Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

No developmental effects were observed after exposure to the test substance after intramusular administration

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The test substance was tested for its developmental effects after intramuscular application in rabbits (Siegemund 1987). Each female animal was bred successively with 3 different males of the same breeding and origin. After visual determination of at least 2 copulations, the animals were selected for testing with the test substance. Day "0" of gestation was the day of copulations. The administration of the substance was carried out from day 6 to day 18 of gastation via percutaneous injection into the lumbar muscles. This application form was chosen to investigate the worst case (after local application complete absorption takes place). There where 3 groups of 15 animals receiving 16, 35, and 75 mg/kg bw/day as well as a control group of 12 animals. The administration volume was 0.5 mL/ kg body weight. The control group received physiological saline. At day 29 pups were born via C-Section. No influence on the general state of the females was observed. In one animal the middle dose group was in week two of gestation a complete paralysis of both hind limbs observed. This animal was euthanized at day 24 of pregnancy. A clear dose-related effect on the body weight gain was observed. Weight gain was about 13.4% (16 mg/kg) to 9.5% (75 mg/kg) in treated animals, versus 16.7% in controls. A significance was however only observed when comparing the high dose with the control group. Malformations of the fetuses were observed in both control as well as test groups. A dose response relationship was not observed for these malformations. Based on these results the NOAEL for maternal and developmental toxicity was determined to be 35 and 75.0 mg/kg bw/day, respectively.

Justification for classification or non-classification

Based on the results obtained from the available data, classification for developmental toxicity is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.