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EC number: 202-597-5 | CAS number: 97-63-2
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across from analogous category member
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see attached category document
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
see attached category document, chapter 1.1
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached category document, chapter 1
3. ANALOGUE APPROACH JUSTIFICATION
see attached category document, chapter 5 (Toxikokinetics) and endpoint specific chapters
4. DATA MATRIX
see attached category document, endpoint specific chapters
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Reference Type:
- other:
- Title:
- Initial submission: Letter from Methacrylates Producers Association Incorporation to USEPA RE summaries of methacrylate toxicity|studies conducted in Japan, with attachments and dated 8/2/1999, Ministry Hlth, OTS0559766
- Author:
- MPA (Methacrylate Producers Association)
- Year:
- 1 999
- Bibliographic source:
- Methacrylates Producers Associationents and dated|8/2/1999, Ministry Hlth, OTS0559766
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Butyl methacrylate
- EC Number:
- 202-615-1
- EC Name:
- Butyl methacrylate
- Cas Number:
- 97-88-1
- Molecular formula:
- C8H14O2
- IUPAC Name:
- butyl methacrylate
- Details on test material:
- Mitsubishi Gas Chem. Co., Inc., Lot No. NG60912, Purity: 99.6 %, kept cool and dark until use
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 1) Age at study initiation: 9 weeks old for males and 8 weeks old for females
2) Weight at study initiation: 340-373 g for males, 198-222 g for females
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Duration of treatment / exposure:
- Exposure period: Males; for 44 days
Females; from 14 days before mating to Day 3 of lactation - Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0(vehicle), 30, 100, 300, 1000 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
2) Number of corpora lutea, implantation sites and implantation index In the 1000 mg/kg group, significant decreases in the number of corpora lutea and implantation sites were observed. There was no significant change in the implantation index. See table below
(3) Delivery index and gestation period The delivery index was 100% in the control group and all the treated groups.
There was no significant change in the gestation period.
(4) Parturition and lactation For the condition of parturition, no abnormality was observed in any parent animals in any group. For lactation, one animal in the 30 mg/kg group showed no lactating behavior on Day 0 of lactation and cannibalized all neonates. In addition, one animal in the 300 mg/kg group also cannibalized a part of neonates but showed a lactating behavior on and after Day 2 of lactation, and 4 of 19 neonates survived. However, these abnormalities in lactating were not dose-dependent changes.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decreases in the number of corpora lutea and implantation sites
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
Details on results (F1)
of lactation was slightly low in the 1000 mg/kg group. However, these changes showed no statistically significant difference. There was no abnormality in the clinical signs of neonates.
(2) Morphology There was no morphological anomaly attributable to administration of the test compound. As the changes observed sporadically,
mulitiple anomalities from the external surface to visceral organs (systemic edema, defect of the second finger and hypoplasia of the fifth finger of the bilateral forelimbs, hypoplasia of the fifth finger of the bilateral hindlimbs, hypoplasia of the left lung, defect of the right lung) were observed in one animal in the 100 mg/kg group. In addition, as external anomalies, a kinked tail and systemic edema were observed in one animal each in the control group. For the visceral variations, thymic remnant in the neck or persistent left umbilical artery was sporadically observed in all groups including the control group, but the frequency was not different between groups.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no adverse effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
NOAEL: 1000 mg/kg for the parental males and offspring
300 mg/kg for the parental females
1) Effects on parent animals
Number of corpora lutea, implantation sites and
implantation index
-----------------------------------------------------------
Dose level (mg/kg/day)
0 30 100 300 1000
No. of corpora lutea (Mean± SD)
19.6±1.3 19.3±1.8 17.8±2.0 18.1±2.0 16.0±1.8**
No of implantation sites (Mean± SD)
18.8±1.4 18.3±1.1 17.6±1.9 17.8±1.8 15.9±1.7**
Significantly different from control (**: p < 0.01)
-----------------------------------------------------------
Applicant's summary and conclusion
- Conclusions:
- In a valid guideline study the reproductive and developmental toxicological NOAEL is considered as 1000 mg/kg/day for parental males and offspring; 300 mg/kg/day for parental females since decreases in the number of corpora lutea and implantation sites were observed in the 1000 mg/kg group.
- Executive summary:
In a valid guideline study the reproductive and developmental toxicological NOAEL is considered as 1000 mg/kg/day for parental males and offspring; 300 mg/kg/day for parental females since decreases in the number of corpora lutea and implantation sites were observed in the 1000 mg/kg group.
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