Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Rats (10/sex/dose) were exposed to 0, 50, 150 and 1000 mg/kg bw/day AD-1000, males for 28-days (from 2 weeks prior to mating onwards) and females for 40 -48 days (from 2 weeks prior to mating onwards up to at least 3 days of lactation). OECD test guideline 421 and OPPTS 870.3550 were followed. Accuracy, homogeneity and stability of formulations were demonstrated by analyses. There were no treatment-related changes for mortality, clinical signs, body weight, food consumption, macroscopic and microscopic examinations and organ weights up to and including 1000 mg/kg bw/day. No treatment-related changes for reproduction, breeding data and pup development were noted up to 1000 mg/kg bw/day. At the highest dose, increased postnatal loss and reduced viability index was noted. However, as this effect was driven exclusively by one litter that lost all but one pup it is considered not to reflect treatment-related toxicity. Therefore, the parental, reproduction, fertility and developmental NOAEL was derived to be at least 1000 mg/kg bw/day.


Short description of key information:
In a study with rats performed according to OECD guideline 421, no effects were observed at the highest dose tested, i.e. 1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information
In a study with rats performed according to OECD guideline 421, no effects were observed at the highest dose tested, i.e. 1000 mg/kg bw/day.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Rats (10/sex/dose) were exposed to 0, 50, 150 and 1000 mg/kg bw/day AD-1000, males for 28-days (from 2 weeks prior to mating onwards) and females for 40 -48 days (from 2 weeks prior to mating onwards up to at least 3 days of lactation). OECD test guideline 421 and OPPTS 870.3550 were followed. Accuracy, homogeneity and stability of formulations were demonstrated by analyses. There were no treatment-related changes for mortality, clinical signs, body weight, food consumption, macroscopic and microscopic examinations and organ weights up to and including 1000 mg/kg bw/day. No treatment-related changes for reproduction, breeding data and pup development up to 1000 mg/kg bw/day. At the highest dose, increased postnatal loss and reduced viability index was noted. however, as this effect was driven exclusively by one litter that lost all but one pup it is considered not to reflect treatment-related toxicity. Therefore, the parental, reproduction, fertility and developmental NOAEL was derived to be at least 1000 mg/kg bw/day

Justification for classification or non-classification

Based on the studies available, AD-1000 does not need to be classified according to 67/548/EEC and the CLP Regulation (EC) No 1272/2008 for reproduction and/or developmental toxicity.

Additional information