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EC number: 252-488-1 | CAS number: 35285-69-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Specific investigations: other studies
Administrative data
- Endpoint:
- endocrine system modulation
- Type of information:
- other: Publicataion
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Application of grouping and read-across for the evaluation of parabens of different chain lengths with a particular focus on endocrine properties
- Author:
- Susann Fayyaz, Reinhard Kreiling, Ursula G. Sauer
- Year:
- 2 021
- Bibliographic source:
- Clariant Produkte (Deutschland) GmbH, Sulzbach, Germany / Scientific Consultancy – Animal Welfare, Neubiberg, Germany
Materials and methods
Results and discussion
- Details on results:
- Fayyaz et al evaluated all available and reliable in vivo data (especially level 4 and 5 of according to OECD CF for Testing and Assessment of Endocrine Disrupting Properties (OECD 2012) to address human health concerns with respect to 90-day repeated-dose toxicity, developmental and reproductive toxicity (DART), and endocrine disrupting potential for methyl, ethyl and propyl paraben.
For methyl paraben and propyl paraben, all higher-tier studies of relevance for the determination of repeated-dose toxicity, DART and endocrine disrupting potential have been requested under REACH. For both methyl paraben and propyl paraben, the NOAEL with regard to repeated-dose toxicity and DART was set at 1000 mg/kg bw/day. For ethyl paraben, a NOAEL of 1000 mg/kg bw/day for repeated-dose toxicity and DART was estimated by interpolation from methyl paraben and propyl paraben,i.e. the two category members on both sides of the target substance (ECHA 2008; OECD 2014). Additionally, for the sodium salts of methyl paraben, ethyl paraben and propyl paraben, read-across of the NOAEL of 1000 mg/kg bw/day for repeated-dose toxicity and DART also appears justifiable on account of their very high similarities (Tc0.98) as compared to the respective paraben.
Taking all this information together no ED concern can be expected or he test item Na-propyl paraben.
Any other information on results incl. tables
Outcomes of acute toxicity, local toxicity and genotoxicity studies assessing Na-methyl paraben, Na-ethyl paraben, Na-propyl paraben
Endpoint |
Na-Methyl paraben |
Na-Ethyl paraben |
Na-Propyl paraben |
CAS Number |
5026-62-0 |
35285-68-8 |
35285-69-9 |
Acute oral toxicity studies using rats: LD50[mg/kg bw] (in brackets: OECD TG and date of study) |
|||
Acute toxicity |
> 5000 |
3100 OECD 401; 1982) |
> 5000 OECD 401; 1982) |
Local toxicity studies using rats: Classification (in brackets: OECD TG and date of study) |
|||
Skin irritation / corrosion |
Skin irritating[a] |
Not irritating |
Not irritating (OECD 404; 1982) |
Eye irritation / corrosion |
Serious eye damage |
Irritating |
Serious eye damage |
Skin sensitisation |
Not sensitising (read-across |
Not sensitising (read-across |
Not sensitising (read-across |
In vitroandin vivogenotoxicity studies: Classification (in brackets: OECD TG and date of study) |
|||
Mutagenicity |
Not mutagenic[a] (OECD 471; 2012) |
Not mutagenic |
Not mutagenic |
Mutagenicity |
Not mutagenic[a] (OECD 476; 2012) |
Not a REACH information requirement for this tonnage |
Not a REACH information requirement for this tonnage |
Genetic toxicityin vivo |
Not a REACH information requirement for this tonnage |
Higher-tier test results for methyl paraben and propyl paraben: Parameters as per Table 14 in EFSA and ECHA (2018) that allow determining if a substance is, or is not, an endocrine disruptor
Parameter |
Indicative of which modality? |
OECD TG 408 |
OECD TG 414 |
OECD TG 421 |
OECD TG 422 |
OECD TG 443 |
NOAEL for MP / NOAEL for PP |
|
Findings for methyl paraben / findings for propyl paraben |
||||||
"In vivomechanistic" parameters as per EFSA and ECHA (2018) |
|||||||
Estradiol level |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
n. r. |
Not applicable |
Follicle stimulating hormone level |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
n. r. |
Not applicable |
Luteinising hormone level |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
n. r. |
Not applicable |
Triiodothyronine / thyroxine level |
T |
NAE / NAE |
NAE / NAE (dams) |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Testosterone level |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
n. r. |
Not applicable |
Thyroid stimulating hormone level |
T |
NAE / NAE |
NAE / NAE (dams) |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
"EATS-mediated" parameters as per EFSA and ECHA (2018) |
|||||||
Accessory sex organs HP |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
n. r. |
n. r. |
1000 / 1000 |
Age at first oestrus |
E, A |
Not addressed in any OECD TG, but only in the non-internationally accepted U.S. EPA guidance OPPTS 890.1450 |
|||||
Age at balano-preputial separation |
E, A, S |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Age at vaginal opening |
E, A, S |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Anogenital distance |
E, A, S |
n. r. |
NAE / NAE |
n. a. /NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Cervix HP |
E, A, S |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Coagulating gland HP |
E, A, S |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Coagulating gland weight |
E, A, S |
n. r. |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Colloid area (thyroid HP) |
T |
n. r. |
n. r. |
n. r. |
Optional: n. e. |
NAE / NAE |
1000 / 1000 |
Cowper’s gland weight |
E, A, S |
n. r. |
n. r. |
Optional:n. e. |
Optional:n. e. |
n. r. |
Not applicable |
Epididymis HP |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Epididymis weight |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Oestrus cyclicity |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Glans penis weight |
E, A, S |
n. r. |
n. r. |
Optional:n. e. |
Optional:n. e. |
n. r. |
Not applicable |
Genital abnormalities |
E, A, S |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
HDL/LDL ratio [c] |
T |
NAE / NAE |
n. r. |
n. r. |
n. r. |
n. r. |
1000 / 1000 |
LABC muscle weight |
E, A, S |
n. r. |
n. r. |
Optional:n. e. |
Optional:n. e. |
n. r. |
Not applicable |
Liver weight [c] |
T |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Mammary gland HP; males |
E, A, S |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Mammary gland HP; females |
E, A, S |
NAE / NAE |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Nipple development |
A |
n. r. |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Ovary HP |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Ovary weight |
E, A, S |
NAE / NAE |
n. r. |
Optional:n. e. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Oviduct HP |
E, A, S |
NAE / NAE |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Prostate HP [d] |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Prostate weight |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Seminal vesicles HP |
E, A, S |
NAE / NAE |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
|
Seminal vesicles weight |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Sperm morphology |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Sperm motility |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Sperm numbers |
E, A, S |
Optional: n. e. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Testis HP |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Testis weight |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Thyroid HP |
T |
NAE / NAE |
NAE / NAE (dams) |
Optional: n. e. |
Optional:n. e. |
NAE / NAE |
1000 / 1000 |
Thyroid weight |
T |
NAE / NAE |
NAE / NAE (dams) |
Optional: n. e. |
Optional: n. e. |
NAE / NAE |
1000 / 1000 |
Uterus HP (with cervix) |
E, A, S |
NAE / NAE |
n. r. |
Optional: n. e. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Uterus weight (withcervix) |
E, A, S |
NAE / NAE |
NAE / NAE |
Optional:n. e. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Vagina HP |
E, A, S |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Vaginal smears |
E, A, S |
NAE / NAE |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
"Sensitive to but not diagnostic of EATS" as per EFSA and ECHA (2018) |
|||||||
Adrenals HP |
N |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Adrenals weight |
N |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Auditory startle |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Brain HP |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Brain morphometric evaluation [e] |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Brain weight |
N |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Dystocia |
N |
n. r. |
n. r. |
n. a. / NAE |
n. r. |
NAE / NAE |
1000 / 1000 |
Fertility |
N |
n. r. |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Foetal development [f] |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Functional observation battery [g] |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Gestation length |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Offspring: learning & memory |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Litter size |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Litter viability |
N |
n. r. |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Litter / pup weight |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Motor activity |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Motor and sensory function |
N |
This parameter is addressed in the OECD TG 426 DNT study only. The OECD TG 426 was not conducted since the findings from the EOGRTS DNT cohort provide at least comparable information. |
|||||
No. of implantations,corpora lutea |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
No. of live births |
N |
n. r. |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
No. of foetal deaths; viable foetuses |
N |
n. r. |
NAE / NAE |
n. r. |
n. r. |
n. r. |
550, highest dose [a] / 1000 |
No. of ovarian follicles |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Pituitary HP |
N |
NAE / NAE |
n. r. |
n. r. |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Pituitary weight |
N |
NAE / NAE |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Postimplantation loss |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Pre-implantation loss |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
n. r. |
1000 / 1000 |
Presence of anomalies [h] |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Pup development |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Pup survival index |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Reproduction |
N |
n. r. |
n. r. |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Sex ratio |
N |
n. r. |
NAE / NAE |
n. a. / NAE |
NAE / NAE |
NAE / NAE |
1000 / 1000 |
Time to mating |
N |
n. r. |
n. r. |
n. r. |
n. r. |
NAE / NAE |
1000 / 1000 |
Tumour types |
N |
This information can potentially to be obtained from 2-year rodent bioassays. There is no evidence for carcinogenic potential of propyl paraben, or any other paraben. |
Footnote to Table: Abbreviations: A: Androgen modality; bw: Body weight; E: Oestrogen modality; F1/F2: First / second generation offspring; HDL: High-density lipoprotein; HP: Histopathology; LABC:Levator ani bulbocavernosus; LDL: Low-density lipoprotein; MP: Methyl paraben; N: Not assignable to a given modality; n. e.: Not evaluated; n. r.: Not requested; NAE: No adverse effect; NOAEL: No-observed adverse effect level; P0: Parental animals; PP: Propyl paraben; S: Steroidogenic modality; T: Thyroid modality; TG: Test guideline.
Colour legend:Greyshading: required as per Table 14 in EFSA and ECHA (2018); “optional”: as per that Table 14 and corresponding OECD TG.
The rows of this table list all parameters listed in Table 14 of EFSA and ECHA (2018). In addition to the TGs listed in the columns, Table 14 lists the following TGs:
· OECD TG 407 (28-day repeated dose toxicity study): Not relevant for the assessment of endocrine disrupting potential of propyl paraben (or methyl paraben) since the impact of 28-day substance exposure is addressed in the (available) OECD TG 422.
· OECD TG 415 und 416 (one- and two-generation reproductive toxicity studies): Not relevant for the assessment of endocrine disrupting potential of propyl paraben (or methyl paraben) since the (available) OECD TG 443 is the preferred method for the assessment of transgenerational effects.
· OECD TG 426 (DNT study): not relevant for the assessment of endocrine disrupting potential of propyl paraben (or methyl paraben) since the (available) DNT cohort from OECD TG 443 provides comparable results.
Applicant's summary and conclusion
- Executive summary:
For substances with endocrine disrupting properties, EU legislation specifically mandates regulation via a hazard-based approach (Brescia 2020). In line with these provisions, the present research article has focused on hazard identification of methyl paraben, ethyl paraben and propyl paraben (while also considering the further category member butyl paraben and briefly referring to the sodium salts of methyl paraben, ethyl paraben and propyl paraben). For methyl paraben and propyl paraben, all higher-tier studies of relevance for the determination of repeated-dose toxicity, DART and endocrine disrupting potential have been requested under REACH, and the findings from these studies have been presented herein. For both methyl paraben and propyl paraben, the NOAEL with regard to repeated-dose toxicity and DART was set at 1000 mg/kg bw/day. For ethyl paraben, a NOAEL of 1000 mg/kg bw/day for repeated-dose toxicity and DART was estimated by interpolation from methyl paraben and propyl paraben, i.e. the two category members on both sides of the target substance (ECHA 2008; OECD 2014). The chemical category of shorter-chained linearn-alkyl parabens is founded on their high structural similarity (the only difference between these parabens is their increasing chain length) and, importantly, on their common metabolic pathway. All category members exhibit similar physico-chemical properties and similar acute toxicity, local toxicity and genotoxicity potential. A rat toxicokinetics screening studies consistently showed that due to the very rapid elimination of these parabens and their major metabolite (that is further non-toxic), systemic target organs and tissues are not exposed to these compounds for a sufficiently long period of time for effects to evolve. Due to the consistency of the findings, the interpolation of a NOAEL of 1000 mg/kg bw/day for repeated-dose toxicity and DART for ethyl paraben is assessed as acceptable with high confidence. Performing the corresponding higher-tier studies, that encompass large numbers of animals, for the hazard assessment of ethyl paraben would breach the 3Rs principle implemented in Directive 2010/63/EU (EP and Council 2010) and Article 25(1) of the REACH Regulation (EP and Council 2006) that requires that testing on vertebrate animals shall be undertaken only as a last resort.
Additionally, for the sodium salts of methyl paraben, ethyl paraben and propyl paraben, read-across of the NOAEL of 1000 mg/kg bw/day for repeated-dose toxicity and DART also appears justifiable on account of their very high similarities (Tc0.98) as compared to the respective paraben.
To the best of the authors’ knowledge, this is the first time that a comprehensive dataset from higher-tier studies conducted following internationally agreed OECD TG test protocols and in full compliance with the GLP principles has become available for linear-alkyl parabens. The data also enable a comprehensive evaluation of the endocrine disrupting potential of these parabens according to all five levels of the OECD CF for Testing and Assessment of Endocrine Disrupting Properties(OECD 2012).The higher-tier (OECD CF Level 4 and 5) studies do not provide any indication that any endocrine activity (if it were presentin vivo) would be sufficiently pronounced to overwhelm the physiological adaptive capacities of endocrine systems leading to adversity as indispensable prerequisite for endocrine disruption (WHO IPCS 2002).
As compared to the hazard-based approach pursued under the REACH Regulation for the assessment of endocrine disruptors, a risk-based approach is applied in other jurisdictions, such as USA, Canada, Australia and Japan (Brescia 2020). Risk-based approaches include exposure assessment in addition to hazard assessment to derive a conclusion on the safety of the respective substance. As highlighted by Brescia (2020), the application of a risk-based approach for the assessment of endocrine disruptors is scientifically justified since the available scientific evidence indicates that endocrine disruption exhibits a concentration threshold below which no effects will occur (Brescia 2020). Accordingly, the setting of concentration limits provides an additional safeguard to ensure consumer protection. For example, for all four shorter-chained linearn-alkyl parabens, EFSA (2004), SCCS (2013), and EMA (2015) have concluded that they are safe to the consumer when used in food, cosmetics and human medicinal products for oral use, respectively, provided that specific concentrations are not exceeded. This estimation has been re-confirmed by the findings from the present research article.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.