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EC number: 931-472-4 | CAS number: 182700-89-6
- 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:
- 6 February to 24 February 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study to GLP conducted using material that consisted of 65 % active ingredient and 35 % xylene.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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:
- Benzoic acid, 2-hydroxy-,C14-18 alkyl derivs.
- EC Number:
- 931-472-4
- Cas Number:
- 182700-89-6
- IUPAC Name:
- Benzoic acid, 2-hydroxy-,C14-18 alkyl derivs.
- Reference substance name:
- 605-976-7
- EC Number:
- 605-976-7
- IUPAC Name:
- 605-976-7
- Test material form:
- liquid: viscous
- Details on test material:
- - Physical state: pale brown viscous liquid
- Stability under test conditions: no data
- Storage condition of test material: under nitrogen at ambient temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 weeks
- Weight at study initiation: 3.01 to 3.29 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 3 to 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22
- Humidity (%): 32 to 57
- Air changes (per hr): 10; no recirculation
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
- Animal No.1: From 6 February 1995 to 21 February 1995
- Animals Nos. 2 and 3: From 9 February 1995 to 24 February 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h and 7, 10, 13 and 16 days after removal of the patch
- Number of animals:
- Three. Initially one animal was tested. As there was no severe irritation, the other two animals were tested.
- Details on study design:
- TEST SITE
- Area of exposure: two sites on each side of the dorsum, one site was treated and the other received an untreated patch.
- % coverage: 3 x 2 cm
- Type of wrap if used: gauze patch, covered in cotton wool and secured with an elasticated bandage held in place with waterproof plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed in warm water and dried with paper tissues
- Time after start of exposure: 4 hr
SCORING SYSTEM: Draize grading system as described in OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Very slight erythema in two animals and well-defined erythema in the third animal was seen at 1 to 72 h after removal of the patch which had disappeared in the former animals by 7 days and in the latter by 10 days. Very slight oedema was observed in one rabbit at 24 and 48 h and in another at 48 and 72 h. Very slight or slight oedema was evident in the third rabbit 1 h after removal of the patch and persisted for 10 days. Loss of elasticity and/or flexibility beginning at 48 h in all animals persisted for up to 13 days. Exfoliation was seen in two rabbits beginning on day 10 (which was still present in one animal on day 13) and in the third rabbit on day 13 (which was still present on day 16) after patch removal.
The control sites showed no responses. - Other effects:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material induced slight (reversible) irritation when 0.5 mL was applied for 4 h to the shaved skin of three rabbits under a semi-occlusive dressing.
- Executive summary:
In a GLP study conducted according to OECD guideline 404/EU Method B.4, the test material (approximately 65 % active substance, 35 % xylene) was assessed for irritant potential when applied to the skin of three New Zealand White rabbits under a semi-occlusive patch for 4 h.
On the day before exposure, the dorsal region between the shoulders was clipped free of hair and examined for irregularities and irritation. The test material (0.5 mL) was applied directly to the skin and covered with a gauze patch held in place with a semi-occluded dressing. After 4 h the patch was removed and the area washed to remove excess test material. The skin was examined for signs of skin irritation at 1, 24, 48 and 72 h and 7, 10, 13 and 16 days after removal of the patch.
Very slight erythema in two animals and well-defined erythema in the third animal was seen 1 to 72 h after removal of the patch, which had disappeared in the former animals by 7 days and in the latter by 10 days. Very slight oedema was observed in one rabbit at 24 and 48 h and in another at 48 and 72 h. Very slight or slight oedema was evident in the third rabbit from 1 h after removal of the patch and persisted for 10 days. Loss of elasticity and flexibility beginning at 48 h in all animals persisted for up to 13 days. Exfoliation was seen in two rabbits beginning on day 10 (which was still present in one animal on day 13) and in the third rabbit on day 13 (which was still present on day 16) after patch removal.
In conclusion, the test material, which contained 35 % xylene (a known irritant) caused slight irritation to the skin of rabbits, though this was not severe enough to warrant classification in accordance with EU criteria.
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