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EC number: 270-156-4 | CAS number: 68411-97-2
- 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: corrosive
Eye irritation (in vitro and in vivo): Data waiving
As the registered substance is classified for its skin corrosion properties as Skin Corr. 1B (H314), no eye irritation studies have to be conducted according to Regulation (EC) No. 1907/2006 (REACH), Annexes VII and VIII, Item 8.2, Column 2.
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:
- 2004-09-21 to 2004-10-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: SPF albino rabbit of the stock Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Age at study initiation: 56 weeks
- Weight at study initiation: 2400 g
- Housing: individual female rabbit was caged in a polyphenyl ether (PPE) cage
- Diet: pelleted Altromin 2123, Lage, Lippe, ad libitum
- Water: (tap/filtered) water, 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 - 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:
- 0,5 mL
- Duration of treatment / exposure:
- Initial test: 3 min and 1 h
- Observation period:
- Initial test: 28 days
Reading time points: 1, 24, 48, 72 h and 7, 14, 21 and 28 days - Number of animals:
- 1 female
- 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: 3 min, 1h
SCORING SYSTEM:
Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 28 days
- Remarks on result:
- other: skin has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 28 days
- Remarks on result:
- other: skin has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 28 days
- Remarks on result:
- other: skin has been washed 1 h p.a. due to severe immediate effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 28 days
- Remarks on result:
- other: skin has been washed 1 h p.a. due to severe immediate effects
- Irritant / corrosive response data:
- - The animal showed a very slight erythema on the middle and posterior right test field immediately after the application, 1h and 24 h after the termination of exposure a severe erythema to eschar formation and a moderate oedema was observed in the middle right test field as well as a severe erythema to eschar formation and a slight oedema on the posterior right test field.
- 48 h after the termination of exposure the animal showed a severe erythema to eschar formation as red-brownish discoloration and a severe oedema reaching widely beyond the patch area of the middle and posterior right test field.
- 72 h after the termination of exposure a severe erythema to eschar formation and a severe oedema were observed on the middle and posterior right test field of the animal.
- 7 days after the termination of exposure the animal showed a markedly elevated, brownish crust of scales being partially dropped off on the whole area of the middle and posterior right test field.
- 14 days after the termination of exposure granulation tissue was observed underneath the dropped off crust of scales on the middle and posterior right test field.
- 21 days after the termination of exposure the affected skin areas of the middle and posterior test field of the animal were healed almost completely.
- 28 days after the termination of exposure no pathological changes were macroscopically discernible anymore at the animal - Interpretation of results:
- other: Skin corr. 1B, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-12-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- human
- Strain:
- other: human-derived epidermal keratinocytes (EPI-200)
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: MatTek Corporation, MA, USA
TEST METHOD
The model represents a reconstructed three-dimensional skin model based on normal human-derived epidermal keratinocytes which have been cultured to form a multilayered epidermis including basal, spinous and granular layers, and a multi-layered stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTATION TO CELL CULTURE CONDITIONS
Upon receipt, tissues were pre-incubated in assay medium for 1 h (37 °C, 5% CO2) before use. After a medium exchange an amount of 50 µL per insert of the test and reference items were applied onto the surface of the skin models so that they were covered completely. The incubation times were 3 min and 1 h.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37
- CO2 gas concentration (%): 5
- Humidity: maximum - Type of coverage:
- other: open in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- water
- Controls:
- other: concurrent control tissues treated with the vehicle served as negative controls, positive controls were exposed to 8N KOH
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration (if solution): 100%
VEHICLE
- Amount(s) applied: 50 µL
- Lot/batch no: 0274
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: KOH, 8N
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- 3 min and 1 h
- Observation period:
- Not applicable
- Number of animals:
- The test was performed in duplicates for each test or control group and treatment period (3 and 60 min).
- Details on study design:
- TEST SITE
- Area of exposure: 0.6 cm²
REMOVAL OF TEST SUBSTANCE
- The test item was gently rinsed off from the skin models and the tissues were incubated in MTT solution.
- Time after start of exposure: 3 and 60 min
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed. Therefore, tissues were incubated in pre-warmed MTT solution for 3 h at 37 °C and 5% CO2. After aspiration of the MTT solution, tissues were washed 3 times in phosphate buffered saline followed by tissue drying. Extraction of the formazan product was carried out in isopropanol. The optical density was measured at 570 nm wave length in a plate spectrophotometer. - Irritation / corrosion parameter:
- other: cell viability (%)
- Run / experiment:
- 3 min
- Value:
- 100
- Remarks on result:
- other: Basis: mean value of negative controls (distilled water)
- Irritation / corrosion parameter:
- other: cell viability (% of negative control)
- Run / experiment:
- 3 min
- Value:
- 24
- Remarks on result:
- other: Basis: mean value of positive controls (8 N KOH)
- Irritation / corrosion parameter:
- other: cell viability (% of negative control)
- Run / experiment:
- 3 min
- Value:
- 36
- Remarks on result:
- other: Basis: mean value of the test item
- Irritation / corrosion parameter:
- other: cell viability (%)
- Run / experiment:
- 1 h
- Value:
- 100
- Remarks on result:
- other: Basis: mean value of negative controls (distilled water)
- Irritation / corrosion parameter:
- other: cell viability (% of negative control)
- Run / experiment:
- 1 h
- Value:
- 12
- Remarks on result:
- other: Basis: mean value of positive controls (8 N KOH)
- Irritation / corrosion parameter:
- other: cell viability (% of negative control)
- Run / experiment:
- 1 h
- Value:
- 6
- Remarks on result:
- other: Basis: mean value of the test item
- Other effects / acceptance of results:
- In comparison to the untreated control (NC) for the test item there was measured a cell viability of 35 percent and 6 percent after a 3 min and 1 h application, respectively. Based on the results of the study the test item should be classified as corrosive.
- Interpretation of results:
- other: Skin corr. 1, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Referenceopen allclose all
Individual erythema and oedema scores
Animal No./ weight in kg |
Exposure |
Test field |
Erythema formation |
Oedema formation |
|||||||||
0 |
1 |
24 |
48 |
72 |
0 |
1 |
24 |
48 |
72 |
||||
1 / 2,4 |
3 min
|
anterior ri. |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1 h |
median ri. |
1 |
4 |
4 |
4 |
4 |
0 |
3 |
3 |
4a) |
4 |
||
Instead of 4 h, stop after approx.. 1 h |
posterior ri. |
1 |
4 |
4 |
4 |
4 |
0 |
2 |
2 |
4a) |
4 |
Remark 4a): Red-brownish discoloration of the patch area and oedema reaching beyond the patch area widely
Table 1: OD values (570 nm) measured for each test sample
Exposure time |
Test substances |
Tissue |
Optical density (OD) |
Cell viability % untreated control |
||||
Value 1 |
Value 2 |
Value 3 |
Mean |
Mean Tissue 1+2 |
||||
3 min |
Negative control (NC) = distilled water |
1 |
2.007 |
1.993 |
2.010 |
2.003 |
2.031 |
100 |
2 |
2,067 |
2,022 |
2,074 |
2,058 |
||||
PERLASTAN C
|
1 |
0.637 |
0.617 |
0.627 |
0.627 |
0.731 |
36
|
|
2 |
0.852 |
0.822 |
0.833 |
0.836 |
||||
Positive control (PC) = 8 N KOH |
1 |
0.545 |
0.527 |
0.533 |
0.535 |
0.485 |
24 |
|
2 |
0.438 |
0.431 |
0.436 |
0.435 |
||||
1 h |
Negative control (NC) = distilled water |
1 |
1.841 |
1.848 |
1.853 |
1.847 |
1.755 |
100 |
2 |
1.687 |
1.640 |
1.658 |
1.662 |
||||
PERLASTAN C
|
1 |
0.127 |
0.123 |
0.121 |
0.124 |
0.112 |
6 |
|
2 |
0.104 |
0.097 |
0.098 |
0.100 |
||||
Positive control (PC) = 8 N KOH |
1 |
0.168 |
0.163 |
0.191 |
0.174 |
0.213 |
12 |
|
2 |
0.251 |
0.250 |
0.252 |
0.251 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Two studies addressing the skin irritation/corrosion potential are available with the registered substance Glycine, N-methyl-, N-coco acyl derivs (CAS 68411-97-2).
In the reliable skin irritation study performed according to OECD TG 404 and in compliance with GLP one female Albino rabbit was exposed to 0.5 mL of undiluted test substance onto the clipped skin for 3 and 60 min via semi-occlusive dressing (Frey-Tox, 2004). Skin reactions were evaluated according to the Draize scoring system 1, 24, 48, 72 h and 7, 14, 21 and 28 days post-application. Since only a slight erythema was observed immediately after 60 min post application, the 4 h exposure was started. One hour post application the animal showed severe erythema (grade 4) and edema (grade 2) formation, in order that the 4 h exposure was immediately terminated and a confirmatory test was precluded. 24 to 72 hours post application severe erythema (grade 4) and edema (grade 4) were still observed. Thus, mean erythema and edema scores over 24, 48 and 72 h of 4 and 3 were calculated, respectively. In spite of the reduced exposure of 1 h time and severe skin reactions the observation period was extended up to 28 days. Within this period severe skin reactions could be revealed and no pathological changes were discernible anymore. Based on the study results and according to EU classification criteria, the test substance is classified as corrosive to the skin.
In a further study, the in vitro skin corrosion properties of Glycine, N-methyl-, N-coco acyl derivatives (CAS 68411-97-2) were tested in a study performed according to OECD TG 431 under GLP conditions using the EpiDermTM, reconstructed three-dimensional human epidermis (EPI-200) model (Frei-Tox, 2005). In the study, the tissues were treated with the neat test material for exposure periods of 3 and 60 min. Positive and negative controls were included in the study. The corrosive potential of the test material was predicted from the relative mean tissue viabilities compared to the mean viability of the negative control tissues. The positive and negative control substance gave the expected results. The relative mean tissue viabilities of the test compound were 36% after 3 min and 6% after 1 h. Thus, in the described test Glycine, N-methyl-, N-coco acyl derivatives (CAS 68411-97-2) is considered to be corrosive to the skin.
Taken together, the available data on the registered substance indicate that Glycine, N-methyl-, N-coco acyl derivatives (CAS 68411-97-2) is corrosive to the skin.
Eye irritation
Regulation (EC) No. 1907/2006 (REACH) stipulates in its Annexes VII and VIII that tests for eye irritation / severe eye damage do not need to be conducted if the registered substance is classified as skin corrosion. Since Glycine, N-methyl-, N-coco acyl derivs (CAS 68411-97-2) is classified as Skin Corr. 1B as a result of adequate in vitro and in vivo data, testing for eye irritation / severe eye damage is deemed not suitable and necessary. As a result of the skin corrosion properties, contact by any route of exposure to the substance must be avoided and effects of the substance on eyes are avoided as well.
Justification for classification or non-classification
The available data on skin irritation / corrosion of Glycine, N-methyl-, N-coco acyl derivs (CAS 68411-97-2) meet the criteria for classification as Skin Corr. 1B (H314) according to Regulation (EC) No. 1272/2008 (CLP).
No data on eye irritation / severe eye damage are available. Studies addressing the eye irritation / severe eye damage potential are not required due to the classification of the registered substance as skin corrosive (Skin Corr. 1B). In consequence, classification of Glycine, N-methyl-, N-coco acyl derivs (CAS 68411-97-2) as Eye Damage 1 (H318) is implicit.
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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