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EC number: 254-400-7 | CAS number: 39290-78-3
- 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:
- December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Information on substance identity and composition is lacking. Batch No. is given, guideline 404 is followed and study is performed according to GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2. If substance identity and composition was reported in study report then reliability would turn into 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- - Age of animals is not mentioned.
- GLP compliance:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- - physical state: colourless liquid
date of receipt: 14.11.95
storage conditions: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no info
- Weight at study initiation: on the day of treatment 2.5 ± 0.3 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: December 12, 1995 To: December 17, 1995
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 ml per animal
- Concentration (if solution): test material was used in its original form
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- - Initial test in 1 animal: one flank 3 minutes; other flank 4 hours
- Confirmatory test in 2 animals: 4 hours - Observation period:
- - 3 days (approximately 1, 24, 48 and 72 hours after patch removal)
- when there is persistent cutaneous irritation after 72 hours the observation period is extended to a maximum of 14 days (until day 15) - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: A single dose of 0.5 ml of the test material was applied to a 6 cm2 gauze pad, which was then applied to the right flank (4 hours in all animals) or the left flank (3 minutes in 1 animal) of the animals. The untreated skin served as control.
- % coverage: no info
- Type of wrap if used: The test material and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test substance was noted at removal of the dressing.
- Time after start of exposure: not applicable
SCORING SYSTEM: see below
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation or corrosion mentioned.
- Other effects:
- No.
Any other information on results incl. tables
Summary of dermal lesions on clipped and intact skin (following 4-h application).
Remark: No cutaneous reactions were observed after an application of three minutes during the initial test in one animal.
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
|
|
|
||
01 |
Erythema/ eschar Oedema |
0
0 |
0
0 |
0
0 |
0
0 |
-
- |
-
- |
|
0
|
0 |
02 |
Erythema/ eschar Oedema |
0
0 |
0
0 |
0
0 |
0
0 |
-
- |
-
- |
|
0 |
0 |
03 |
Erythema/ eschar Oedema |
1
0 |
0
0 |
0
0 |
0
0 |
-
- |
-
- |
|
0 |
0 |
Mean Group |
|
|
|
|
|
|
|
|
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of Aqualenc F was applied on the clipped skin of 3 males New Zealand White rabbits.
An initial test was performed in one animal with exposure periods of 3 minutes and 4 hours. No cutaneous reactions were observed after an application of 3 minutes. A confirmatory is performed in two other animals.
The single 4-hour, semi-occluded application of the test material to the intact skin of all three animals produced immediately after patch removal very slight erythema at the test site of one animal. This effect was gone at 24 hours after patch removal. Necrosis and ulceration were not reported.
The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.
Under the test conditions, test substance is not classified according to the Annex VI of Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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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