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EC number: 213-139-9 | CAS number: 926-63-6
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 07 June - 21 June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl(propyl)amine
- EC Number:
- 213-139-9
- EC Name:
- Dimethyl(propyl)amine
- Cas Number:
- 926-63-6
- Molecular formula:
- C5H13N
- IUPAC Name:
- dimethyl(propyl)amine
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: K322/1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain as cited in the study report: White New Zealand/Chbb:NZW (SPF)
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 4, 2.8, 2.9 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm2
- Diet: Kliba-Labordiet (Klingenthalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal and day
- Water: 250 mL tap water per animal and day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark/hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- (24 hrs prior to testing)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied: 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
Reading time points: 1, 24, 48 and 72 h, day 7 and day 14 - Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and stretch (Fixomull adhesive fleece, Baiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing: after removal of the dressing, the application site was washed with Lutrol followed by Lutrol in water (1:1).
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scoring was done as specified by the OECD guideline, according to the Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: erythema grade 2 still was seen after 14 days.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: erythema grade 1 still was seen after 14 days.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: erythema grade 1 was seen at each of reading time points 1, 24, 48 and 72 hrs, with full reversibility reached at day 7.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: at day 14, 2/3 animals still showed erythema grade 1 and 2, respectively.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: edema grade 1 still was seen at day 14.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: edema grade 1 was seen at reading time points 48 h, 72 h, and at day 7 where it was accompanied by scaling. The finding was no more evident at day 14.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: this animal showed no edema at all.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 1/3 animals still showed edema grade 1 accompanied by scaling at day 14.
- Irritant / corrosive response data:
- Slight (1/3 animals) to moderate (2/3 animals) erythema was seen after 1 h. At 24 h, erythema became severe in one case and remained moderate and slight in the 2 other animals, respectively. At 48 and 72 h, 2/3 animals has severe erythema whereas the third animal still showed a slight effect. After 7 days, the two cases of severe erythema turned back to moderate whereas full reversibility was noticed for the third animal. After 14 days, one animal still showed moderate erythema whereas in the other one, the effect turned back to slight.
Regarding edema, whereas no effect was seen at reading time point 1 h, slight edema appeared in 1/3 animals at 24 h, and in 2/3 animals at 48 h. The effect in the 2 animals lasted until day 7 and was further accompanied by scaling. At day 14, only 1 of these 2 animals still showed edema with scaling. - Other effects:
- scaling seen at day 7 (2/3 animals) and at day 14 (1/3).
Any other information on results incl. tables
Table 1: Details on findings and scores:
Animal |
Erythema |
Edema |
|
1h |
1 |
2 |
0 |
|
2 |
2 |
0 |
|
3 |
1 |
0 |
24 hrs |
1 |
3 |
1 |
|
2 |
2 |
0 |
|
3 |
1 |
0 |
48 hrs |
1 |
3 |
1 |
|
2 |
3 |
1 |
|
3 |
1 |
0 |
72 hrs |
1 |
3 |
1 |
|
2 |
3 |
1 |
|
3 |
1 |
0 |
7 d |
1 |
2 |
1 + severe scaling |
|
2 |
2 |
1 + scaling |
|
3 |
0 |
0 |
14 d |
1 |
2 |
1 + scaling |
|
2 |
1 |
0 |
|
3 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- DMPA was tested for skin irritation in rabbits, under semi-occlusive conditions, according to the OECD TG 404 (1992). After 4 h exposure, the animals were observed during 14 days, with the skin being examined for signs of irritation at the following reading time points: 1, 24, 48 and 72 h, day 7 and day 14. The skin findings were assessed by scoring according to the Draize scoring system.
All 3 animals showed slight to severe erythema from 1 to 72 h; at day 7 and 14 slight to moderate erythema still was noticed in 2/3 animals, indicating that full reversibility was not reached at the end of the observation period of 14 days.
Slight edema appeared in 1/3 animals after 24 h and was seen in 2/3 animals at 48 h, 72 h and at day 7. At day 14, 1/3 animal still displayed slight edema. At 7 and 14 day, edema was accompanied by scaling.
Taking into account the mean erythema and edema scores obtained from all 3 animals over the reading time points 24, 48 and 72 h, and regarding the absence of full reversibility at day 14, the test item is to be considered as a skin irritant according to current evaluation criteria.
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