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Diss Factsheets
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EC number: 201-044-5 | CAS number: 77-62-3
- 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:
- March 18 - April 2, 1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD & EU test guidelines in compliance with GLP and reported with a GLP certificate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
- EC Number:
- 201-044-5
- EC Name:
- 2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
- Cas Number:
- 77-62-3
- Molecular formula:
- C29H40O2
- IUPAC Name:
- 2-{[2-hydroxy-5-methyl-3-(1-methylcyclohexyl)phenyl]methyl}-4-methyl-6-(1-methylcyclohexyl)phenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Lowinox PSW
Batch No.: not specified by the sponsor
Chemical name: 2,2’-Dihydroxy- 3,3’-di (α-methylcyclohexyl)-5 ,5’-dimethyl-diphenylmethane (as specified by the sponsor)
Active component: 100% (as specified by the sponsor)
Purity: 98 (as specified by the sponsor)
Physical state: white powder
Identification: labelled, where appropriate, with name of test article, batch no., name of sponsor, project no., date of receipt, storage conditions, handling precautions and expiry date
Storage: ambient
Stability: not specified by sponsor
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: rabbit
Strain: White New Zealand
Source: Harald Schriever; Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
Animal selection: random
Animal identification: with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
Husbandry
Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
Illumination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature: 20 ± 3° C
Relative humidity: 30 - 70 %
Measurement: with thermohygrometer twice daily
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hour
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- Preparation if the animals
24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was examined for abrasions and only animals with healthy, intact skin were used in the test.
Preparation of the test article
The test article was moistened sufficiently with Aqua ad iniectabilia to ensure a good contact with the skin.
Exposure
In each animal, 0.5 g of the test article were applied to the test site (ca. 6 cm2 in size), an adjacent area of untreated skin serving as a control. Each test area was covered with a semi-occlusive dressing consisting of Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), which was held in place by non-irritating tape Elastoplast® (Beiersdorf AG, Hamburg), and Stülpa® (P. Harmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk. At the end of the 4-h exposure period, the dressing was removed and any residual sample was carefully washed off with water or an appropriate solvent.
Observations
Animals were examined for signs of skin reactions at 30-60 min, 24, 48 and 72 h after patch removal. The skin was evaluated according to the scheme presented in table form (see Any other information).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0, 24, 48 & 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0, 24, 48 & 72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No test artcle-dependent findings were observed.
- Other effects:
- No toxic effects were observed.
Any other information on results incl. tables
Individual values of skin reactions
Animal number |
Time after patch removal |
|||||||
30-60 min |
24h |
48h |
72h |
|||||
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
|
|
T C |
T C |
T C |
T C |
T C |
T C |
T C |
T C |
1 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
T = test site
C = control site
Ery = erythema
Oed = oedema
Mean values of skin reactions of 24, 48 and 72h after patch removal
Animal number |
Erythema (test site) |
Oedema (test site) |
1 |
0.0 |
0.0 |
2 |
0.0 |
0.0 |
3 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991. When applied to the skin, the test article "Lowinox PSW" may therefore be considered to be non-irritant.
- Executive summary:
The aim of the test was to assess the irritant and/or corrosive effect(s) of "Lowinox PSW" on the skin. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the skin to the test article.
The test was conducted according to the OECD guideline for the testing of chemicals no. 404 (May 12, 1981) and the EEC directive 84/449/EEC (September 19, 1984). The study was carried out as described in the corresponding protocol approved by the testing facility and the study sponsor on February 12 and 24, 1993, respectively. The principles of Good Laboratory Practice for the testing of chemicals as specified by national (BGB1. I, no. 13, § 19a, March 22, 1990) and international (OECD, Paris, 1982) legislation were followed during the performance of the study.
SUMMARY
The potential toxicity of "Lowinox PSW" was assessed in an acute dermal irritation/corrosion test on 3 albino rabbits. The skin was exposed to the test article for 4 h. Animals were examined for signs of erythema and oedema at 30-60 min, 24, 48 and 72 h after patch removal.
Results
No test article-dependent findings were observed.
The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991. When applied to the skin, the test article "Lowinox PSW" may therefore be considered to be non-irritant.
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