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EC number: 230-813-8 | CAS number: 7328-22-5
- 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
Endpoint summary
Administrative data
Description of key information
Butyldiglycol methacrylate is not considered to be a skin sensitizer according to OECD 406 (GLP) in guinea pigs. (Klimisch score: 1, Elf Atochem 1999)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.04.1999-01.09.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive No. 92/69/EEC, B.6, 31st July 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA test has not been conducted because adequate data from a Guinea pig maximization test (report date 1999) were already available (study scientifically not necessary - other informarion available)
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Animals
Species and sex: male and female guinea-pigs.
Strain and sanitary status: Hartley Cri: (HA) BR, Caesarian obtained, Barrier sustained - Virus
Antibody Free (COBS - VAF@). .
Reason for this choice: species generally accepted by regulatory authorities for this type of study.
The strain used has been shown to produce a satisfactory sensitization response using known
positive sensitizers.
Breeder: Charles River France, 76410 Saint-Aubin-Ies-Elbeuf, France.
Number: . one male and one female for the preliminary test, .30 animals (15 males and 15 females) for the main test.
Females were nulliparous and non-pregnant.
Allocation of the animals to the groups: on day -1, the animals were weighed and randomly
allocated to two groups: a control group 1 consisting of ten animals (five males and
five females) and a treated group 2 consisting of 20 animals (ten males and ten females).
Weight: on day 1, the animals of the main test were approximately 3 months old and had a mean
body weight ± standard deviation of 349 ± 10 g for the males and 345 ± 13 g for the females.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: ear-tattoo.
Environmental conditions
The conditions in the animal room were set as follows:
• temperature: 21 ± 2°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 hl12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records
were checked daily and filed. In addition to these daily checks, the housing conditions and
corresponding instrumentation and equipment are verified and calibrated at regular intervals.
During the acclimatization period and throughout the study, the animals were housed
individually in polycarbonate cages (48 cm x 27 cm x 20 cm) equipped with a polypropylene
bottle.
Dust-free sawdust was provided as litter (SICSA, 92142 Alfortville, France).
Bacteriological and chemical analyses of the sawdust, including the detection of possible
contaminants (pesticides, heavy metals), are performed regularly by external laboratories.
The results of these analyses are archived at CIT.
Food and water
During the study, the animals had free access to "106 pelleted diet" (UAR, 91360 Villemoissonsur Orge, France).
Food is analysed regularly by the supplier for composition and contaminant levels.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by external laboratories.
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Remarks:
- A homogenous solution was obtained at the maximum concentration on 75 % (w/w)
- Concentration / amount:
- Induction (treated group)
- intrademal injections: Butyldigylcol methacrylate at the concentration
of 25% (w/w) in corn oil,
. topical application: Butyldigylcol methacrylate undiluted.
Challenge (all groups)
. topical application: Butyldigylcol methacrylate undiluted. - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Remarks:
- A homogenous solution was obtained at the maximum concentration on 75 % (w/w)
- Concentration / amount:
- Induction (treated group)
- intrademal injections: Butyldigylcol methacrylate at the concentration
of 25% (w/w) in corn oil,
. topical application: Butyldigylcol methacrylate undiluted.
Challenge (all groups)
. topical application: Butyldigylcol methacrylate undiluted. - No. of animals per dose:
- Thirty guinea-pigs were allocated to two groups: a control group 1 (five males and five females) and a treated group 2 (ten males and ten females).
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitro chlorobenzene (DNCB)
- Positive control results:
- The species and strain which were used showed satisfactory sensitization response in 90 % animals treated with DNCB.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 % 2,4-Dinitro chlorobenzene (DNCB)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 % 2,4-Dinitro chlorobenzene (DNCB)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Butyldiglycol methacrylate is not considered to be a skin sensitizer according to OECD 406 in guinea pigs.
- Executive summary:
In a guinea pig maximization test acc. OECD guideline 406 with 10 male and 10 female Hartley Crl guinea pigs no clinical signs or death were noted during the study and no cutaneous reactions were observed after the challenge application.
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, Butyldiglycol methacrylate does not induce delayed contact hypersensitivity in guinea-pigs. Butyldiglycol methacrylate is not considered to be a skin sensitizer and is not classified under EU criteria.
Reference
Control Group |
|||||||||
Sex |
Animal No. |
24 h |
48 h |
||||||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
||||
|
|
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
Male |
91 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
92 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
93 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
94 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
95 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Female |
106 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
107 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
108 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
109 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
110 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Treated Group |
|||||||||
Sex |
Animal No. |
24 h |
48 h |
||||||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
||||
|
|
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
Male |
96 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
97 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
98 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
99 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
101 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
102 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
103 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
104 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
105 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Female |
111 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
112 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
113 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
114 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
115 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
116 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
117 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
118 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
119 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
120 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
LF : left flank (vehicle)
RF :right flank (undiluted test substance)
No cutaneous reactions were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One relevant, reliable (Klimisch score 1; reliable without restrictions) study is available for the sensitising potential of BDGMA.
In a dermal sensitisation study with BDGMA, 10 female and 10 male Hartley Cri. Guinea Pigs were tested using the method of Magnusson & Kligman (Guinea Pig Maximisation Test) Control group: 5 males and 5 females. In a pretest, BDGMA was shown to be not irritating.
Induction (treated group)
- intradermal injections: Butyldigylcol methacrylate at the concentration of 25% (w/w) in corn oil,
. topical application: Butyldigylcol methacrylate undiluted.
Challenge (all groups)
. topical application: Butyldigylcol methacrylate undiluted.
Positive control: 2,4-Dinitro chlorobenzene (DNCB)
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, Butyldiglycol methacrylate does not induce delayed contact hypersensitivity in guinea-pigs. Butyldiglycol methacrylate is not considered to be a skin sensitizer.
Migrated from Short description of key information:
One relevant, reliable (Klimisch score = 1) and adequate study is available.
Justification for selection of skin sensitisation endpoint:
Guideline study OECD 406, GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Justification for selection of respiratory sensitisation endpoint:
Inhalation is no relevant route of exposure.
Justification for classification or non-classification
There are currently no conclusive indications for a classification of BDGMA as skin sensitiser according to regulation (EC) 1272/2008 and the former European directive on classification and labelling 67/548/EEC.
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.
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