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EC number: 202-974-4 | CAS number: 101-77-9
- 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
Endpoint summary
Administrative data
Description of key information
Based on several studies the test substance is not regarded as irritating to eyes and skin.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- The test procedure was based on the description in the Code of Federal Regulations 16 (commercial practices) Chapter II, part 1500.41, January 1, 1977.
Six male albino rabbits were treated with test substance at two abraded and two intact sites of the skin. After 24 hours the occluded patch was removed and the first reading was done. After 72 hours the second reading was performed and the primary dermal irritation index was determined. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Weight: 2 - 2.5 kg
Individual housing. - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hour
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE:
Four areas, two on each side of the rabbit´s back, approximately 10 cm apart, were utilized for substance administration. The hair on the backs of the animals was removed with an electric clipper. Two of the four sites were abraded, two were left intact. Abrations were made with a 24-gauge hypodermic needle and consisted of three superficial incisions 1 cm long and 0.5 cm apart. Abrasions were made to the stratum corneum.
EXPOSURE:
0.5 g of solid test substance was applied directly to a coverlet, dissolved in water and applied using a surgical gauze pad (1"x1"). The entire trunk was wrapped with an impervious material for the 24-h exposure period.
READING:
After 24 h the patches were removed and remained off for the duration of the experiment. Readings were performed 1, 24 and 72h following the exposure period.
INTERPRETATION:
An average irritation score was calculated for intact and abraded skin by adding the total irritation scores at 24 and 72 divided by the number of values. The primary dermal irritation index was determined by averaging the average irritation scores of the intact and abraded skin.
Two negative (blank preparation and destilled water) and a positive control (5% sodium lauryl sulfate) were also tested. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0.08
- Remarks on result:
- other: As the 48h timepoint was not assessed, the mean of 24 and 72 h is indicated.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- The PDII reveals a mild irritating effect of the test substance. The effect was only observed in abraded skin. However, a similar mildly irritating effect was observed in control animals on abraded skin.
The positive control (sodium lauryl sulfate) resulted in severe skin irritation on intact and abraded skin (PDII 6 or 5.5). - Interpretation of results:
- GHS criteria not met
Reference
MDA did not cause dermal irritation on New Zealand albino rabbits after topical application.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- The procedure conforms to that described in the Code of Federal Regulations 16 Commercial practices Chapter II, part 1500.42, January 1, 1977. Six albino New Zealand rabbits were used for each test substance. One hour prior to instillation of the test substance, the ocular irritation grades were determined using a modified Draize grading system for ocular lesions. In addition both eyes of each rabbit were stained with 2% sodium fluorescein and examined to confirm the absence of corneal lesions. 0.1 mL of flake was placed in one eye of the animals. The eyes are examined at 24, 48, and 72 hours.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- the eyes remained unwashed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation responses were observed in the control eyes. Details on irritation responses in the exposed eyes are reported in table 1.
- Interpretation of results:
- GHS criteria not met
Reference
Table 1: Draize scoring of ocular irritation after treatment with test substance
Time point
|
Observations
|
Animal No |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
||
24 h |
Cornea |
0 |
0 |
2 |
2 |
1 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
2 |
2 |
2 |
2 |
2 |
2 |
|
Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
|
48 h
|
Cornea |
0 |
0 |
1 |
1 |
1 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
1 |
1 |
2 |
2 |
2 |
1 |
|
Chemosis |
0 |
0 |
1 |
1 |
1 |
0 |
|
72 h
|
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
1 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean (24-48-72 h) |
Cornea |
0.0 |
0.0 |
1.0 |
1.0 |
0.67 |
0.67 |
Iris |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Conjunctivae |
1.0 |
1.0 |
1.33 |
1.33 |
1.33 |
1.33 |
|
Chemosis |
0.33 |
0.33 |
0.67 |
0.67 |
0.67 |
0.67 |
|
Mean (24-48-72 h) for all 6 rabbits |
Cornea |
0.56 |
|||||
Iris |
0.0 |
||||||
Conjunctivae |
1.22 |
||||||
Chemosis |
0.56 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In summary, the available animal data on irritation/corrosion is dated, and no full GLP/OECD guideline study is available. Nevertheless, taken together, the information is sufficient to conclude that classification for irritation is not warranted..
Skin irritation:
In the key study (performed according to CFR 16, II, 1500.41), MDA (0.5 g) did not cause erythema or edema on intact skin under occlusive conditions (Draize score = 0). Mild erythema was observed on abraded skin (draize score = 0.17) which was fully reversible within 72 h (Allied Chemical Corp, 1978). According to EU and GHS standards, no classification is required for skin irritation/corrosion.
Similar results were observed a supporting study with mean Draize scores of 0.5 for erythema on intact skin. This mild effect was fully reversible within 72 h (Huntsman, 1973).
Additionally, a short report is available in which MDA was estimated to be not irritating (Dow, 1954). Undiluted MDA was tested on intact and abraded skin in 1 animal each. Very slight scaliness was described on the intact skin, and slight reversible hyperemia was observed on the abraded skin. Furthermore, in an insufficiently reported study by BASF (1956), no more than slight reversible erythema was observed on the skin of rabbits exposed to various dilutions of MDA. The reported data were not sufficient to derive appropriate Draize scores.
In summary, animal data indicate that there is no need for classification of MDA as an irritant to the skin according to EU- and GHS-directives. Human data on irritating effects to skin are not available.
Eye irritation:
In a eye irritation study (performed according to CFR 16, II, 1500.41) only mild eye reaction was observed in rabbits following instillation of 100 mg MDA into the conjunctival sac. The effects were fully reversible within 72 hours in 5 out of 6 animals (Allied Chemical Corporation, 1978).
Similar mild eye reactions were observed in a supporting study with 100 mg MDA. Following application into the conjunctival sac mild irritation was reversible in 5 of 6 animals, in one animal reversion occurred between day 3 and 7 (Huntsman, 1973).
Additionally a short report is available in which MDA-instillation into the eye of rabbits resulted in a slight transient conjunctivitis (Dow Chemical Corporation, 1954).
BASF (1959) reported slight erythema (scale=1) and bleeding from nictating membrane in rabbit eyes within 48 h observation period. These signs were fully reversible within 7 days. No information was provided for 72 h, so draize scoring was not possible.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for eye or skin irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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