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EC number: 212-052-3 | CAS number: 756-79-6
- 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
Skin Irritation: not irritating (Ciba 1976)
Eye Irritation: Serious eye damage CAT 1 (worst case assumption, Ciba 1976)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
- Remarks:
- well documented study
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: rabbits (3 males; 3 females) of the Russian breed; no additional data
- Age at study initiation: no data
- Weight at study initiation: 1.7-2.0 kg
- Housing: housed singly in metal cages (overall dimensions 47x32x34 cm)
- Diet (e.g. ad libitum): standard diet of Nafag
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1°C
- Humidity (%): 55±5%
- Photoperiod (hrs dark / hrs light): 14 hours light/day - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved (right side) and abraded (shaved skin area on the left side was slightly scarified just before treatment)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: a gauze patch of 2.5 x 2.5 cm laden with the test substance was applied immediately to the prepared skin
- % coverage: not specified
- Type of wrap if used: the patch was covered with an impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified; the gauze patches were removed
- Time after start of exposure: 24 hours after application
SCORING SYSTEM: comparable to the OECD scoring system; the reaction of the skin was appraised upon removal during an observation period of 7 days. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all tested animals
- Time point:
- other: 24-48-72-hour
- Score:
- 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Only shaved sites considered for evaluation; 5 animals (3 males and 2 females) showed an erythema score of each 1, reversible within 48 hours (see Table 1)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all tested animals
- Time point:
- other: 24-48-72-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Only shaved sites considered for evaluation (see Table 2)
- Irritant / corrosive response data:
- see Table 1&2; a slight irritating effect was present on abraded sites (maximum score of 2 in only one animal after 24 hours), but fully reversible within 72 hours in all animals
Reference
Table 1: Erythema scores assuming (only shaved sites shown)
Time point |
Individual and mean erythema scores |
||||||
Male animals |
Male animals |
Mean all animals |
|||||
1st |
2nd |
3rd |
4th |
5th |
6th |
||
24 h |
1 |
1 |
1 |
1 |
0 |
1 |
0.83 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean 24-48-72 h |
0.3 |
0.3 |
0.3 |
0.3 |
0 |
0.3 |
0.28 |
Table 2: Edema scores (only shaved sites shown)
Time point |
Individual and mean edema scores |
||||||
Male animals |
Male animals |
Mean all animals |
|||||
1st |
2nd |
3rd |
4th |
5th |
6th |
||
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean 24-48-72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
- Remarks:
- well documented study
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: rabbits (3 males; 3 females) of the Russian breed; no additional data
- Age at study initiation: no data
- Weight at study initiation: 1.6-2.0 kg
- Housing: housed singly in metal cages (overall dimensions 47x32x34 cm)
- Diet (e.g. ad libitum): standard diet of Nafag
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1°C
- Humidity (%): 55±5%
- Photoperiod (hrs dark / hrs light): 14 hours light/day
Only rabbits showing normal ophthalmic findings were included in the test. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe
- Concentration (if solution): 100% - Duration of treatment / exposure:
- After application, the eyelids were held open for a few seconds
- Observation period (in vivo):
- up to 8 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes of 3 animals were rinsed 1 minute after application with physiologic saline
SCORING SYSTEM: comparable to the OECD scoring system
The reactions were appraised with a slit lamp after 1 and 6 hours, 1, 2, 3, 6 and 8 days; the results of washed eye animals are not considered hier because they are not comparable to the OECD guideline (evaluation of eye irritation). - Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hour
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days (one animal still showed a score of 1)
- Remarks on result:
- other: individual mean was 2.0, 1.7 and 1.7 for the 3 animals considered
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hours
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Individual means were 1.0, 0.3 and 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hour
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days (only one animal still present a score of 2)
- Remarks on result:
- other: Individual mean scores were 3.0, 2.0 and 2.9
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hour
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days (only one animal still present a score of 1)
- Remarks on result:
- other: Individual mean scores were 2.3, 1.5 and 2.0
- Irritant / corrosive response data:
- based on the irritation scores (see above and Table 1) and on the conjunctival redness in particular, the test substance is irritating to the rabbit eyes
- Interpretation of results:
- other: Results may lead to CAT 2A but reversibility investigation gap, hence worst case CAT 1 assumed.
Reference
Table 1: Draize scores
time |
Test animal |
Cornea |
Iris |
Conjunctiva |
|||
|
|
Opacity |
Area |
|
Erythema |
Edema |
Secretion |
After 1 hours |
First |
2 |
4 |
1 |
2 |
3 |
2 |
Second |
2 |
4 |
1 |
2 |
2 |
2 |
|
Third |
1 |
4 |
1 |
2 |
3 |
2 |
|
After 24 hours |
First |
2 |
4 |
1 |
3 |
3 |
2 |
Second |
2 |
4 |
1 |
3 |
2 |
2 |
|
Third |
2 |
4 |
1 |
3 |
3 |
2 |
|
After 48 hours |
First |
2 |
4 |
1 |
3 |
2 |
2 |
Second |
2 |
4 |
0 |
2 |
1 |
1 |
|
Third |
2 |
4 |
0 |
3 |
2 |
2 |
|
After 72 hours |
First |
2 |
4 |
1 |
3 |
2 |
2 |
Second |
1 |
4 |
0 |
1 |
0 |
0 |
|
Third |
1 |
4 |
0 |
2 |
1 |
0 |
|
After 8 days |
First |
1 |
4 |
0 |
2 |
1 |
0 |
Second |
0 |
0 |
0 |
0 |
0 |
0 |
|
Third |
0 |
0 |
0 |
0 |
0 |
0 |
|
24-72-72-hour mean (2-animals mean is calculated for those 2 animals showing the worst reactions |
First |
2.0 |
4.0 |
1.0 |
3.0 |
2.3 |
2.0 |
Second |
1.7 |
4.0 |
0.3 |
2.0 |
1.5 |
1.5 |
|
Third |
1.7 |
4.0 |
0.3 |
2.7 |
2.0 |
1.3 |
|
3-animals mean |
1.8 |
4.0 |
0.5 |
2.6 |
1.9 |
1.6 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008.
Skin Irritation: For skin irritation the key study conducted according to the draize protocol does not show sufficient scorings for skin irritation labeling according to Regulation 1272/2008.
Eye Irritation: Concerning eye irritation the most reliable study shows gradings lead to eye irritation cat. 2 but the reversible was not fully investigated up to day 21. Instead readings on day 8 (last day of investigation) show still effects in one animal. It can be assumed that due less severe readings on day 8 the effects will fully disappear at a later stage, but as this was not investigated and stays unclear. Therefore reversible can not fully be show and according to Regulation 1272/2008 the substance needs to be classified as CAT 1 eye damaging.
As a result DMMP is not considered to be classified as a skin irritant under Regulation (EC) No. 1272/2008 but as eye damaging CAT 1.
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