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EC number: 215-355-9 | CAS number: 1323-42-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Experimental studies were performed in a laboratory prior to establishment of international guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US FHSA, 16 CFR 1500.42
- Principles of method if other than guideline:
- This study was performed according to the procedure described in the US FHSA regulation, in 16 CFR 1500.42. This utilizes 6 animals with evaluation according to the Draize Scale.
- GLP compliance:
- not specified
Test material
- Test material form:
- solid
- Details on test material:
- Physical state/Appearance: Off-white solid
Batch: 0000149116
Purity: >80%
Expiry Date: 28 October 2017
Storage Conditions: Room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- Substance Name: GMHS, Glyceryl Monohydroxystearate, CAS#: 1323-42-8, EC#: 215-355-9, IUPAC: 2-hydroxy-1-(hydroxymethyl)ethyl 2-hydroxyoctadecanoate. The substance used in the test study was a cream colored semi-solid.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- The study was determined on six young adult albino rabbits selected from healthy, acclimated animals.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The standard for the Draize study is 0.1g.
- Duration of treatment / exposure:
- Ocular reactions of the substance was observed and recorded at 24, 48, and 72 hours, and again at 7 days after the instillation of the test material.
- Observation period (in vivo):
- The observation period of the test material occured over 7 days.
- Number of animals or in vitro replicates:
- 6 young adult albino rabbits were used.
- Details on study design:
- Study design was based on the Draize method
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 Days
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The substance showed a mean scorefor conjunctiva of 1.3 out of 110. There was no evidence of corneal opacity or iritis. No conjunctival erythema score was greater than 2. Out of the six rabbits tested, four showed conjunctival erythema at 24 hours, two at 48 hours and 1 at 72 hours. The effects fully cleared by the end of the 7 day observation period.
Any other information on results incl. tables
Findings of the study:
Rabbit No. & Sex |
Item |
Tissue |
24 Hours |
48 Hours |
72 Hours |
7 days |
1 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
|
(1) Cornea Total = (AxB) x 5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
|
(3) Conjunctive Tota l= (D+E+F) x 2 |
2 |
0 |
0 |
0 |
|
|
Totals Added = (1+2+3) |
2 |
0 |
0 |
0 |
|
2 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
|
(1) Cornea Tota l= (AxB) x 5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
1 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
|
(3) Conjunctive Total = (D+E+F) x 2 |
2 |
2 |
0 |
0 |
|
|
Totals Added = (1+2+3) |
2 |
2 |
0 |
0 |
|
3 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
|
(1) Cornea Total = (AxB) x 5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
|
(3) Conjunctive Total = (D+E+F) x 2 |
0 |
0 |
0 |
0 |
|
|
Totals Added = (1+2+3) |
0 |
0 |
0 |
0 |
4 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
|
(1) Cornea Total = (AxB) x 5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
|
(2) Iris Total= (C) x 5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
|
(3) Conjunctive Total = (D+E+F) x 2 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
|
5 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
|
(1) Cornea Total = (AxB) x 5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
1 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
|
(3) Conjunctive Total = (D+E+F) x 2 |
2 |
2 |
0 |
0 |
|
|
Totals Added = (1+2+3) |
2 |
2 |
0 |
0 |
|
6 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
|
(1) Cornea Total = (AxB) x 5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
1 |
1 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
|
(3) Conjunctive Total = (D+E+F) x 2 |
2 |
2 |
2 |
0 |
|
|
Totals Added = (1+2+3) |
2 |
2 |
2 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Conjunctival erythema scores are less than 2.0; corneal and iris effects were not observed
- Conclusions:
- The substance is not irritating to the eyes of rabbits.
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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