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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 931-319-1 | 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to the EU RAR for Sodium Hydroxide (2007; section 4.1.2.3.1), a Klimisch 1 reliability score was assigned since the test procedure is in accordance with generally accepted scientific standards and described in sufficient detail.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of a human patch test for the identification and classification of skin irritation potential
- Author:
- York M, Griffiths E, Whittle E and Basketter DA
- Year:
- 1 996
- Bibliographic source:
- Contact Dermatitis, 34, 204-212
Materials and methods
- Principles of method if other than guideline:
- Treatment sites were assessed for the presence of irritation using a 4 point scale at 24, 48 and 72 hours after patch removal. Sodium dodecyl sulfate (20 %) was used as a positive control and is the minimum concentration classified as "irritating to skin" (R38) under EU regulations.
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Sodium hydroxide (NaOH)
- Other: source is Sherman
Test animals
- Species:
- human
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- HUMAN VOLUNTEERS
- Sex distribution in the individual panels was not standardized
- Age: 18 to 65 years
- Normal healthy volunteers
Test system
- Type of coverage:
- other: patch - 25 mm Hill Top chamber containing a Webril pad (occluded exposure)
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- other: SDS (20%) was used as positive control
- Amount / concentration applied:
- Concentration: 0.5 %
Total volume applied: 0.2 ml - Duration of treatment / exposure:
- To avoid the production of unacceptably high reactions a cautious approach to testing was adopted. Test materials were applied progressively from 15 and 30 min through 1, 2, 3 and 4 h. The 15 and 30 min exposure periods were omitted if the Study Directors were satisfied that excessive reactions would not occur following the 1 h exposure.
- Observation period:
- Examination time points: 24, 48 and 72 hours after patch removal
- Number of animals:
- Number of volunteers: 33
- Details on study design:
- TEST SITE
- Area of exposure: upper outer arm
SCORING SYSTEM: 0 (no reaction)- +++ (strongly positive reaction)
Results and discussion
In vivo
- Irritant / corrosive response data:
- The total number of "positive" reactions was 20 of the 33 subjects after 1 hour, which is higher than SDS (20 %) after 1 hour (4 of 33 subjects) but less than the 4 hour reaction to SDS (23/33).
Any other information on results incl. tables
Existing EU classification | Total reactivity at 4 h (% reactivity) | Comparable 20% SDS reactivity (%) | Classification based on human patch test |
R38 | 20/33 (61)* | 4/33 (12)** | R38 |
20/33 (70)*** |
R38: Irritating to skin
*: maximum exposure 1 h because of strong level of response
**: 1h exposure
***: 4 h exposure
Similar results for sodium hydroxide (0.5%) are reported in the publication of Griffiths et al.(1997) where the patch test procedure of York et al. was used in an interlaboratory test to validate an alternative (in vivo) method to the Draize skin irritation test involving use of human volunteers to identify skin irritation hazard. The study was performed in three different test facilities (Unilever, proDerm and P&G). The Unilever results are summarised in the table above. Following results were obtained from proDerm and P&G:
Test group | Dates | No of (+)ve reactions* | No of (+)ve SDS reactions* | HPT Class§ |
proDerm | Nov/Dec 94 | 13/31 (42)** | 1/31 (3)** | R38 |
22/31 (71) | ||||
P&G | Sep/Oct 95 | 21/34 (62)** | 7/34 (21)** | R38 |
32/34 (94) |
*Results are presented as the proportion of the test panel giving an irritant response, with percentages in parentheses
§EC classification based on the results of the human 4 hr patch test (HPT); the substance is not classified if the proportion of the panel reaching to it is not significantly less than that to the concurrent positive control using the Fisher's exact test
**Results at 1 hour of exposure.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information 0.5% NaOH; for exposure up to 1 hour
- Conclusions:
- NaOH was identified as R38 "Irritating to the skin". The "irritant" classification for NaOH (0.5%) may be an underestimation, based on the intensity of the response in a large proportion of the panel after only 1h of treatment.
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