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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
23 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed

Effects on developmental toxicity

Description of key information

DIXD is the hydrolysis product of AS100. AS100 studies have been used as read-across for developmental toxicity behavour. The developmental toxicity study was performed to assess the effects of the test item AS100 on the embryonic and foetal development (including the organogenesis period) of Hannover Wistar rats in their first pregnancy.

At both mid and high dose groups maternal toxicity was observed in bodyweight loss and increased liver and spleen weights, however, there was no evidence of adverse treatment effects seen at external, visceral or skeletal foetal examination at all dose groups.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
210 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study has been conducted according to OECD Guideline 414 and GLP and is adequately reported. The study has been assigned a reliability 1.
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

Litter Responses:

Offspring Litter Size, Sex Ratio and Viability.

In the Prenatal study, Mean foetal body weights were unaffected by maternal treatment with AS100 at any dose level. Although the overall mean foetal body weights, and the mean weight of foetuses evaluated by litter mean, were statistically significantly higher at the low and mid dose levels (by 5.5 and 6.1%, respectively ) all values were in the normal historical range and there was no clear dose response relationship. Therefore these statistical differences were considered not related to treatment.

The mean number of viable foetuses was comparable with the control mean. The sex distribution of foetuses did not differ significantly between the control and treatment groups both for mean and absolute numbers.

Offspring Observations.

No clinically observable signs of toxicity were detected for offspring from any treatment groups.


Justification for selection of Effect on developmental toxicity: via oral route:
The OECD 414 prenatal developmental toxicity study is assigned as reliability study 1 and complements the screening study for fertility and development toxicity study available, OECD 421. The NOAEL for embyrotoxic, foetotoxic and teratogenic effects is over 210mg/kg/day (the high dose group)

Justification for classification or non-classification

Advsere effects on development of the offspring

OECD 414 provides data to support non classification. The NOAEL for embyrotoxic, fetotoxic and teratogenic effects was above the highest dose group of 210mg/kg/day though maternal toxicity was observed at LOAEL 70mg/kg/day

Additional information