Registration Dossier
Registration Dossier
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EC number: 615-244-9 | CAS number: 71035-05-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Basic information given
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: US Reg. (21 CFR 191.11)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study predates GLP
- Specific details on test material used for the study:
- - Name of test material: Boric acid
- Molecular formula: H3BO3
- Molecular weight: 61.8
- Smiles notation: B(OH)3
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: > 99.9 % w/w
- Stability under test conditions: Stable
- Other: White and odourless. - Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Six rabbits with intact and 6 rabbits with abraded skin. 5 mL of boric acid was applied as a 10 % solution on a cellulose pad.
- Concentration: 10 % solution
Duration of treatment / exposure: No data
Observation period: No data
Number of animals: 12 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.7
- Max. score:
- 8
- Reversibility:
- other: no data
- Remarks on result:
- other: intact plus abraded skin
- Other effects:
- no data
- Conclusions:
- Interpretation of results: not irritating
Remarks: Migrated information Criteria used for interpretation of results: not specified
Conclusions:Not irritating
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety evaluation of some humectants and moisturizers used in cosmetic formulations.
- Author:
- Guillot JP, Martini MC, Giauffret JY, Gonnet JF, Guyot JY
- Year:
- 1 982
- Bibliographic source:
- International Journal of Cosmetic Science 4: 67-80
Materials and methods
- Principles of method if other than guideline:
- Draize Test: test procedure as described in the Journal Officiel de la République Francaise
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2-hydroxyethoxy)ethan-1-ol
- Cas Number:
- 111-46-6
- Molecular formula:
- C4H10O3
- IUPAC Name:
- 2-(2-hydroxyethoxy)ethan-1-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 2.5 kg
- Housing: in individual cages
- No further details provided
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,5 ml
- Duration of treatment / exposure:
- 23
- Number of animals:
- 6
- Details on study design:
- Details on study design:
TEST SITE
- Area of exposure: 4 cm x 4 cm; application area with and without scarification
- Type of wrap if used: occlusive patches "Neodermotest", fixed using absorbent gauze held in place by adhesive tape.
SCORING SYSTEM: Draize-score system; determination of the primary cutaneous irritation index.
- The substance was considered to be a non irritant if the score was less than 0.5
- The substance was considered to be slightly irritant if the score was between 0.5 and 2.0
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other:
- Remarks:
- mean max cutaneous index
- Basis:
- mean
- Time point:
- other: No data
- Score:
- ca. 0.04
- Remarks on result:
- other: Undiluted DEG
- Irritation parameter:
- other:
- Remarks:
- mean max cutaneoud index
- Basis:
- mean
- Time point:
- other: six weeks
- Score:
- ca. 0.47
- Remarks on result:
- other: undiluted DEG
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: six weeks
- Score:
- ca. 0
- Remarks on result:
- other: 10% sol. in water
- Irritant / corrosive response data:
- Undiluted DEG: PII: 0.04; 6 -week cumulative cutaneous irritation: well tolerated (MMII = 0.47)
10% solution: 6 -week cumulation cutaneous irritation: very well tolerated (MMII = 0)
PII = primary cutaneous irritation index;
MMII = mean maximum cutaneous index.
Any other information on results incl. tables
In their pure form, humectants are particularly well tolerated in primary cutaneous irritation for nearly all these indices approximate to 0 and so correspond to a non-irritant application.
Applicant's summary and conclusion
- Conclusions:
- GHS criteria for classification not met
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