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EC number: 480-680-7 | CAS number: 120128-90-7
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15. Nov. 2004 - 17. Dec. 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
- Species:
- guinea pig
- Strain:
- other: Pirbright White, BOR DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- Species: guinea pig
Breed: Pirbright White, BOR DHPW
Breeder: Harlan Winkelmann, Borchen, Germany
Date of receipt: 2004-11-03
Sex: female
Number: 20 (test group 10, control group 5, pilot experiment 5)
Body weights: 313.3 g - 415.6 g
Age: - 4 weeks on delivery
Identification: dye marks and cage numbers
Diet: Altromin International, Lage, Germany, 3022 - 1420
Water: Drinking water for the animals consisted of normal tap water from municipal sources: Stadtische Werke Krefeld AG, Abt. 2 TGW, 47804 Krefeld, Germany. The composition of the water is regularly determined. The data are retained in the archive. The water was supplied to the animals ad libitum via drinking bottles with rubber stoppers and steel pipes.
Bedding Material: Lignocel BK 10/20, Rettenmaier, Jagstzell, Germany
Husbandry: The animals were housed with 2 or 3 animals in Makrolon®-cages No.4. A non-barrier system with air conditioning was used. The air conditioning had the following nominal values: Temperature: 22°C ± 3°C, Humidity: 30 % - 70 %, Air exchange: 8 times/hour. Climate control was run automatically. The lightening was in a 12-hour light/dark-cycle. Temperature and humidity were recorded continuously using a thermohygrometer, Lambrecht GmbH, Gbttingen, Germany. In cause of a technical default of the thermohygrometer the climate could not be recorded on the 2nd, 3rd, 4th and 5th of December 2004. The humidity was lower then 30 % from the 6th to 13th December 2004. These deviations are not supposed to have any significant effect on the experimental result. - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Pilot experiment:
Intradermal: 0.1 ml of 5.0 %, 3.5 %, 2.0 % and 0.5 % (w/w) dilution in saline (0.9 % NaCI solution).
Dermal: soaked patch with 100 %, 75 %, 50 % and 25 % (w/w) of the test substance in saline.
Challenge: duhring chamber with 50 % and 30 (w/w) of the test substance in saline.
Main study:
Intradermal: 0.1 ml of 3.5 % (w/w) solution of the test substance in saline.
Dermal: soaked patch with the undiluted test substance.
Challenge: duhring chamber with 30% (w/w) solution of the test substance in saline. - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Pilot experiment:
Intradermal: 0.1 ml of 5.0 %, 3.5 %, 2.0 % and 0.5 % (w/w) dilution in saline (0.9 % NaCI solution).
Dermal: soaked patch with 100 %, 75 %, 50 % and 25 % (w/w) of the test substance in saline.
Challenge: duhring chamber with 50 % and 30 (w/w) of the test substance in saline.
Main study:
Intradermal: 0.1 ml of 3.5 % (w/w) solution of the test substance in saline.
Dermal: soaked patch with the undiluted test substance.
Challenge: duhring chamber with 30% (w/w) solution of the test substance in saline. - No. of animals per dose:
- main study: test group 10 animals, control group 5 animals.
- Details on study design:
- RANGE FINDING TESTS: Pilot Experiment:
The purpose of the pilot experiment was to determine which concentration of the test substance 1. led to slight irritation after intradermal applicatio (determination of the maximum compatible dose), 2. led to slight irritation after dermal application and 3. can just be applied dermally without leading to skin irritation (subirritative dose).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and dermal)
- Exposure period: Dermal induction (for 48 h) 7 days after induction by Intradermal injection
- Test groups: 1 with 10 animals
- Control group: 1 with 5 animals
- Frequency of applications: once
- Concentrations: Intradermal: 0.1 ml of 3.5 % (w/w) solution of the test substance in saline. Dermal: soaked patch with the undiluted test substance. Challenge: duhring chamber with 30% (w/w) solution of the test substance in saline.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: at day 21 of the application period
- Exposure period: 24 hours
- Test groups: 1 with 10 animals
- Control group: 1 with 5 animals
- Site: left flank
- Concentrations: 30 % (w/w) dilution of the test substance in saline
- Evaluation (hr after challenge): 24 h and 48 h after end of challenge exposure
OTHER: - Positive control substance(s):
- yes
- Remarks:
- The corresponding validation experiment produced a sensitisation rate of 70 % with the reference substance 2-mercaptobenzothiazole showing the sensitivity of the test system.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The observed sensitisation rate of 0 % indicates that the test substance Formamidopropyldimethylbetaine is a non-sensitising compound in this test system.
- Executive summary:
For labelling and classification purposes the test substance Formamidopropyldimethylbetaine was tested regarding its skin sensitisation potential. The test was performed according to the stringent protocol of Magnusson and Kligman, in which adjuvant is used to elicit an immunologic reaction. The challenge application was executed with Duhring chambers to aim for better, i.e. more exaggerated, exposure conditions. The test protocol is in compliance with the OECD Guideline for the Testing of Chemicals No. 406 Skin Sensitisation (1992). The maximum compatible doses for the intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment. In the main experiment ten (10) female guinea pigs of the strain "Pirbright White" were treated intradermally with 0.1 ml of a 3.5 % (w/w) dilution of the test substance in saline. For the dermal induction the undiluted test substance was used. Intradermal application of the 3.5 % (w/w) dilution of the test substance in saline caused slight to moderate erythema and edema formation and the topical application of the undiluted test substance caused slight erythema and edema formation. In the challenge application Duhring chambers with a 30 % (w/w) dilution of the test substance in saline were used, a test concentration which was definitely non-irritating. Besides crust formation at the injection sides after intradermal application with FCA no other
systemic toxic symptoms or toxic reactions were observed at any time during the study. Body weight development of the animals was positive and within normal ranges. In the challenge no visible changes on the skin (no erythema and no edema) were observed at any time point; i.e. there was no positive challenge result in the test and the control group animals. Thus, the sensitisation rate was 0 %. Therefore, the test substance Formamidopropyldimethylbetaine has to be regarded as non-sensitising under the applied test conditions when exposed to the skin of experimental animals.
Reference
Challenge results
Animal number |
Code |
Sex |
24 hours |
48 hours |
||
Erythema |
Edema |
Erythema |
Edema |
|||
Test Group |
|
|
|
|
|
|
1 |
lv |
female |
0 |
0 |
0 |
0 |
2 |
Rv |
female |
0 |
0 |
0 |
0 |
3 |
Lh |
female |
0 |
0 |
0 |
0 |
4 |
Rh |
female |
0 |
0 |
0 |
0 |
5 |
2xv |
female |
0 |
0 |
0 |
0 |
6 |
Lv |
female |
0 |
0 |
0 |
0 |
7 |
rv |
female |
0 |
0 |
0 |
0 |
8 |
Lh |
female |
0 |
0 |
0 |
0 |
9 |
Rh |
female |
0 |
0 |
0 |
0 |
10 |
2xv |
female |
0 |
0 |
0 |
0 |
Control Group |
|
|
|
|
|
|
1 |
Lv |
female |
0 |
0 |
0 |
0 |
2 |
Rv |
female |
0 |
0 |
0 |
0 |
3 |
Lh |
female |
0 |
0 |
0 |
0 |
4 |
Rh |
female |
0 |
0 |
0 |
0 |
5 |
2xv |
female |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For labelling and classification purposes the test substance Formamidopropyldimethylbetaine was tested regarding its skin sensitisation potential. The test was performed according to the stringent protocol of Magnusson and Kligman, in which adjuvant is used to elicit an immunologic reaction. The challenge application was executed with Duhring chambers to aim for better, L e. more exaggerated, exposure conditions. The test protocol is in compliance with the OECD Guideline for the Testing of Chemicals No. 406 Skin Sensitisation (1992). The maximum compatible doses for the intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment. In the main experiment ten (10) female guinea pigs of the strain "Pirbright White" were treated intradermally with 0.1 ml of a 3.5 % (w/w) dilution of the test substance in saline. For the dermal induction the undiluted test substance was used. Intradermal application of the 3.5 % (w/w) dilution of the test substance in saline caused slight to moderate erythema and edema formation and the topical application of the undiluted test substance caused slight erythema and edema formation. In the challenge application Duhring chambers with a 30 % (w/w) dilution of the test substance in saline were used, a test concentration which was definitely non-irritating. Besides crust formation at the injection sides after intradermal application with FCA no other systemic toxic symptoms or toxic reactions were observed at any time during the study. Body weight development of the animals was positive and within normal ranges. In the challenge no visible changes on the skin (no erythema and no edema) were observed at any time point; i.e. there was no positive challenge result in the test and the control group animals. Thus, the sensitisation rate was 0 %. Therefore, the test substance Formamidopropyldimethylbetaine has to be regarded as non-sensitising under the applied test conditions when exposed to the skin of experimental animals.
Migrated from Short description of key information:
In the GPMT test with the test substance Formamidopropyldimethylbetaine, the sensitisation rate was 0 %
Justification for selection of skin sensitisation endpoint:
Data from a GLP compliant guideline study with reliability 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
In conclusion, the result of a Magnusson and Kligman study with guinea pigs indicate that Formamidopropyldimethylbetain does not induce skin sensitisation.
According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 Formamidopropyldimethylbetain is not classified as “sensitising” and labelling is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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