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EC number: 701-281-9 | 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 17 March 2010 to 18 August 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Propionaldehyde, reaction products with formaldehyde
- EC Number:
- 701-281-9
- Molecular formula:
- C5H10O3
- IUPAC Name:
- Propionaldehyde, reaction products with formaldehyde
- Details on test material:
- - Name of test material: Propionaldehyde, reaction products with formaldehyde (EC 701-281-9) was former registered with identifier 3-Hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde (CAS 18516-18-2)
- Lot/batch No.: CH 138067/001 as cited in report freeze-dried for analytical purpose
- Expiration date of the lot/batch: 30 November 2010
- Stability under test conditions: min. 1 year
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species and strain: Rabbits, New Zealand White.
Supplier: Charles River Deutschland GmbH, D-88353 Kisslegg.
Number and sex: 3 females.
Body weight (at the start and at the termination of the study):
Animal No. 1: 2.1 kg and 2.3 kg.
Animal No. 2: 2.5 kg and 2.5 kg.
Animal No. 3: 2.4 kg and 2.5 kg.
Hygiene: Optimal hygienic conditions.
Room number: EI1-8.
Room temperature: Ranges from 19.32 to 20.83 °C.
Relative humidity: Ranges from 44.05 to 57.72 %.
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in terulan cages, Ehret GmbH, A-3430 Tulln, 65 cm x 65 cm bottom area, 50 cm height.
Feed: Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany.
Water: Tap water from an automatic watering system, ad libitum.
Identification: Labelling with felt-tipped pen on a pinna and cage labels.
Acclimatisation: 7 days (animal No. 1) and 14 days (animal Nos. 2 and 3)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g per animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg.
Hair was clipped on the dorsal areas of the trunks one day before the application of the test substance. An electric hair clipper, Aesculap GH 204 with a 1 mm cutterhead, was used.
The test sites were median on the dorsal thoracal region.
Samples with approximately 0.5 g of the test substance were moistened with 1.0 mL deionised water and were placed on gauze patches1) in a size of about 2.5 cm x 2.5 cm and were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes2). The application sites were covered semi-occlusively by a dressing3).
Access by the animals to the application sites was prevented by a plastic collar.
1) Pur Zellin-Tupfer, obtained by Fa. Hartmann , A-2355 Wiener Neudorf.
2) "Blenderm ®" surgical tape, hypoallergenic, 3M, Medical Products Division, St. Paul, MN 551444, USA.
3) Self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the dressings, the tapes with the patches and the collars were removed.
- Time after start of exposure: The duration of the exposure was 4 hours.
OBSERVATION TIME POINTS
The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia) approximately 1, 24, 48 and 72 hours after patch removal.
No further examinations were performed thereafter.
SCORING SYSTEM:
- The surrounding of the administration area, i.e. the untreated skin, served as a negative control.
The skin was examined using a cold light source KL 1500 electronic.
Dermal irritation was described and recorded according to the scoring scheme for acute dermal irritation/corrosion tests.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All areas treated with the test substance and all control areas were normal before the application.
Erythema/eschar: Not observed at any observation point.
Oedema: Not observed at any observation point. - Other effects:
- None
Any other information on results incl. tables
|
Mean Scores for Animal No.: |
||
|
1 |
2 |
3 |
Erythema / Eschar: |
0.0 |
0.0 |
0.0 |
Oedema: |
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU GHS
- Conclusions:
- Based on the mean scores calculated from the individual examinations performed 24, 48 and 72 h p.a. and referring to Regulation (EC) No 1272/2008 the test substance does not require classification for skin irritation.
- Executive summary:
The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits. Methods and investigations were performed in accordance with the OECD Guideline 404 and the Council Regulation (EC) No 440/2008, Method B.4. and in accordance with GLP requirements.0.5 g test substance, moistened with deionised water, was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing. The duration of the exposure was 4 hours.
First the test substance was administered to one animal. As no serious skin reactions were noted in this animal, the remaining two animals were exposed to the test substance one week later.
Investigations on body weights were performed at the start and at the termination of the test. General signs of toxicity were checked once daily and skin examinations were done 1, 24, 48 and 72 h after patch removal (p.a.).
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Skin examinations
· Erythema/Eschar: Not observed at any observation point.
· Oedema: Not observed at any observation point.
The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:
Mean Scores for Animal No.:
1
2
3
Erythema / Eschar
0.0
0.0
0.0
Oedema
0.0
0.0
0.0
According to Regulation (EC) No 127272008 the test substance does not require classification for skin irritation.
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.
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