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EC number: 443-860-6 | CAS number: 302776-68-7
- 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:
- 2003-01-20 until 2003-01-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideine of 12 Nan No. 8147 as this is in line with QECD 404.
- Principles of method if other than guideline:
- None.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 443-860-6
- EC Name:
- -
- Cas Number:
- 302776-68-7
- Molecular formula:
- C24 H31 N O4
- IUPAC Name:
- hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 9 months
- Sex: males and/or females
- Weight at study initiation: 3.95 - 3.98 kg
- Housing: Single housing in stainless steel wire mesh cages with grating (floor area 3000 cm2)
-The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system ensured a temperature in the range of 20- 24°C and a relative humidity in the range of 30 - 70%.
- Diet: Kliba-Labordiät, Provimi Kuba SA, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
- Photoperiod (hrs dark / hrs light): 12 h light (6.00 a.m. - 6.00 p.m.)
12 h darkness (6.00 p.m. - 6.00 a.m.)
IN-LIFE DATES: From: 2003-01-20 To: 2003-01-27
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One side of the back or flank of each animal was left untreated.
- Amount / concentration applied:
- TEST MATERIAL
The test patch (2.5 cm x 2.5 cm) was applied with an undiluted dose of 0.5 mL of the test substance (moistened with water, at about 60°C, but cooled down to body temperature before it was applied).
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 7 days after removal of the patch
- Number of animals:
- 3 rabbits.
- Details on study design:
- TEST SITE
The liquid test substance was applied undiluted in a single dose to the intact untreated skin through a patch. The test patch (2.5 cm x 2.5 cm) was applied to the flank of each animal and secured in position with a semiocclusive dressing. Because the test substance is applied undiluted or minimally moistened with doubly-distilled water, no analysis of the test substance in a vehicle was necessary.
REMOVAL OF TEST SUBSTANCE
The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1).
SCORING SYSTEM: Evaluation of skin reactions (erythema and edema) is performed according to the quoted guidelines.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Remains of the TS still present after removal (4 hours).
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Remains of the TS still present after removal (4 hours). Pulling out of hair due to adhesive properties of the TS.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Remains of the TS still present after removal (4 hours).
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corrosive effects were observed.
Moderate/severe erythema (grade 2-3), observed 1 hour after removal of the patch in all animals, persisted up to 24 hours and decreased to slight erythema (grade 1) at the 48- and 72-hour reading. Moreover, remains of test substance was found on the skin of all animals during the observation period. In one animal mechanically pulled out hair due to adhesive test substance was recorded at the beginning of the study.
The cutaneous reactions were reversible in all animals within 7 days after removal of the patch.
Mean scores over 24, 48 and 72 hours for each animal and overall mean was 1.3 for erythema and 0.0 for edema - Other effects:
- No other effects.
Any other information on results incl. tables
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
1 h |
01 |
2 |
0 |
RT |
02 |
2 |
0 |
RT, 26 |
|
03 |
3 |
0 |
RT |
|
24 h |
01 |
2 |
0 |
RT |
02 |
2 |
0 |
RT, 26 |
|
03 |
2 |
0 |
RT |
|
48 h |
01 |
1 |
0 |
RT |
02 |
1 |
0 |
RT |
|
03 |
1 |
0 |
RT |
|
72 h |
01 |
1 |
0 |
|
02 |
1 |
0 |
RT |
|
03 |
1 |
0 |
|
|
7 d |
01 |
0 |
0 |
|
02 |
0 |
0 |
RT |
|
03 |
0 |
0 |
|
|
Mean |
01 |
1.3 |
0.0 |
|
02 |
1.3 |
0.0 |
|
|
03 |
1.3 |
0.0 |
|
|
Mean |
- |
1.3 |
0.0 |
|
RT = Remains of test substance
26 = Mechanically pulled out hair due to adhesive test substance
Though results and evaluation indicate that the test substance has a slight irritation potential, it should be taken in account that the cutaneous reactions might be a secondary effect, related to a prolonged exposure period due to rests of test substance.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- According to the conditions of the test, the test substance has not to be classified as irritating to the skin following EU and the GHS requirements.
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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