Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012/2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Version / remarks:
adopted March 1996
Qualifier:
according to
Guideline:
other: EPA OPPTS 870.3650, adopted July 2000
GLP compliance:
yes (incl. certificate)
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH (male and female animals were derived from different litters to rule out mating of siblings)
- Age at study initiation: 10-11 wks
- Weight at study initiation: on average: Males: 335g; Females: 197g
- Fasting period before study: no
- Housing: single (except during mating and during lactation) in Markrolon type M III cages
- Diet (e.g. ad libitum): ground Kliba maintenance diet mouse-rat “GLP”, meal ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: app. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The desired amount of test substance was weighed, and corn oil was added up to the correct volume. To prepare a homogenous suspension, the mixture was stirred with a magnetic stirrer also during administration. The test substance preparations were produced at least once a week and were stored at room temperature. The administration volume was 4 mL/kg body weight.

VEHICLE
- Justification for use and choice of vehicle (if other than water): The test substance is poorly soluble in water, but forms a homogenous suspension in corn oil, which is also non-toxic to rats.
- Concentration in vehicle: 1.25; 3.75; 12.5g/100mL
Details on mating procedure:
- M/F ratio per cage: 1:1 over night
- Length of cohabitation: until sperm was detected in vaginal smear or for a maximum of 14 days
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged (how): individually
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Homogeneity and concentration control analyses of the test-substance preparations were performed in all concentrations at the start of the administration period. Additionally, samples from all concentrations as reverse samples for concentration control analysis were taken at the end of the study. The concentration control analyses of all concentrations revealed that the values were in the expected range of the target concentrations, i.e. were always in a range of about 90.0-110.0% of the nominal concentrations. Considering the low relative standard deviation in the homogeneity analysis, it can be concluded that Laromer PO 33 F was distributed homogeneously in corn oil.
Duration of treatment / exposure:
Males: 35 days
Females: 56 days
Frequency of treatment:
daily (except to animals being in labor)
Remarks:
Doses / Concentrations:
50, 150, 500 mg/kg b.w.
Basis:
actual ingested
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: The selection of doses was based on the results of a test study in female Wistar rats (BASF project No. 10C0457/11S163) conducted at dose levels of 0, 600 and 1000 mg/kg bw/d. In this study, a NOAEL was not established due to erosions and ulcerations in the stomach of different animals at both dose levels of 600 and 1000 mg/kg bw/d as well as clinical findings like poor general condition, piloerection and body weight loss after 1 week of treatment.
Positive control:
no
Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily on workdays, daily on weekends and public holidays
- Cage side observations: check for moribund animals, pertinent behavioral changes, signs of overt toxicity, parturation, littering and lactation behavior of the dams

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: prior to the first administration, weekly thereafter
- The following parameters were examined: abnormal behavior during “handling”, fur, skin, posture, salivation, respiration, activity/arousal level, tremors, convulsions, abnormal movements, impairment of gait, lacrimation, palpebral closure, exophthalmus, feces (appearance/consistency), urine, pupil size

BODY WEIGHT: Yes
- Time schedule for examinations: day 0, weekly thereafter with the following exceptions for females: During the mating period the parental females were weighed on the day of positive evidence of sperm (GD 0) and on GD 7, 14 and 20. Females with litter were weighed on the day of parturition (PND 0) and on PND 4.

FOOD CONSUMPTION:
- Food consumption for each animal determined: Yes, except during mating

WATER CONSUMPTION: Monitored by daily visual inspection

OTHER (for details see entry for this study in the repeated dose section):
- Functional observation battery and motor activity measurement of 5 males and females per group 2 days prior to sacrifice
- Urinanalysis in 5 males and females per group one day prior to necropsy
- Clinicochemical and hematological examinations 5 males and females on the day of necropsy after fasting for 16h
Sperm parameters (parental animals):
Parameters examined in male parental animals:
testis weight, epididymis weight, stages of spermatogenesis in the male gonads
Litter observations:
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, clinical symptoms, weight gain

GROSS EXAMINATION OF DEAD PUPS:
yes, externally and organs were assessed macroscopically
Postmortem examinations (parental animals):
SACRIFICE
- Male animals: All surviving animals on day 36
- Maternal animals: All surviving animals on day 57

GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations

HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were weighed
- in all animals: epididymides, testes
- in 5 males and females of each group: adrenal glands, brain, heart, kidneys, liver, spleen, thymus
The uteri of all cohabited female parental animals were examined for the presence and number of implantation sites. The uteri of apparently non-pregnant animals or empty uterus horns were placed in 1% ammonium sulfide solutions for about 5 minutes in order to be able to identify early resorptions or implantations.
The following tissues were examined histotechnically in at least 5 animals per sex of the control and high dose group (reproductive organs were examined in all high dose and control animals):
adrenal glands, gross lesions (all affected animals in all dosage groups), bone marrow (femur), brain, cecum, cervix, coagulation glands, colon, duodenum, epididymides, heart, ileum, jejunum, kidneys, liver, lungs, lymph nodes (auxillary and mesenteric), ovaries, oviducts, prostate gland, peyer's patches, rectum, sciatic nerve, seminal vesicles, spinal cord, spleen, stomach, testes, thymus, thyroid glands, trachea, urinary bladder, uterus, vagina
Postmortem examinations (offspring):
NECROPSY
- All surviving pubs were subjected to postmortem examinations: external examination and macroscopic examination of organs. Animals with notabel findings or abnormalitites were evaluated on a case-by-case basis.
Reproductive indices:
For the males, mating and fertility indices were calculated for F1 litters according to the following formulas:
Male mating index (%) = number of males with confirmed mating (vaginal sperm detected in females) / number of males placed with females x100
Male fertility index (%) = number of males proving their fertility (implants in utero) / number of males placed with females x100

For the females, mating, fertility and gestation indices were calculated for F1 litters according to the following formulas:
Female mating index (%) = number of females mated (vaginal sperm detected) / number of females placed with males x100
Female fertility index (%) = number of females pregnant (implants in utero) / number of females mated (vaginal sperm or implants in utero) x100
Gestation index (%) = number of females with live pups on the day of birth / number of females pregnant x100
Offspring viability indices:
Live birth index (%) = number of liveborn pups at birth / total number of pups born x100
Viability index (%) = number of live pups on day 4 after birth / number of live pups on the day of birth x100
CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS)
Female animal No. 131 of test group 3 (500 mg/kg bw/d) was sacrificed in a moribund condition on study day 51 (GD 24). Vaginal discharge was observed on GDs 23-24 in this animal, which showed poor general state and was unable to deliver on GD 24. This animal was sacrificed moribund on the same day. According to the pathological results the findings were assessed as being incidental and not related to treatment.

Almost all male and most female animals of the high dose group showed salivation within 2 hours after the administration on several days of the study. Salivation within 2 hours after treatment was also seen in several mid dose male and female animals. From the temporary, short appearance immediately after dosing it was concluded that salivation was induced by a bad taste of the test substance or local affection of the upper digestive tract.

BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No test substance-related changes in body weight or body weight gain were observed for all test groups.

REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
For all male and female animals mating was confirmed (mating index of 100%). Male and female fertility index varied between 80% and 90%. All pregnant rats in all dose groups delivered pubs with the exception of 1 high dose female which was sacrificed moribund on GD24.
High dose female animal No. 135, that was not pregnant, revealed a decrease in ovary size and a diffuse atrophy of both ovaries and no corpora lutea. This was regarded to be the cause of the infertility in this pair. All other females and their male mating partners did not show gross lesions in reproduction relevant organs which could explain the lack of offspring.

ORGAN WEIGHTS (PARENTAL ANIMALS)
All mean weight parameters (absolute and relative) did not show significant differences when compared to the control groups.

GROSS PATHOLOGY (PARENTAL ANIMALS)
All gross lesions noted were single observations and they were regarded to have developed spontaneously and unrelated to compound and treatment.

HISTOPATHOLOGY (PARENTAL ANIMALS)
All findings were considered to be incidental or spontaneous in origin and without any relation to treatment.
The high dose female animal No. 131 that was sacrificed in a moribund state revealed a decidual reaction with consequent inflammation of the uterus. Decidual reaction is a proliferation of decidual cells (tissue of endometrial origin lining of the uterus, which is in contact with the fetal membranes and the placental plate). They often are assiocated with inflammation as observed in this animal. The local inflammation in the uterus can lead to disturbance of the general condition or, if the inflammation is spreading, sepsis. This was regarded to be the reason for the moribund state of this animal but was not regarded to be treatment-related.
Dose descriptor:
NOAEL
Remarks:
systemic toxicity
Effect level:
>= 500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Dose descriptor:
NOAEL
Remarks:
fertility and reproductive performance
Effect level:
>= 500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
VIABILITY (OFFSPRING)
Single stillborn pubs were seen in the low dose and mid dose group only. The mean number of delivered pups per dam and the rate of liveborn and stillborn pups reflect the normal range of biological variation inherent in the strain used in this study.
The viability index as indicator for pup mortality between PND 0 and 4 was 89% in the low dose group (all pups of female No. 113 died), 99% in the mid dose group (1 pup of female No. 124 died) and 100% for high dose and control females. As the decreased viability index in the low dose group was still within the historical control data, statistically not significant, and related to mentioned litter loss of only one female animal, the finding was assessed to be incidental and not related to treatment.
The sex distribution and sex ratios of live F1 pups on the day of birth and on PND 4 did not show biologically relevant differences between test groups.

CLINICAL SIGNS (OFFSPRING)
Ten of 14 pups in the litter of low dose female animal No. 113 showed reduced nutritional condition on PND 0. All pups in this litter died between PND 0-1. Each one pup of mid dose female animals Nos. 122 and 124 died on PND 0. These findings were assessed as being incidental as no dose-reponse relationship occurred. The surviving F1 pups of any test group did not show adverse clinical signs up to scheduled sacrifice on PND 4.

BODY WEIGHT (OFFSPRING)
Mean pup body weights/pup body weight changes of all pups in all test groups were comparable to the concurrent control values.

GROSS PATHOLOGY (OFFSPRING)
No test substance-related changes were observed.
Dose descriptor:
NOAEL
Remarks:
developmental toxicity
Generation:
F1
Effect level:
>= 500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Additional information

Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate was administered orally by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 mg/kg body weight/day, 50mg/kg bw/d, 150mg/kg bw/d, and 500mg/kg bw/d in corn oil. The doses were selected based on a 14day test study in female Wistar rats, conducted at dose levels of 600 and 1000mg/kg. In this study, a NOAEL was not established due to erosions and ulcerations in the stomach of different animals at both dose levels of 600 and 1000 mg/kg bw/d as well as clinical findings like poor general condition, piloerection and body weight loss after 1 week of treatment.

The duration of treatment in the main study covered 35days for males and 56 days for females. After 2 weeks of premating treatment the F0 animals were mated in a 1:1 ratio to produce F1 generation pups. Mating pairs were from the same test group. Mating was discontinued as soon as sperm was detected in the vaginal smear. A detailed clinical observation was performed in all animals before initial test substance administration and at weekly intervals thereafter. Food consumption and body weight of the animals were determined in app. weekly intervals. The pups were sexed and examined for macroscopically evident changes on PND 0. They were weighed on PND 1 and on PND 4. Their viability was recorded. At necropsy on PND 4, all pups were sacrificed under isoflurane anesthesia with CO2 and examined macroscopically for external and visceral findings. Towards the end of the administration period, a functional observational battery was performed and motor activity was measured in 5 animals per sex and test group. Clinicochemical and hematological examinations as well as urinalyses were also performed towards the end of the administration period in 5 animals per sex and test group. All animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed.

No signs of systemic toxicity were observed up to the highest dose level of 500mg/kg bw/d in animals of both sexes, and no difference regarding clinical parameters or histpathology were observed. Especially no effect on reproductive organs could be detected. Fertility indices for male and female animals were not impaired by test-substance administration even at a dose level of 500 mg/kg bw/d. In addition, live birth indices and viability of pups in all test groups were not altered. Thus, the no observed adverse effect levels (NOAEL) for general systemic toxicity, fertility, and developmental toxicity was set to 500mg/kg bw/d in male and female animals.


Short description of key information:
Combined repeated dose / reproductive toxicity testing, rat, gavage: NOAEL >=500mg/kg (OECD 422, GLP, BASF 2013)

Effects on developmental toxicity

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study equivalent to OECD guidelines
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
GLP compliance:
yes
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
other: Sprague Dawley COBS CD rats
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding laboratories, Inc., Portage, Michigan
- Age at study initiation: 13 wk
- Weight at study initiation: 225-297 g
- Housing: Individually housed in wire mesh cages suspended above cage board
- Diet: Purina certified rodent chow; ad libitum
- Water: Tap water; ad libitum
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 0.16 °C
- Humidity (%): 40 %
- Photoperiod (h dark / h light): 12 h dark / 12 h light
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Dosing solution was prepared with corn oil using magnetic stir plate and bars


VEHICLE: CORN OIL
- Lot/batch no. (if required): May 14 85
- Purity: 100 %
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Details on mating procedure:
- Impregnation procedure: Cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Verification of same strain and source of both sexes: Yes
- Proof of pregnancy: Presence of vaginal plug referred to as Day 0 of pregnancy
Duration of treatment / exposure:
10 d, from Day 6 to 15 of gestation, inclusive
Frequency of treatment:
Once daily
Duration of test:
25 d
Remarks:
Doses / Concentrations:
0 and 1,000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
30 females/dose
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: Based on the results of a range-finding study, the test dosage (1,000 mg/kg/d) was selected since it was anticipated to induce some degree of maternal toxicity but one which would not likely affect maternal survival.
- Rationale for animal assignment: Random
Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily


DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: From Day 0 through 20 of gestation


BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 6, 9, 12, 16 and 20
- Mean body weight changes were calculated for each corresponding interval of gestation additionally for Day 6-16, 16-20
and 0-20


POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day 20



Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
Fetal examinations:
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: all per litter
Statistics:
1. The fetal sex ratios were compared by the Chi-square test with Yates' correction factor.
2. The number of litters with malformations and developmental variations were compared by Fisher's Exact Test
3. The numbers of early and late resorptions, dead fetuses and postimplantation losses were compared by the Mann-Whitney U-test
4. Mean numbers of corpora lutea, total implantations, viable fetuses, mean fetal and maternal body weights, and maternal body weight gain at each interval were analyzed by a one-way ANOVA and Dunnett's test
Indices:
- Fetal sex ratios, number of litters with malformations and developmental variations, numbers of early and late resorptions, dead fetuses and postimplantation losses
- Numbers of corpora lutea, total implantations and viable fetuses
Historical control data:
Yes, WlL historical control data appended in the report
Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
- Two rats died due to an intubation error
- Slight decrease in mean body weight gain was observed during gestation Day 12-16
- Significant decrease in mean body weight gain was noticed during gestation Day 6-16
- Clinical signs of toxicity such as salivation prior to and following dosing; urogenital matting and hair loss from various body surfaces were observed
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No substance related effects observed
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Basis for effect level:
other: embryotoxicity
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Basis for effect level:
other: teratogenicity
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
The test substance produced substantial maternal toxicity at a dose level of 1,000 mg/kg bw/day but did not induce a teratogenic or embryotoxic effect in rats.
Executive summary:

The study was conducted equivalent or similar to OECD Guideline No. 414 in compliance with Good Laboratory Practices. The test substance was administered orally, admixed in corn oil, to one group of 30 bred rats at a dosage level of 1,000 mg/kg bw/day, from gestation Day 6 through 15. A control group consisting of 30 rats received the corn oil vehicle on a comparable regimen. Throughout gestation, all rats were observed twice daily for signs of toxicity. Body weights were recorded at appropriate intervals. All surviving animals were sacrificed on gestation Day 20 for the scheduled Cesarean section. Fetuses were sexed, weighed and examined for external, skeletal and soft tissue anomalies and developmental variations.

Clinical signs of toxicity such as salivation prior to and following dosing, urogenital matting and hair loss from various body surfaces were observed. Mean body weight gains were significantly reduced over the entire treatment period. No embryotoxic effects were apparent. Developmental variations were not remarkably different between the control and test material group. No statistically significant or biologically meaningful differences occurred between the control and treatment regarding the occurrence of malformations.  

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Aside from the limited results on developmental toxicity that were obtained from the combined repeated dose/developmental toxicity screening assay, no further information exist for Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate. However, valid data exist for the structurally similar substance Propylidynetrimethanol, ethoxylated, esters with acrylic acid (CAS28961 -43 -5).

This substance was administered orally, admixed in corn oil, to one group of 30 female Spraque Dawley rats at a dosage level of 1,000 mg/kg bw/day, from gestation Day 6 through 15. 30 control animals received the 10mL/kg corn oil on a comparable regimen. Throughout gestation, all rats were observed twice daily for signs of toxicity. Body weights were recorded at appropriate intervals. All surviving animals were sacrificed on gestation Day 20 for the scheduled Cesarean section. Fetuses were sexed, weighed and examined for external, skeletal and soft tissue anomalies and developmental variations. Clinical signs of toxicity such as salivation prior to and following dosing, urogenital matting and hair loss from various body surfaces were observed. Mean body weight gains were significantly reduced over the entire treatment period. No embryotoxic effects were apparent. Developmental variations were not remarkably different between the control and test material group. No statistically significant or biologically meaningful differences occurred between the control and treatment regarding the occurrence of malformations. In conclusion, TMPeoTA produced substantial maternal toxicity at a dose level of 1,000 mg/kg bw/day but did not induce a teratogenic or embryotoxic effect in rats.

Read across justification

Propylidynetrimethanol, ethoxylated, esters with acrylic acid (CAS28961 -43 -5) is structurally similar to Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate (CAS118800 -30 -9). Both molecules show no acute toxicity after oral or dermal exposure and did not induce gene mutations in bacteria or mammalian cells. In the developmental toxicity study using the read across substance Propylidynetrimethanol, ethoxylated, esters with acrylic acid at 1000mg/kg b.w., poor general state and weight loss were observed in maternal animals, presumably as the result of local irritation of the gastrointestinal tract. Erosions in the stomach accompanied by weight loss within one week were also observed in the range finding test conducted with Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate using 600 and 1000mg/kg b.w.

The missing propoxy elements in CAS28961 -43 -5 shorten the chain between the propylidynetrimethanol and the acrylic acid groups, leading to a lower molecular weight of app. 433g/mol and lower logPow of 2.89. It is reasonable to assume, that this also leads to a higher reactivity (i.e., an eye irritating and skin sensitizing potential, which is not observed for CAS118800 -30 -9), since the not ethoxylated Trimethylolpropane triacrylate (moleculare weight 296mg/mol, logPow 0.67) shows a further increased sensitizing potential in addition to eye and skin irritation, while also not being acutely toxic or mutagenic. Thus using data from 28961 -43 -5 is a reasonable worst case approach to cover the endpoints required for Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate.

Justification for classification or non-classification

Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate did not impair fertility not lead to developmental defects as determined in an OECD 422 screening study. A developmental toxicity study using the read across substance Propylidynetrimethanol, ethoxylated, esters with acrylic acid also did not show any developmental toxicity, though significant maternal toxicity occured.

Thus, classification of Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate according to 67/548/EEC or CLP/EU-GHS is not warranted.