Registration Dossier

Administrative data

Description of key information

An oral study according to OECD 422 was done on the Source Substance 2, docosanoic acid. The NOAEL of the study was 1000 mg/kg bw/d.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Remarks:
combined repeated dose and reproduction / developmental screening
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
On the basis of all evaluated data, the similarity of all category members of the ISOCARB is justified on basis of the physico-chemical properties, toxicological and ecotoxicological profiles. There is convincing evidence that these chemicals possess an overall common category profile. ISOCARB are aliphatic branched carboxylic acids and include substances with carbon chain lengths of C11 to C24. Their only functional group is the carboxyl group, which they share in common. All ISOCARB have a single branching at the C2 position, where the branches differ in chain length from methyl to decyl.
Reason / purpose:
other: Category Approach
Strain:
Sprague-Dawley
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
significant increase was observed in 100 mg/kg bw/day group (non-adverse)
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
significant decrease was observed in 100 mg/kg bw/day group during lactation (non-adverse)
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
significant decrease of mean corpuscular haemoglobin concentration in the 300 and 1000 mg/kg bw/day groups (non-adverse)
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
non-adverse
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
non-adverse
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
non-adverse
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
non-adverse
Histopathological findings: neoplastic:
no effects observed
Key result
Dose descriptor:
NOAEL
Remarks:
repeated dose toxicity
Effect level:
>= 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse substance-related systemic effects were noted
Key result
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimish 2

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

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the test results the Category member 2 -decyltetradecanoic acid does not need to be classified according to

Regulation (EC) No 1272/2008.