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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
Endpoint summary
Administrative data
Description of key information
Not irritating according to the CLP
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: US FHSA. 16 CFR 1500.41
- Deviations:
- yes
- Remarks:
- No reading at 48 hours after administration of test material
- Principles of method if other than guideline:
- Procedure used was based on the Draize procedure as required in US FHSA, 16 CFR 1500.41
- GLP compliance:
- not specified
- Remarks:
- predatees establishment of GLP
- 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 Cream colored semisolid
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Six albino rabbits were selected from healthy, acclimated animals.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The back was shaved and the skin was abraded on the right side. The skin remained intact on the left half of the back.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- not specified
- Amount / concentration applied:
- 0.5g was applied to the skin on both halves of the back.
- Duration of treatment / exposure:
- Exposure of the substance occurred for 24 hours and was then removed from the skin. The sites of exposure were observed for 72 hours.
- Observation period:
- Observation occured at 24 and 72 hours after the substance was applied.
- Number of animals:
- Six
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.29
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- Of the animals demonstrating irritation, most showed barely perceptible to very slight erythema or edema. Only one animal, in the portion of the skin which was abraded, showed clearly defined erythema/eschar formation. The overall average of all animals is an irritation score of 1.29, including scores in abraded skin. Concerning readings in intact skin only, only 2 animals displayed erythema (maximal observed value of 1), and only 1 animal displayed edema (max observed value of 1).
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The overall score of 1.29 is below the value of 2.3 or higher in intact skin, as required for classification according to the CLP.
- Conclusions:
- On the basis of the data presented, the substance is mildly irritating to the skin of rabbits. The degree of irritation does not meet the criteria for classification as a skin irritant according to CLP, Regulation EC No. 1272/2008.
Reference
Findings of the study:
Findings |
Exposure Time (Hours) |
Exposure Unit (Value) |
|||||
Rabbit No. |
|||||||
|
1 2 3 4 5 6 |
||||||
Erythema and eschar formation: |
|||||||
Intact Skin |
24 |
1 |
0 |
0 |
0 |
1 |
1 |
Intact Skin |
72 |
0 |
0 |
0 |
0 |
1 |
1 |
Abraded Skin |
24 |
1 |
1 |
1 |
1 |
1 |
1 |
Abraded Skin |
72 |
1 |
1 |
1 |
1 |
2 |
1 |
Subtotal…… |
3 |
2 |
2 |
2 |
5 |
4 |
|
Edema Formation: |
|||||||
Intact Skin |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
Intact Skin |
72 |
0 |
0 |
0 |
0 |
0 |
1 |
Abraded Skin |
24 |
0 |
1 |
1 |
1 |
1 |
1 |
Abraded Skin |
72 |
2 |
1 |
1 |
1 |
1 |
1 |
Subtotal….. |
2 |
2 |
2 |
2 |
2 |
3 |
|
Total………… |
5 |
4 |
4 |
4 |
7 |
7 |
|
Score……….. |
1.25 |
1.00 |
1.00 |
1.00 |
1.75 |
1.75 |
|
Average = 1.29 |
Draize Scoring Criteria:
Primary Skin Irritation Indexes of less than 2.0 are mild irritants.
Primary Skin Irritation Indexes of 2.0 to 5.0 are moderate irritants.
Primary Skin Irritation Indexes of greater than 5.0 are severe irritants.
Findings |
Exposure Time (Hours) |
Exposure Unit (Value) |
|||||
Rabbit No. |
|||||||
|
1 2 3 4 5 6 |
||||||
Erythema and eschar formation: |
|||||||
Intact Skin |
24 |
1 |
0 |
0 |
0 |
1 |
1 |
Intact Skin |
72 |
0 |
0 |
0 |
0 |
1 |
1 |
Abraded Skin |
24 |
1 |
1 |
1 |
1 |
1 |
1 |
Abraded Skin |
72 |
1 |
1 |
1 |
1 |
2 |
1 |
Subtotal…… |
3 |
2 |
2 |
2 |
5 |
4 |
|
Edema Formation: |
|||||||
Intact Skin |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
Intact Skin |
72 |
0 |
0 |
0 |
0 |
0 |
1 |
Abraded Skin |
24 |
0 |
1 |
1 |
1 |
1 |
1 |
Abraded Skin |
72 |
2 |
1 |
1 |
1 |
1 |
1 |
Subtotal….. |
2 |
2 |
2 |
2 |
2 |
3 |
|
Total………… |
5 |
4 |
4 |
4 |
7 |
7 |
|
Score……….. |
1.25 |
1.00 |
1.00 |
1.00 |
1.75 |
1.75 |
|
Average = 1.29 |
Draize Scoring Criteria:
Primary Skin Irritation Indexes of less than 2.0 are mild irritants.
Primary Skin Irritation Indexes of 2.0 to 5.0 are moderate irritants.
Primary Skin Irritation Indexes of greater than 5.0 are severe irritants.
Erythema was observed in the intact skin and abraded skin of three animals, and only in the abraded skin of three additional animals. Erythema in the intact skin of one animal cleared during the 72 -hour observation period. Edema was observed in the intact and abraded skin of one animal, and in the abraded skin of five additional animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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.
- 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.
- 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
- 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The substance displayed mild irritation to skin or eye, which, in either case, did not qualify for classification as irritants according to the ECHA Guidance on the interpretation of the CLP criteria (ver 5.0, 2015). The criteria for classification according to Regulation EC No. 1272/2008 are not met and the substance is not classified.
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