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EC number: 224-207-2 | CAS number: 4246-51-9
- 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, rabbit, similar to OECD 404: corrosive (1984, no GLP, reliability 2)
Eye: corrosive
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:
- October 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- short exposure period (3 min and 1 hour); occlusive coverage; short observation period (72 hours); non-GLP)
- Principles of method if other than guideline:
- BASF-test (short-term test): The undiluted test substance was applied 3 min and 1 h to the intact rabbit skin under an occlusive dressing. Scoring according to Draize was carried out after patch removal and after 24, 48 and 72 h.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4,7,10-Trioxatridecan-1,13-diamin
- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Expiration date of the lot/batch: July 1985 - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: mean males 2.69 kg
- Housing: single housing in stainless steel cages (floor area 40 cm x 51 cm)
- Diet: ca. 130 g Ovator Solikanin 4 mm (Muskator-Werke, Düsseldorf, FRG) per animal per day
- Water: ca. 250 mL tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: ca. 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm skin area on the upper third of the back or flank
- Type of wrap if used: not specified
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (concentrated) and Lutrol/water (1:1)
- Time after start of exposure: 3 minutes or 1 hour
SCORING SYSTEM: according to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 3 minutes occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 3 minutes occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 1 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 1 hour occlusive exposure
- Irritant / corrosive response data:
- 3 min exposure: erythema of max. grade 2, not fully reversible within the 72-h observation period; edema of grade 1 in one animal, fully reversible within 48 h
1 h exposure: comprehensive erythema and edema; necrosis in all animals from 24 h after application of the TS onwards, full-thickness necrosis in all animals 72 h after application of the TS, finding macroscopic-pathologically confirmed 72 h after application of the TS - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- A 1-hour occlusive treatment with the unchanged test substanced caused skin corrosion in rabbits.
- Executive summary:
In this short-term test (non-GLP, reliability 2), the undiluted test substance was applied 3 min and 1 h to the intact rabbit skin (3 males, Vienna White) under an occlusive dressing. After exposure, the substance was washed with with Lutrol (concentrated) and Lutrol/water (1:1). Scoring according to Draize was carried out after patch removal and after 24, 48 and 72 h. An exposure duration of 3 min caused erythema of max. grade 2 (not fully reversible) and edema of grade 1 in one animal (fully reversible within 48 h). Extension of the exposure time provoked severe skin reactions. After 1 h of treatment, comprehensive erythema and edema, as well as necrosis was observed in all animals from 24 h after application of the test substance onwards. A full-thickness necrosis in all animals was macroscopic-pathologically confirmed at the end of the study.
Based on this study finding, the test substance is corossive (Cat. 1B) to the skin.
Reference
Table 1: Irritation scores:
Timepoint |
Animal No. |
Intact skin |
Symptoms |
|
Erythema |
Edema |
|||
3 minutes exposure, occlusive |
||||
3 min |
1 |
1 |
0 |
|
2 |
1 |
1 |
|
|
3 |
1 |
0 |
|
|
24 h |
1 |
0 |
0 |
|
2 |
2 |
1 |
|
|
3 |
1 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
2 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
|
2 |
2 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
Mean 24, 48, 72 h |
2 |
2 |
0.3 |
|
Mean 24, 48, 72 h |
3 |
0.3 |
0 |
|
Mean 24, 48, 72 h |
1, 2, 3 |
0.8 |
0.1 |
|
|
||||
1 hour exposure, occlusive |
||||
1 h |
1 |
2 |
3 |
Overlapping erythema and edema, haemorrhagic |
|
2 |
3 |
2 |
|
|
3 |
3 |
3 |
|
24 h |
1 |
4 |
2 |
Necrosis, overlapping edema |
|
2 |
4 |
2 |
|
|
3 |
4 |
2 |
|
48 h |
1 |
4 |
2 |
Necrosis, overlapping edema |
|
2 |
4 |
2 |
|
|
3 |
4 |
2 |
|
72 h |
1 |
4 |
2 |
Necrosis, overlapping edema, full-thickness necrosis macroscopic-pathologically confirmed |
|
2 |
4 |
1 |
|
|
3 |
4 |
2 |
|
Mean 24, 48, 72 h |
1 |
4 |
2 |
|
Mean 24, 48, 72 h |
2 |
4 |
1.7 |
|
Mean 24, 48, 72 h |
3 |
4 |
2 |
|
Mean 24, 48, 72 h |
1, 2, 3 |
4 |
1.9 |
|
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:
The skin irritating/corrosive potential of the test substance was analysed in rabbits in an in-house (short-term) test (BASF, 1984) similar to OECD guideline 404. A 2.5 x 2.5 cm cloth coated with the test substance was applied 3 min and 1 h to the intact rabbit skin under an occlusive dressing. Scoring according to Draize was carried out after patch removal and the severity was noted 24, 48 and 72 h after substance application.
The following observations were made:
3 min exposure: erythema of max. grade 2, not fully reversible within the 72-hour exposure period; edema of grade 1 in one animal, fully reversible within 48 hours. The beginning reversibility of the irritating effects seen at the 72 h reading indicates that no full-thicknesss necrosis would have occurred after a prolonged observation period.
1 hour exposure: comprehensive erythema and edema; necrosis in all animals from 24 hours after application (i.e. of the test substance) onwards, full-thickness necrosis in all animals 72 hours after application, finding macroscopic-pathologically confirmed 72 hours after application.The study is classified as acceptable (key study).
In addition, in a skin irritation study (Union Carbide Corp., 1992) on rabbits it was demonstrated that the test substance exhibited corrosive properties, since full-thickness necrosis was noted after 1-hour dermal exposure to the test substance.
Smyth et al. (1969) reported the test substance as ‘highly irritating’ to rabbit skin. Both references were flagged as ‘supporting study.’
Eye irritation:
Eye injury in rabbits was investigated by Smyth et al. (1969) using a 10-grade ordinal series and was based upon the degree of corneal necrosis that resulted from instillation of various volumes and concentrations of a chemical. Grade 1 indicates at most a very small area of necrosis resulting from 0.5 mL of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 mL, and Grade 10 indicates a severe burn from 0.5 mL of a 1% solution in water or propylene glycol.Corneal injury in rabbits were classified as Grade 8 (= excess of 5 % solution gives injury of up to 5.0 points (15 % gives over 5.0), see Carpenter, C.P. & Smyth, H.F.: Chemical Burns of the Rabbit Cornea.Am. J. Ophthal. 29: 1363 (Nov. 1946)). The test substance was deemed as ‘highly irritating’. This publication is classified as acceptable.
Justification for selection of skin irritation / corrosion
endpoint:
Most reliable study (key study).
Justification for selection of eye irritation endpoint:
Only one study available.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive based on skin corrosivity
Justification for classification or non-classification
In the skin irritation study, the test substance induced necrosis in all tested animals following a 1 hour exposure period. Thus, the substance is considered to be classified for skin corrosion Cat. 1B under Regulation (EC) No. 1272/2008. As the substance is skin corrosive, this leads to its classification as serious eye damage Cat. 1.
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