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EC number: - | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Cas Number:
- 139734-65-9
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Details on test material:
- - Name of test material: DOPA-Glycinate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientific des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 14–15 weeks (male), 12–13 weeks (females)
- Weight at study initiation: 2229 – 2309 g
- Housing: individually
- Diet: pelleted diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (lyophilised test substance) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 16 cm² (4.0 cm x 4.0 cm) on a flank
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: score of this animal was not assessable after 48 and 72 hours due to deep necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: not expected to be reversible
- Remarks on result:
- other: this animal was killed for ethical reasons after the 72-hour reading due to the deep necrosis observed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: scaling was observed on days 7 and 10 (reversible within 14 d)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- One hour after patch removal slight erythema, well-defined erythema, severe erythema were observed in all animals and slight swelling edema and moderate swelling edema were observed in two animals. After 24 hours one animal showed no erythema and no edema. The well-defined erythema persisted until 72 hours, decreased to slight erythema 7 days after patch removal and was gone on day 14. In animal no.9 the edema decreased from slight swelling after 24 hours to very slight swelling after 48 hours and 7 days after patch removal the edema was gone. The severe erythema of animal no.7 persisted until 24 hour reading; it was noted with dry skin from the 24- to the 72-hour reading and was not assessable due to deep necrosis at 48 and 72 hour evaluation. The edema decreased from moderate swelling after 24 hours to slight swelling after 48 hours and very slight swelling after 72 hours, then animal no. 7 was killed for ethical reasons.
The cutaneous reactions were reversible in one animal after 24 hours, in another animal within 14 days after removal of the patch. The third animal was sacrificed after the 72 hour reading for ethical reasons.
No staining produced by the test item of the treated skin was observed. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study. One animal was sacrificed for ethical reasons after the 72-hour reading.
In one animal (no.9) on day 7 and day 10 scaling was present.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
animal |
observation |
erythema |
edema |
scaling |
#1 #2 #3 |
1 h |
4 1 2 |
3 0 2 |
0 0 0 |
#1 #2 #3 |
24 h |
4 0 2 |
3 0 2 |
0 0 0 |
#1 #2 #3 |
48 h |
n.a. 0 2 |
2 0 1 |
0 0 0 |
#1 #2 #3 |
72 h |
n.a. 0 2 |
1 0 1 |
0 0 0 |
#1 #2 #3 |
7 d |
-** 0 1 |
-** 0 0 |
-** 0 x |
#1 #2 #3 |
10 d |
-** 0 1 |
-** 0 0 |
-** 0 x |
#1 #2 #3 |
14 d |
-** 0 0 |
-** 0 0 |
-** 0 0 |
n.a. : score of this animal was not assessable after 48 and 72 hours due to deep necrosis
-**: this animal was killed for ethical reasons after the 72-hour reading due to the deep necrosis observed
x: scaling present
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- In this skin irritation test in rabbit, the registration substance caused full thickness destruction of the skin tissue at the application site in one animal. Thus, the test substance has to be classified as corrosive Category 1C according to the criteria laid down in Regulation (EC) No 1272/2008 as well as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.
- Executive summary:
The acute dermal irritation of the registration substance (lyophilised, 99.4% a.i.) was tested in 3 New Zealand white rabbits, according to EC method B.4 (2004/73/EEC) and OECD guideline 404 (2002).Rabbits were applied a dose of 0.5 g on the shaved intact skin for a period of 4 hours (semi-occlusive).
The application of the test item to the skin resulted in mild to severe and early-onset signs of irritation such as erythema, oedema and scaling. These effects were reversible and were no longer evident in the two surviving animals 14 days after treatment, the end of the observation period for all animals. One animal was noted with dry skin from the 24- to the 72-hour reading as well as with deep necrosis (full thickness destruction of the skin tissue) at the 48- and 72-hour reading. Thereafter, it was sacrificed for ethical reasons.
According to the requirements specified by Regulation (EC) 1272/2008 and subsequent regulations, the registration substance requires classification for skin corrosion/irritation with classification category 1C, signal word “danger” and the hazard phrase “H314: Causes severe skin burns and eye damage” according to the classification criteria of Regulation 1272/2008.
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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