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EC number: 946-308-7 | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 23, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Version / remarks:
- 40 CFR Part 798.4100
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted
Test material
- Reference substance name:
- Cocamidopropyl PG-dimonium chloride
- Cas Number:
- 136920-08-6
- Molecular formula:
- C20-30H43-63ClN2O2 range
- IUPAC Name:
- Cocamidopropyl PG-dimonium chloride
- Test material form:
- other: aqueous solution
- Details on test material:
- Cocamidopropyl PG-dimonium chloride
Lot# PC-329-37
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Healthy USDA certifiedguinea pigs were received from Davidson's Mill Farm. 25 guinea pigs (25males, 0 females) were selected for test based on body weight and health status. Control and test animals were from the same shipment.
acclimation period: 12 days
Caging - gang-caged in suspended stainless steel caging with mesh floors
Room temperature 19-21C
Feed: purina guinea pigs pellets ad-libitum
Water: tap water supplied by automatic water system
Identification: a number was allocated to each rabbit on receipt.
Instillation day: the first induction dose was applied on November 29,1989. after a two week rest period the challenge dose was applied on December 13, 1989. There was no need for a re-challenge.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4mL
- Day(s)/duration:
- 6 hours of exposure for each 0.4mL dose. Three repeated doses every week
- Adequacy of induction:
- other: highest concentration that produce no erythemic or edematous response
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4mL neat material
- Day(s)/duration:
- 6hr exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- Animal Selection
Male, Hartley strain, albino guinea pigs allowed to adapt to the laboratory for 12 days. 25 guinea pigs were selected for testing on the basis of good health and body weight. Each guinea pig was uniquely identified with an ear tag and study number. The animals weighed 289-396 grams.
Maximum on-irritating dose
prior to the period of induction, the maximum non-irritating concentration of the test material was determined. The dorsal thoracolumbar region of 2 guinea pigs was rid of hair by clipping. The back of each guinea pig was divided into 4 test sites. (2 sites on each side of the midline). The test material was applied neat and was also diluted with distilled water to yield concentrations of 75, 50 and 25%. Two guinea pig each received the same dose concentrations. by applyng 0.5mL of each respective concentration to pre-assigned delineated test sites on each animal. Each site was covered with 2.5cm2 diameter gauze patch secured in place with hypoallergenic adhesive tape. After 6 hrs of exposure the patches were removed. 24 hrs after initial application, readings were made of local reactions. (erythema and edema). From these results the highest non-irritating concentration that produced ni erythemic or edematous response in 2 guinea pigs and was the concentration used for Induction and Challenge.
Induction and challenge
10 guinea pigs were assigned to the tes group and ten guina pigs were assigned to the control group (0.08% DNCB in 95% ethanol). Immediately prior to test initiation and prior to each induction and each challenge dose, the hair was removed from the dorsal thoracolumbar region of each guinea pig by clipping. One Hilltop chamber was placed over the back of each guinea-pig. 0.4mL of test material was placed into each chamber. after dosing, the test and positive control guinea pigs were each respectively divided into subgroups and placed into stainless steel gang cages. The chambers were removed after six hours of exposure. 24 and 48 hrs after each induction application readings were made of local reactions. This process was repeated once each week until a total of three dose applications had been made. 14 days after the third application, a challenge dose was applied to a naive site on the left of each guinea pig and to the five naive control animals. This site was recorded for a sensitization response for erythema and edema at 24 and 48 hrs after challenge according to the system described in the attached report. - Challenge controls:
- (0.08% DNCB in 95% ethanol) 10 guinea pigs
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Induction phase
Faint to moderate erythema was observed at all positive control sites 24 and 48 hrs after the second and third application. One site exhibited severe eythema with slight eschar
Challenge phase
at 24hrs, all positive control sites had faint, unusually confluent erythame. This condition persisted at 5 sites through 48 hrs and diminished to very faint erythema at the remaining 5 sites.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 mL neat material
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Four guinea pigs exhibited very faint non-confluent erythema 24 hrs after challenge. The remaining 6 treated sites were clear. By 48 hrs only 2 sites still had signs of erythema. All others were clear.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.4mL undiluted
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- At 24 hrs, all positive control sites had faint, usually confluent erythema. This condition persisted at 5 sites through 48 hours and diminished at the remaining 5 sites
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: naive control animals
- Dose level:
- 0.4 mL undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- 3 of 5 previously naive sites exhibited very faint, non-confluent erythema 24 and 48 hrs after challenge. The remaining two sites were clear of irritation at both time points.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these findings, the substance is not considered a contact sensitizer when applied as received, undiluted, once a week over a 3 week induction period.
The positive response to 0.08% DNCB in 95% Ethyl Alcohol validates the test system used in this study. - Executive summary:
A sample od cocamidopropyl PG-dimonium chloride (>30%) was tested as received, undiluted.
After establishing the highest non-irritating concentration to be 100%, a 3 week induction perdiod was initiated during which 10 young adult, male guinea pigs were treated with the test material and 10 were treated with 0.08% Dinitrochlorobenzene DNCB in 95% ethyl alcohol (positive control). During the induction period the test animals were dosed once a week until a total of three dose applications was achieved. 14 days after the third application a challenge dose was applied to a naive site on each guinea pig and approximately 24 and 48 hrs later the animals were scored for a sensitization response.
A naive control group of 5 animals was maintained under the same environmental conditions and treated with the test material at challenge only.
All guinea pigs appeared active and healthy during the test. There were no signs of gross toxicity, adverse phamacologic effects or abnormal behavior. All animal gained weight.
Induction phase
test animals: during induction, faint to moderate erythema was observed at all test animals sites 24 and 48 hrs after the second and third dose applications
positive control: faint to moderate erythema was observed at all positive control sites 24 and 48 hrs after the second and third dose application. One site exhibited severe erythema with slight eschar.
Challenge phase
test animals: 4 guinea pigs exhibited very faint non confluent erythema 24 hrs after challenge. The remaining 6 treated sites were clear. By 48 hours only 2 sites still had signs of erythema. all other sites were clear.
naive control animals: 3 of5 previously naive exhibited very faint, non-confluent erythema 24 and 48 hrs after challenge. The remaining two sites were clear of irritation at both time points.
positive control animals: at 24 hrs, all positive had faint, usually confluent erythema. This condition persisted at 5 sites through 48 hrs and diminished to very faint erythema at the remaining 5 sites.
The incidence and severity of irritation (sensitization response) after challenge test were as follow:
incidence incidence severity severity 24hrs 48hrs 24hrs 48hrs test animals 4/10 2/10 0.5 0.5 positive control animals 10/10 10/10 1 0.75 naive animals 3/5 3/5 0.5 0.5 Based on these findings, the substance is not considered a contact sensitizer when applied as received, undiluted, once a week over a 3 week induction period.
The positive response to 0.08% DNCB in 95% Ethyl Alcohol validates the test system used in this study.
positive control
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