Registration Dossier

Administrative data

Description of key information

A No- Observable-Adverse-Effect Level (NOAEL) of 300 mg/kg body weight per day is defined for males and 1000 mg/kg body weight per day for females

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
300 mg/kg bw/day

Additional information

Oral administration of CA 2342 A to rats by daily gavage was well tolerated at all dose levels tested. In the absence of histopathologic correlates as well as supportive findings from organ weight analysis, the changes seen on some blood chemistry parameters (at dose levels of 100 mg/kg bw per day and above) point to influencing the renal function. In addition, adaptive changes of the liver were observed. Reversibility was demonstrated for all changes within a 4-week treatment free period except for calcium concentration in blood of males. Due to the irreversibility in males, a No- Observable-Adverse-Effect Level (NOAEL) of 300 mg/kg body weight per day is defined for males and 1000 mg/kg body weight per day for females.


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

Justification for classification or non-classification

For a classification as Category 2 STOT-RTD (specific target organ toxicity, repeated dose toxicity), both UN-GHS and EU-GHS (CLP) are using as guidance values for the 28 days oral chronic toxicity test a cut-off value of 300 mg/kg bw (daily gavage) as observed effect level. Since the single observed irreversible health effect, the calcium blood level in males, occured at a higher dose only, GHS classification does not apply for chronic oral toxicity of CA 2342 A. This is also supported by section 3.9.2.8 in the GHS and CLP documents, where it is stated that small changes in blood chemistry would not justify classification.