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EC number: 700-757-3 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 October 2001 to 18 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- GLYPHO
- IUPAC Name:
- GLYPHO
- Details on test material:
- - Name of test material (as cited in study report:GLYPHO
- Substance type:Yellowish liquid
- Physical state:Liquid
- Lot/batch no.:AH2/170
- Expiration date of the lot/batch:01 February 2002
- Storage condition of test material:In the original container, in the refrigerator, away from direct sunlight.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne/ France
- Age at study initiation:16-17 weeks (male), 14-16 weeks (females)
- Housing: Individually
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%):30-70
- Air changes (per hr):10-15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 08 Oct 2001 To: 18 Oct 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): NEAT - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: Flanks, 6 square cm
- Type of wrap if used: Semi occlusive dressing anchored with tape
SCORING SYSTEM:Erythema 0-4/Oedema 0-4
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Skin Irritation Score
- Basis:
- other: Mean scores for irration and oedema
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0 - ca. 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: No abnormal findings were observed at the test site of any animal 72 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EEC Commission Directive 93/21/EEC of April 27, 1993
- Conclusions:
- Based on the results of the study, the test article is a mild dermal irritant.
- Executive summary:
The primary skin irritation potential of the test article was evaluated in New Zealand White rabbits. This study was performed in accordance with Swiss GLP (2000) and OECD GLP (1997). The study design was based on the following guidelines: OECD 404 (1992) and Directive 92/69 EEC, B.4 (1992). Only 1 female rabbit was initially tested as the test article was suspected to produce irritancy. At a concentration of 10% of the test article in purified water, the pH was found to be 1.72. The hair was clipped from the dorsal skin of the rabbit. The test material (0.5 mL) was placed on a 2.5 x 2.5 cm gauze patch and was applied to the intact skin of the clipped area. The torso was wrapped with a dressing in a semi-occlusive manner and secured with non-irritating tape. Three patches were applied to three different intact sites for a 3 minute, 1 hour, or 4 hour exposure, respectively. Since no severe irritation was observed, a test article patch was placed on each of the remaining 2 animals (1 male, 1 female) following the aforementioned protocol, for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 24, 48 and 72 hours. Skin observations were also recorded at 7 days for the first treated female. The skin irritation score was calculated. Following the 3 minute and 1 hour applications, erythema (score: 1) was observed immediately after unwrapping and at 1 hour postdose but cleared by 24 hours postdose. No edema was observed following 3 minute and 1 hour exposures. At 1, 24, and 48 hours post 4 hour exposures, erythema (scores: 2, 2, 1, respectively) and edema (scores: 2, 2, 0, respectively) were observed in the initially treated female. All skin reaction scores for the other animals were 0 throughout the study. The individual mean scores (24-72 hours) for erythema were 0.0, 1.0, and 0.0. The individual mean scores (24-72 hours) for edema were 0.0, 0.67, and 0.0. The PII was 0.56/8.0. Based on the results of this study, the test article is a mild dermal irritant.
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