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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 June 1999- 05 July 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain as cited in the study report: Himalayan/Chbb:HM (outbred strain)
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.4 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm2
- Diet: Kliba-Labordiet (Klingenthalmuehle AG, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark/hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served for control
- Amount / concentration applied:
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
reading time points: 1, 24, 48 and 72 h, and day 7 - Number of animals or in vitro replicates:
- 1 animal (female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM: scoring of the findings was done as recommended by the OECD guideline, according to the Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: corneal opacity grade 3 still was seen at the end of the observation period, i.e. at day 7.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hrs
- Remarks on result:
- other: alteration of the iris grade 1 was seen at 24, 48 and 72 h; due to severe lesions of the eye on day 7, the iris could not be assessed at that time point.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: conjunctival redness grade 3 still was seen at the end of observation period of 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: chemosis grade 3 still was seen at the end of observation period of 7 days.
- Irritant / corrosive response data:
- The animal displayed corneal opacity, conjunctival redness and chemosis as well as discharge during to whole period of observation. Regarding the iris, a reaction grade 1 was seen at 24, 48 and 72 h; because of additional alterations, the iris could not be evaluated at day 7.
A discharge grade of 3 was seen, i.e. with moistening of the lids and hairs affecting a considerable area around the eye, still was seen at the end of observation period of 7 days. - Other effects:
- The additional alterations almost consisted of suppuration, bloody discharge, loss of corneal tissue, and discolouration of parts of the conjunctiva and nictitating membrane (yellow-brown to white). These alterations were seen all over the reading time points, from 1 h to day 7.
Any other information on results incl. tables
Table 1: Details on findings and scores:
Readings |
animal |
cornea score |
iris score |
conjunctiva redness |
chemosis |
discharge | additional alterations |
1 hr |
1 |
2 |
0 |
2 |
2 |
2 |
bloody discharge, loss of corneal tissue, parts of conjunctiva and nictitating membrane yellow-brown discoloured (indicating necrosis in the view of the study director) |
24 hrs |
1 |
2 |
1 |
3 |
2 |
3 |
bloody discharge, loss of corneal tissue, parts of conjunctiva and nictitating membrane yellow-brown discoloured (indicating necrosis in the view of the study director) |
48 hrs |
1 |
2 |
1 |
3 |
2 |
3 |
bloody discharge, parts of conjunctiva and nictitating membrane yellow-brown/white discoloured (indicating necrosis in the view of the study director) |
72 hrs |
1 |
3 |
1 |
3 |
3 |
3 |
suppuration, bloody discharge, parts of conjunctiva and nictitating membrane yellow-brown/white discoloured (indicating necrosis in the view of the study director) |
7 d |
1 |
3 |
|
3 |
3 |
3 |
suppuration, bloody discharge, loss of corneal tissue, parts of conjunctiva and nictitating membrane white discoloured (indicating necrosis in the view of the study director). Due to the severity of the findings, the study was stopped. |
mean |
|
2.3 |
1 |
3 |
2.3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Taking into account the mean scores for corneal opacity, iris, conjunctiva redness and chemosis over the reading time points 24, 48 and 72 h, and regarding the severity of the additional lesions and the absence of reversibility, the test item is to be considered as causing serious damages to the eye according to current evaluation criteria.
- Executive summary:
DMPA was tested for eye irritation in one female rabbit according to the OECD TG 405 (1987). The test item was applied undiluted into the conjunctival sac of one eye. After 24 h exposure, the eye was washed and examined for signs of irritation at the following reading time points: 1, 24, 48 and 72 h, and day 7. Due to the severity of the findings, the test was stopped at day 7. The eye findings were assessed by scoring according to the Draize scoring system.
Severe occular lesions affecting the cornea, iris, conjunctiva and the lids were detected at all observation time points; thus, the effects were not reversible within the 7 day period of observation. Additional lesions also were reported, including severe discharge, suppuration, discharge with blood, and yellow-brown to white discolouration of the conjunctiva and nictitating membrane, which, according to the study director, indicated necrosis. No further animals needed to be tested.
Taking into account the mean scores for corneal opacity, iris, conjunctiva redness and chemosis over the reading time points 24, 48 and 72 h, and regarding the severity of the additional lesions and the absence of reversibility, the test item is to be considered as causing serious damages to the eye according to current evaluation criteria.
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