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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-696-3 | CAS number: 78605-96-6
- 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
- Study period:
- 11 October 1993 to 22 November 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline line compliant, GLP study conducted at reputable laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Heptanal, 2-(phenylmethylene)-, (2E)-
- EC Number:
- 800-696-3
- Cas Number:
- 78605-96-6
- Molecular formula:
- C14 H18 O
- IUPAC Name:
- Heptanal, 2-(phenylmethylene)-, (2E)-
- Details on test material:
- The test material typically contains >94% of the trans (E) isomer and 4-5% of the cis (Z) isomer.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 13-15 weeks old
- Weight at study initiation: 3.1 to 3.5 kg
- Housing: individually in plastic cages with perforated flooring
- Diet (e.g. ad libitum): SDDS Stanrab (P) Rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum access to tap water
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 October 1993 To: 23 October 1993
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL to one intact site per rabbit
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 13 days after application of test material
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 25 x 25 mm
- Type of wrap if used: gauze pad covered by elastoplast elastic adhesive tape to provide semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and blotting dry
- Time after start of exposure: 4 hours
SCORING SYSTEM: Standard Draize assessment. Rabbit skin was assessed approximately 60 minutes after removal of the treatment dressing and then on Days 2, 3, 4 (24, 48 and 72 hour assessments) and daily from day 5 to 13.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Remarks on result:
- other: Generally moderate erythema persisted from Day 1 to day 6 in all three rabbits, ameliorating subsequently and overtly resolved by Day 9 or 13.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9-11 days
- Irritant / corrosive response data:
- All three rabbits developed well-defined erythema and slight oedema that persisted from the initial assessment to Day 6 (moderate oedema was recorded on a single occasion for one rabbit, Day 4, but the response was atypical). Slight or very slight reactions persisted with evidence of desquamation over the following week and all reactions had resolved by Day 9 (one rabbit) or Day 13 (two rabbits).
The overall response with means of 2.0 or greater for both erythema and oedema indicated potential for skin irritancy.
Any other information on results incl. tables
Irritation scores (individual animals)
|
1h |
24h |
48h |
72h |
Mean (24-72h) |
4d |
5d |
6d |
7d |
8d |
9d |
10d |
11d |
12d |
13d |
Erythema |
2,2,2 |
2,2,2 |
2,2,2 |
2,2,2 |
2.00 |
2,2,2 |
2,2,2 |
2,2,2 |
1,2,2 |
1,2,2 |
0,2,2 |
1,1 |
1,1 |
1,1 |
0,0 |
Oedema |
2,2,2 |
2,2,2 |
2,2,2 |
2,2,2 |
2.00 |
2,2,2 |
2,2,2 |
2,2,2 |
1,1,1 |
1,1,1 |
0,1,1 |
1,1 |
0,0 |
0,0 |
0,0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of this study indicate skin irritation but are not sufficient to trigger classification for skin irritation according to the CLP Regulation.
- Executive summary:
In a standard three rabbit assessment of dermal irritation, following 4 hour exposure of intact skin under semi-occluded conditions, slight to well-defined oedema and erythema were observed in all three rabbits, reactions persisted for up to 12 days after application but reversibility was confirmed by Day 13. The results of this study do not trigger classification for skin irritation according to the CLP Regulation.
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.