Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-130-2 | CAS number: 68003-46-3
- 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
Skin irritation (OECD 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: severe eye damage
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-10-25 to 2004-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 4166310
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature - Species:
- rabbit
- Strain:
- other: Albino rabbits (Chbb:HM)
- Details on test animals or test system and environmental conditions:
- TEST animals:
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight of study initiation: 2500 - 2600 g
- Housing: the rabbits (females) were caged individually in polyphenyl ether (PPE) cages with perforated floor.
- Diet: pelleted complete diet Altromin 2123 (Altromin GmbH, Lage, Germany), ad libitum
- Water: (tap/filtered) water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark/hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated site of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h - Observation period:
- Initial test: 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Confirmatory test: 14 days
Reading time points: 1, 24, 48 and 72 h and 7 and 14 days - Number of animals:
- initial test: 1 female
confirmatory test: 2 females - Details on study design:
- TEST SIDE:
- Area of exposure: 6,25 cm² on the right side of the back
- Type of wrap: The treated skin was covered with adhesive Gothaplast tape (2,5 cm)
REMOVAL OF TEST SUBSTANCE:
- Washing: Residual test material was removed with mild soap and lukewarm water.
- Time after start of exposure: initial test: 3 min, 1 and 4 h: confirmatory test: 4 h
SCORING SYSTEM:
Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- - Animal #1 showed a well-defined erythema on the posterior right test field immediately after the application.
- 1 h after termination of exposure a well-defined erythema was observed on the posterior right test field of animal #1. Animal #2 and #3 showed a very slight erythema on the anterior left test fields.
-24 h, 48 h and 72 h after the termination of exposure a well-defined erythema was observed on the posterior right test field of animal #1. Animals #2 and #3 showed a well-defined erythema on the anterior left test field.
- 7 days after the termination of the exposure isolated scales were still observed on the anterior left test field of animal #2 and #3. Animal #1 showed no skin reactions.
- 14 days after the termination of exposure animals #2 and #3 were free of any signs of skin irritation, too. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-11-08 to 2004-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 4166310
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature - Species:
- rabbit
- Strain:
- other: Albino rabbit (Chbb:HM)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: 104 weeks
- Weight at study initiation: 2700 g
- Housing: individual female rabbit was caged in a polyphenyl ether (PPE) cage
- Diet: pelleted complete diet Altromin 2123 (Altromin GmbH, Lage, Germany), ad libitum
- Water: (tap/filtered) water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- water
- Controls:
- other: The untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days - Number of animals or in vitro replicates:
- 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
- Washing: The treated eye was rinsed with 40 mL 0.9% saline solution
- Time after start of exposure: 1 h
SCORING SYSTEM:
- Draize scoring system
TOOL USED TO ASSESS SCORE:
- fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: eye has been washed 1 h p.a. due to severe immediate effects
- Irritant / corrosive response data:
- - The treated eye showed severe irritating/corrosive effects already 1 h after treatment with the test item. Therefore, the test item was washed out with 40 mL of 0.9% saline solution.
- Cornea, iris, conjunctivae and chemosis score were determined 1, 24, 48 and 72 h and 7, 14 and 21 days after removal of the test item.
- the eye irritating/corrosive effects were fully reversible within 21 days - Interpretation of results:
- other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Reference
Table 1: Summary of eye irritation scores
Animal-No./weight in kg |
Irritation parameter |
1 h |
24 h |
48 h |
72 h |
Mean |
7 days |
14 days |
21 days |
1 / 2,7 |
Cornea score (degree)
Cornea score (area) |
3
4 |
2
4 |
2
4 |
2
4 |
2
4 |
1
3 |
0
0
|
0
0 |
Iris score |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
|
Conjunctivae score |
3 |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
|
Chemosis score |
3 |
3 |
1 |
1 |
1,67 |
0 |
0 |
0 |
Remark: Only time points 24, 48 and 72 h were used for calculation of mean value.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In the reliable skin irritation study performed according to OECD TG 404 and in compliance with GLP three female SPF albino rabbits were exposed to 0.5 mL Ammonium lauroyl sarcosinate (CAS 68003-46-3) onto the clipped skin for 3 min, 1 and 4 h under semi-occlusive coverage (Frey-Tox, 2004b). Skin reactions were evaluated according to the Draize scoring system 1, 24, 48 and 72 h and 7 days post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. All tested animals showed well-defined erythema (grade 2) 24 to 72 hours post-administration. Edema formation was not observed during the study period. All skin reactions were fully reversible within the 14-day observation period. Based on the study results and according to EU classification criteria, the test substance is not considered to be irritating to the skin.
Eye irritation
In the reliable eye irritation study with Ammonium lauroyl sarcosinate (CAS 68003-46-3) performed according to OECD TG 405 (Frey-Tox, 2004c) 0.1 mL of the test substance was instilled in the eye of one female Albino rabbit. The exposure period was 1 h, only, due to severe reactions of the animal. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours and 7, 14 and up to 21 days post application. Within 24 to 72 hours post-application mean values of corneal opacity (grade 1.33), redness (grade 2), chemosis (grade 1.67) and light sensitivity of the iris (grade 1) were calculated. All observed effects were fully reversible within 21 days. In spite of the irritant and corrosive effects 1 h post administration no further experiments on additional animals were performed. Based on the study results and according to EU classification criteria, the test substance is considered to cause severe damages to the eye.
Justification for classification or non-classification
The available data on skin irritation / corrosion of Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). The available data on eye irritation, however, meet the criteria for classification for Eye Damage 1 (H318) according to Regulation (EC) No. 1272/2008 (CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.