Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Screening study:

In accordance with Column 2 of REACH Annex VIII section 8.7.1, a screening for reproductive/developmental toxicity study does not need to be conducted, if a pre-natal developmental toxicity study (Annex IX, Section 8.7.2) is available.

Two generation study:

Wegener H (1953) examined the effects of glycerol on fertility, by oral administration (gavage, in drinking water) of the test substance to groups of male and female rats through two generations, until 100 days of age. The highest dose tested was 2000 mg/kg/day, and the rats were exposed during 8-12 weeks (starting before mating and continuing, in females, until weaning). There was no effect noted on growth, fertility and reproductive performance through two generations at 2000 mg/kg/day.


Short description of key information:
The toxicity to reproduction of glycerine carbonate was studied with the read-across substance glycerol.
In a K2 study, glycerol was administered by oral gavage to groups of male and female rats through two generations. There was no effect noted on growth, fertility and reproductive performance through two generations at 2000 mg/kg/day.

Justification for selection of Effect on fertility via oral route:
Only one reliable study was identified with the read-across substance glycerol. The study has been identified as K2 study as it was performed with a 'read across' substance. The read across justification is added in section 13 of IUCLID.

Effects on developmental toxicity

Description of key information
The developmental toxicity  of glycerine carbonate was studied with the read-across substance glycerol.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 180 mg/kg bw/day
Study duration:
subchronic
Species:
rabbit
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

A read-acrossdevelopmental toxicity studywith glycerol in rats, mice and rabbits was performed in the spirit of OECD Guideline 414. The animals were administered orally the test substance (glycerol) at day 6-18 of gestation inclusive, at the following concentrations:

-       Rats (Wistar):13.1, 60.8, 282 and 1310 mg/kg bw (dosing volume <6 mL/kg) (actual ingested)

-       Rabbits (Dutch):11.8, 54.8, 254.5 and 1180 mg/kg bw (dosing volume <6 mL/kg) (actual ingested)

-       Mice (CD-1): 12.8, 59.4, 276 and 1280 mg/kg bw (actual ingested)

The following results were obtained:

Rats: NOAEL (maternal toxicity and developmental toxicity ): 1310 mg/kg bw/day (actual dose received) based on: test mat. (No effects were observed in animals dosed with glycerol)

Rabbits: NOAEL (maternal toxicity and developmental toxicity ): 1180 mg/kg bw/day (actual dose received) based on: test mat. (No effects were observed in animals dosed with glycerol)

Mouse: NOAEL (maternal toxicity and developmental toxicity ): 1280 mg/kg bw/day (actual dose received) based on: test mat. (No effects were observed in animals dosed with glycerol).

For the read-across, only the study with the lowest NOAEL value was added to the glycerine carbonate dossier: 1180 mg/kg bw/day.


Justification for selection of Effect on developmental toxicity: via oral route:
Only one reliable study was identified with the read-across substance glycerol The study has been identified as K2 study as it was performed with a 'read-across' substance. The read across justification is added in section 13 of IUCLID.

Justification for classification or non-classification

Based on the read-across data of glycerol and the criteria of the DSD and CLP Regulation, the substance should not be classified as reproductive toxicant.

Additional information