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EC number: 223-228-4 | CAS number: 3775-90-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.01.90 - 16.05.90
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-tert-butylaminoethyl methacrylate
- EC Number:
- 223-228-4
- EC Name:
- 2-tert-butylaminoethyl methacrylate
- Cas Number:
- 3775-90-4
- Molecular formula:
- C10H19NO2
- IUPAC Name:
- 2-(tert-butylamino)ethyl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- MATBAE 2-tert-Butylaminoethyl methacrylate >99% CAS No 37775-90-4 was supplied stabilised with 300ppm of EMHQ Monomethyl ether of hydroquinone CAS No 150-76-5
Constituent 1
- Specific details on test material used for the study:
- The test substance is a colourless to light yellow liquid at 20 °C and atmospheric pressure.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals
The animals used in this study are male New Zealand White rabbits (6 animals), provided by the Abbey of Bellefontaine (49122 Begrolles in Mauges, France).
Upon arrival at C.I.T., the animals were acclimated to local conditions for a minimum period of 5 days, during which they are observed daily. A systematic prophylactic treatment is undertaken in order to avoid any risk of coccidial infection The treatment was administered in the drinking water as a solution of Mucoxid (R) at a dose of 137.5 mg / kg / day in a volume of 10 ml / kg (Veda-Cogla, 45140 Saint Jean de la Ruelle, France) for 5 days of the acclimatization period.
On the day of treatment, the animals had an average weight of 2.5 ± 0.1 kg. They
are individually identified by a metal ear tag.
Environment
The study was carried out in a conventional animal area. The Environment was maintained during the acclimatization period and for the study as follows:
Temperature : 20+/- 3°C
Humidity : 50 +/- 20% relative humidity
Light cycle : 12 hours light and 12 hours dark
The temperature and humidity are recorded for each animal room. The air is not recycled it is filtered through an absolute filter.
The rabbits were housed individually in polystyrene cages equipped with a fodd contained and a water bottle.
The rabbits were fed a granular rabbit diet (No 112 C UAR 91360 Villemoisson-sur-Orge, France), ad libitum for the duration of the study. A certificate of analysis was included in the report. The drinking water was filtered through a 0.22 micron membrane. The water was regularly checked for bacteriological and chemical contamination
Animals
The animals used in this study are male New Zealand White rabbits (6 animals), provided by the Abbey of Bellefontaine (49122 Begrolles in Mauges, France).
Upon arrival at C.I.T., the animals were acclimated to local conditions for a minimum period of 5 days, during which they are observed daily. A systematic prophylactic treatment is undertaken in order to avoid any risk of coccidial infection The treatment was administered in the drinking water as a solution of Mucoxid (R) at a dose of 137.5 mg / kg / day in a volume of 10 ml / kg (Veda-Cogla, 45140 Saint Jean de la Ruelle, France) for 5 days of the acclimatization period.
On the day of treatment, the animals had an average weight of 2.5 ± 0.1 kg. They
are individually identified by a metal ear tag.
Environment
The study was carried out in a conventional animal area. The Environment was maintained during the acclimatization period and for the study as follows:
Temperature : 20+/- 3°C
Humidity : 50 +/- 20% relative humidity
Light cycle : 12 hours light and 12 hours dark
The temperature and humidity are recorded for each animal room. The air is not recycled it is filtered through an absolute filter.
The rabbits were housed individually in polystyrene cages equipped with a fodd contained and a water bottle.
The rabbits were fed a granular rabbit diet (No 112 C UAR 91360 Villemoisson-sur-Orge, France), ad libitum for the duration of the study. A certificate of analysis was included in the report. The drinking water was filtered through a 0.22 micron membrane. The water was regularly checked for bacteriological and chemical contamination
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Preparation of the Animals
Before treatment the flanks of the animals were clipped using electric clippers. The rabbits were then checked to ensure there were no signs of skin irritation prior to treatment.
Treatment
0.5ml of the test substance was placed on hydrophilic gauze of 6cm2, which was then applied to the right side of each animal. The left flank where no test substance was applied served as the control. The gauze was secured on the skin by menas of a semi-ventilated hypoallergenic adhesive dressing. - Duration of treatment / exposure:
- The test substance was applied to the skin for three minutes for rabbits No 4-6 and 4 hours for rabbits No 1-3. The skin was not washed when the gauze was removed
- Observation period:
- The skin reactions were evaluated 1 hour and then 24, 48 and 72 hours after removal of the gauze to assess the reversibility of the reactions, following the scoring system found in guideline OECD 404. Obervations were continued until day 9.
- Number of animals:
- Male New Zealand white rabbits, 3 exposed for 3 minutes and 3 exposed for 4 hours.
- Details on study design:
- The test substance was applied to the skin for three minutes for rabbits No 4-6 and 4 hours for rabbits No 1-3. The skin reactions were evaluated 1 hour and then 24, 48 and 72 hours after removal of the gauze to assess the reversibility of the reactions, following the scoring system found in guideline OECD 404. Obervations were continued until day 9.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- 4 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks:
- Two animals sacrificed at day 2
- Irritation parameter:
- edema score
- Remarks:
- 4 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks:
- Two animals sacrificed at day 2
- Irritant / corrosive response data:
- RESULTS
Application for 3 minutes:
After one hour, a visible erythema was observed in 3 animals. After 24 hours the erythema remains clearly visible and a slight edema was apparent. After 48 hours, the erythema became moderate to severe, the oedema remained slight. After 72 hours the oedema disappeared in one animal but the other lesions persisted.
At day 5, no oedema was observed, the oedema regressed in one animal. During days 6 to 8 erythema regressed and disappeared with dryness of the skinj noted on three animals. By day 9 no skin lesion were recorded.
Application for 4 hours:
After one hour, a severe erythema or signs of necrosis associate has a slight edema was seen in one animal and severe oedema in 2 animals was seen. After 24 hours, signs of necrosis were seen in two animals which were terminated at that time. The skin reactions in the third animal were significant up to day 5 but then regressed and disappeared by day 9.
As necrosis was seen which resulted in the termination of 3 of the four rabbits, the classification was for R34, this is Category 1C against the EU CLP(GHS) criteria.
Any other information on results incl. tables
Table 1
Application for 3 minutes
Average scores calculated for each site
|
Observation |
Time |
|
|
Maximum |
|
1 hour |
24 hours |
48 hours |
72 hours |
Possible score |
Erythema |
2.0 |
2.0 |
3.0 |
3.0 |
4 |
Oedema |
0.0 |
2.0 |
2.0 |
1.3 |
4 |
Average scores calculated from the scores at 24.48 and 72 hours four each animal
|
Animal No |
|
|
Maximum score |
|
04 |
05 |
06 |
Per site |
Erythema |
2.7 |
2.7 |
2.7 |
3 for 3 days |
Oedema |
2.0 |
1.3 |
2.0 |
2 for 3 days |
Tables 2/3
Application for 3 minutes
No of Rabbits |
Day 1 |
Day 2 |
Day 3 |
Day4 |
Day5 |
Day6 |
Day7 |
Day8 |
Day9 |
|
1hour |
24hour |
48hour |
72hour |
|
|
|
|
|
Erythema |
|
|
|
|
|
|
|
|
|
04 |
2 |
2 |
3 |
3 |
3 |
2/S |
1/S |
0/S |
0 |
05 |
2 |
2 |
3 |
3 |
3 |
2/S |
1/S |
0/S |
0 |
06 |
2 |
2 |
3 |
3 |
2/S |
2/S |
1/S |
0/S |
0 |
Oedema |
|
|
|
|
|
|
|
|
|
04 |
0 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
05 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
06 |
0 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
S= Dryness of the skin
Table 4
Application for 4 hours
Average scores calculated for each site
|
Observation |
Time |
|
|
Maximum |
|
1 hour |
24 hours |
48 hours |
72 hours |
Possible score |
Erythema |
3.3(1) |
3.7(1) |
3.0 |
3.0 |
4 |
Oedema |
3.3 |
4.0 |
3.0 |
2.0 |
4 |
(1) Calculated on the basis N = 4
Average scores calculated from the scores at 24.48 and 72 hours four each animal
|
Animal No |
|
|
Maximum score |
|
04 |
05 |
06 |
Per site |
Erythema |
(2) |
3.0 |
(2) |
Necrosis |
Oedema |
(2) |
3.0 |
(2) |
4 after 24 hours |
(2) = Animal sacrificed on day 3
Tables 5/6
Application for 4 hours
No of Rabbits |
Day 1 |
Day 2 |
Day 3 |
Day4 |
Day5 |
Day6 |
Day7 |
Day8 |
Day 9 |
|
1hour |
24hour |
48hour |
72hour |
|
|
|
|
|
Erythema |
|
|
|
|
|
|
|
|
|
01 |
N |
N |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
02 |
2 |
3 |
3 |
3 |
2 |
1/S |
0/S |
0/S |
0 |
03 |
4 |
N |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
Oedema |
|
|
|
|
|
|
|
|
|
01 |
4 |
4 |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
02 |
2 |
4 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
03 |
4 |
4 |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) |
(1) Animal sacrificed N=Necrosis S= Dryness of skin
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this experiment , taking into account the classification criteria at the time of the experiment 83/467/EEC, MATBAE is considered to be irrigating after 3 minute exposure but was corrosive to the skin of rabbits after 4 hour exposure. This would result in a classification under the EU CLP (GHS) classification criteria of category 1C.
- Executive summary:
SUMMARY
The study investigated if skin irritation can be induced by MATBAE (t-butylaminoethyl methacrylate) when evaluated in rabbits in accordance with the guideline No. 404 (OECD 1981) the study was carried out under the requirements for Good Laboratory Practice (OECD 1981). The interpretation of the results was performed according to the criteria of classification described in the Directive 83/467/EEC of 29 July 1983 on the fifth adaptation to technical progress
of Directive 67/548/EEC.
Materials and Methods
A single dose of 0.5 ml of the product has been prepared on a dry gauze then applied to a skin surface mowed 6 cm2 in 6 males New Zealand White rabbits. The product was kept in contact with skin for 3 minutes in 3 animals and 4 hours in 3 other animals
using a semi-dressing occlusive application. The skin reactions were observed at
1 hour, 24, 48 and 72 hours after the removal of the dressings and then daily to monitor reversibility or irreversibility. No rinsing of the product from the skin was made after the removal of the dressingResults
Application of the product for 3 minutes:
The reactions that were consistently observed were of marked skin erythema and oedema (individual scores of 2 or 3) for at least 72 hours in three animals. Dryness of skin was also observed at the site of application of the product between day 5 and day 8. By day 9, all lesions skin effects are reversible.
Application of the product for 4 hours:
The observed skin reactions were severe (necrosis in one animated after
1 hour, and in 2 animals after 24 hours, with severe oedema in 3 animals). The skin lesions on the rabbit which showed no evidence of necrosis, were reversible by day 9. The other two animals were sacrificed after 24 hours due to the serious nature of the corrosive effects on the skin.Conclusion
Under the conditions of this experiment , taking into account the classification criteria at the time of the experiment 83/467/EEC, MATBAE is considered to be irrigating after 3 minute exposure but was corrosive to the skin of rabbits after 4 hour exposure. This would result in a classification under the EU CLP (GHS) classification criteria of category 1C.
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