf6896



F



TS



NAD



NAD



Sighting Study II                             &                                       2000



Rf6897



F



TS



NAD



NAD



Main Study                      &                                      2000



Rf6898



F



TS



NAD



NAD



Rf6899



F



TS



NAD



NAD



Rf6900



F



TS



NAD



NAD



Rf6901



F



TS



NAD



NAD



NAD: No Abnormality Detected; F: Female; TS: Terminal Sacrifice

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the results of the experiment, it is concluded that the LD50 value for the test item Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes steam distillation condensate (EC 942-492-8) is >2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals No. 420 (Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Fixed Dose Method”. The substance is unclassified as per CLP regulation.
Executive summary:

The test item Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes steam distillation condensate (EC 942-492-8) was evaluated for acute oral toxicity in Sprague Dawley rats according to the OECD TG 420. The study was GLP compliant.
A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight because of unavailability of sufficient toxicological data on the test item.
A total of 6 females were used for the experiment. All the animals of Sighting Study I, Sighting Study II and Main Study were administered with 300 mg/kg, 2000 mg/kg and 2000 mg/kg body weight respectively of the test item through oral route.


No clinical signs of toxicity and mortalities were observed in any of the dosed animals.
No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight.
No gross pathological changes were observed in any of the dosed animals.


Based on the results of the experiment, it is concluded that the LD50 value for the test item is >2000 mg/kg body weight  via the oral route, therefore, the substance is not classified as acutely toxic according to CLP criteria (Regulation
(EC) No 1272/2008).