Study ID
Reference (title, number, year)	Rosin, glycerol ester CAS 8050‐31‐5: Oral (Dietary) Pre‐Natal Developmental Toxicity Study in the Rat, Study number 41403694, 2016 (Documentation provided to EFSA No 6)
Source (published/unpublished)	Unpublished
Overview of the study and guideline
Good Laboratory Practice (yes/no)	Yes
Guideline studies (if yes, specify)	OECD 414, adopted 22 January 2001
Animal model
Species and strain	Sprague–Dawley Crl:CD® (SD) IGS BR strain rats
Disease models (e.g. diabetes, allergy, obesity)	No
Housing conditions
Housing condition	Individually
Diet name and source (if reported)	Rodent PMI 5002 Ground diet and tap water ad libitum
Treatment
Test material	Rosin, glycerol ester CAS 8050‐31‐5
Provider
Compound purity	100%
Vehicle used	–
Dose regimen (dose level or concentration per group, and frequency) and achieved doses if available	0, 3,000, 7,500 or 15,000 mg/kg diet, equal to 0, 241, 608 or 1,228 mg/kg bw per day, respectively
Route of administration (diet, drinking water, gavage)	Diet
Period of exposure (pre‐mating, mating, gestation, lactation, adult)	Between gestation days 3 and 19 (inclusive)
Duration of the exposure	17 days
Study design
Sex and age at the start of the treatment	Female, adult, time‐mated
Number animals/sex/group	24/female/group, 4 groups
Measured endpoints	According to the guideline
Time of measurement/observation period	According to the guideline
Methods to measure the endpoints	According to the guideline
Statistical analysis
Statistical methods	Shapiro–Wilk normality test and Bartlett's test for homogeneity of variance and one way analysis of variance, followed by Dunnett's multiple comparison test or if unequal variances were observed. Kruskal–Wallis non‐parametric analysis of variance; and a subsequent pairwise analysis of control values against treated values using the Mann–Whitney ‘U' test, where significance was seen.
Results
Findings reported by the study author/s	No treatment‐related findings. Absent renal papilla was noted in one fetus in the intermediate dose and in two foetuses (from different litters) in the high‐dose group. These findings are reported to be within the range of historical controls.
No observed adverse effect level, lowest observed adverse effect level, benchmark dose/benchmark dose lower bound	The no observed adverse effect level’ (NOAEL) for the pregnant female and for prenatal developmental toxicity was considered to be 15,000 mg/kg diet equal to 1,228 mg/kg bw per day.
Further information
Panel assessment: The Panel considered that the test substance did not adversely affect pregnancy or in utero development up to an oral dose of 1,228 mg/kg bw per day.

bw: body weight; CAS: Chemical Abstracts Service.