Registration Dossier

Administrative data

Description of key information

The test substance, Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide, was tested for subchronic toxicity using the Method B.26 Sub-Chronic Oral Toxicity Test: Repeated Dose 90-day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008. 
No other studies on repeated dose toxicity (dermal or inhalation) of the substance are available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
160 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The repeated dose oral toxicity 90-day study in Wistar rats of SPF quality was performed.

The test substance was administered in olive oil by stomach tube, oral application of rats was made daily. Four main groups and two satellite groups of animals were used. Main groups contained 3 treated groups (doses 160, 400, 1000 mg/kg of body weight /day) and one control group (vehicle only). The satellite groups contained one control group (vehicle only) and one treated group (1000 mg/kg/day).

 

The value of NOAEL (No Observed Adverse Effect Level) was established 160 mg/kg/day. The value was established mainly on the basis of changes in red blood cell component, biochemical parameters related to kidney function and histopathology of the liver.

 


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; urogenital: kidneys

Justification for classification or non-classification

According to the Regulation (EC) No.1272/2008 the data from the study „Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide - Repeated Dose 90-day Oral Toxicity Study“ (Study No. 49/10/8, VUOS Report No.11-46, 2011) are of acceptable quality for classification or non-classification of substances for STOT RE (Specific Target Organ Toxicity – Repeated Exposure).

The determined value of NOAEL (160 mg/kg body weight/day) was used for comparison with classification criteria.

In accordance with guidance values for STOT RE (Guidance to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures) the value (dose/concentration) for STOT RE Category 1 is C ≤ 10 mg/kg body weight/day, the range (dose/concentration) for STOT RE Category 2 is 10 < C ≤ 100 mg/kg body weight/day for oral route exposure.

The value of NOAEL (160 mg/kg body weight/day) is above the guidance values and range (C).

Based on results of Repeated Dose 90-day Oral Toxicity Study, the substance „Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide“ is not classified as specific target organ toxicant - repeated exposure.