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EC number: 619-057-3 | CAS number: 94667-33-1
- 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:
- July - September 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
Test material
- Reference substance name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- EC Number:
- 619-057-3
- Cas Number:
- 94667-33-1
- Molecular formula:
- C29 H62 N O4 . C3 H5 O2
- IUPAC Name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- Reference substance name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- IUPAC Name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- Reference substance name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- IUPAC Name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- Reference substance name:
- Bardap 26
- IUPAC Name:
- Bardap 26
- Details on test material:
- The test material was Bardap 26 described as a clear, yellow liquid. The test substance was stored at 22°C in the dark in a fume hood.
The deviation in composition of the old test material to the current specifications is considered not to have any impact on the outcome of the study.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were 3-5 month old New Zealand White rabbits obtained from Hoechst AG, Kastengrund, Germany. The rabbits weighed 2.2-3.6 kg. The animals were housed individually, temperature was maintained at 20 ± 3°C and relative humidity was maintained at 50 ± 20% with a 12 hour light/dark cycle. The rabbits were fed Altromin 2123 Haltungsdiat - Kaninchen ad libitum, and provided with deionised chlorinated water ad libitum.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml undiluted test substance/site
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 per exposure period
- Details on study design:
- On the day prior to administration, the dorsal area and the trunk of each animal was clipped free of fur. Only animals with intact skin were selected for the test.
On the day of dosing, a wound plaster with a 2.5 x 2.5 cm pulp patch (Beiersdorf AG, Hamburg) was fixed on the prepared skin site of each animal. 0.5 ml of the undiluted test substance was administered under the plaster. For animals with 1- and 4-hour exposures the test area was covered with a semi-occlusive bandage. The exposure period was 3 minutes, 1 hour or 4 hours. Residual test material was gently removed from the test sites with lukewarm water.
Skin reactions were recorded 30-60 minutes, 24, 48 and 72 hours after removal of the dressings, and at 7 and 14 days. Reactions were scored according to the scoring system set out in OECD 404. Rabbits were observed for mortality daily.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.22
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritant / corrosive response data:
- Very slight to moderate erythema and barely perceptible to slight oedema was observed following the 3-minute exposure, persisting for up to 7 days. 14 days after patch removal the skin showed very slight, barely perceptible erythema. The test site was observed to be dry, chapped and discoloured light brown. One animal had hardened skin 72 hours after patch removal, and 7 days after patch removal fine and rough desquamation partially occurred.
Moderate to severe erythema was observed up to 7 days after exposure for 1 hour. Barely perceptible to slight oedema was observed up to 24 hours after the 1 hour exposure. In addition, the skin was discoloured light brown, hardened and arched. Rough desquamation was observed from day 7 onwards. Eschar formation was observed in 2 animals after termination, and swelling of the treated skin was observed in one animal.
Following 4 hours exposure, the skin showed well defined to moderate erythema and very slight to moderate oedema up to 72 hours after patch removal. Very slight, barely perceptible erythema and oedema were observed 7 days after patch removal. The test sites were hardened, discoloured red-brown and the patch site framed white. The skin showed well defined to severe erythema 14 days after patch removal. One animal showed a defined oedema; oedema formation could not be observed in the other 2 animals due to hardening of the test site skin. The skin was roughly and finely desquamated, hardened, arched and discoloured red-brown. One animal was observed to have an open wound, and eschar formation was observed in all animals. - Other effects:
- No other effects reported.
Any other information on results incl. tables
Table 1. Mean skin irritation scores after 3 minutes of exposure
If 3 animals or less |
*Mean score |
Maximum value |
Maximum duration of any effect |
Maximum value at the end of the observation period |
||
1 |
2 |
3 |
||||
erythema/eschar |
2.33 |
2 |
2.33 |
3 |
14 days |
1 |
oedema |
1.33 |
0 |
1.67 |
2 |
7 days |
0 |
*calculated on the basis of the scores at 24, 48, 72 hours for each animal |
Table 2. Mean skin irritation scores after 1 hour of exposure
If 3 animals or less |
*Mean score |
Maximum value |
Maximum duration of any effect |
Maximum value at the end of the observation period |
||
1 |
2 |
3 |
||||
erythema/eschar |
4 |
4 |
2.67 |
4 |
7 days |
0 |
oedema |
0.67 |
0.33 |
0.67 |
2 |
1 day |
0 |
*calculated on the basis of the scores at 24, 48, 72 hours for each animal |
Table 3. Mean skin irritation scores after 4 hours of exposure
If 3 animals or less |
*Mean score |
Maximum value |
Maximum duration of any effect |
Maximum value at the end of the observation period |
||
1 |
2 |
3 |
||||
erythema/eschar |
2 |
2 |
2 |
4 |
14 days |
4 |
oedema |
1.67 |
1.67 |
1.67 |
3 |
14 days |
2 |
*calculated on the basis of the scores at 24, 48, 72 hours for each animal |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded that the test substance is corrosive to rabbit skin after 1 and 4 hours exposure.
- Executive summary:
The acute skin irritant potential of Bardap 26 was investigated in nine New Zealand White rabbits. The rabbits were given a single topical application of 0.5 ml undiluted test substance/site under a semiocclusive dressing for either 3 minutes, 1 hour or 4 hours (3 rabbits per exposure period). The rabbits were observed for up to 14 days post-application.
Moderate skin irritation was observed after 3 minutes of exposure. The test substance was corrosive after 1 and 4 hours of exposure with necrosis, desquamation and scars observed at 14 days after both exposure periods. It was concluded that the test substance is corrosive to rabbit skin following 1 and 4 hours exposure, and should therefore be classified as Corrosive Category 1B according to Regulation (EC) No. 1272.
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