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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via dermal route
Endpoint conclusion:
no study available (further information necessary)
Additional information

In a reproductive/developmental toxicity screening study following OECD testing guideline 421 and GLP, 10 Sprague-Dawley rats/sex/group were exposed to Gum Rosin at dose concentrations of 0, 1000, 3000, or 10000 ppm for 41-45 days (females) or 30 days (males) in the diet. Treatment with Gum Rosin at 10000 ppm was associated with reduced weight gain/weight loss and reduced food consumption in the parental generation and a slight decrease in the mean number of implantation sites resulting in a subsequent slight reduction in litter size. Body weight gain reductions were also observed in males exposed to 3000 ppm Gum Rosin. Adverse effects in the F1 pups were limited to slightly reduced litter and pup weights. Based on the results of the present study, the no-observed-effect-level (NOEL) for reproductive/developmental toxicity in Sprague-Dawley rats was considered to be 3000 ppm for males and females and the NOEL for subchronic toxicity was considered to be 1000 ppm in males and 3000 ppm in females based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.  

A pre-natal developmental toxicity test (OECD 414) on rosin has been proposed by the lead registrant for rosin to complement this information.

Information regarding read-across is attached at the end of the Chemical Safety report.


Short description of key information:
A screening study (OECD 421) is available for rosin and the NOEL is 3000 ppm (Inveresk 2002).

Effects on developmental toxicity

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 (further information necessary)
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available (further information necessary)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available screening study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for fertility or developmental toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG. 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).

During the four days covered in the screening study, no effects via lactation were observed.

Additional information