Registration Dossier
Registration Dossier
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EC number: 211-706-5 | CAS number: 688-74-4
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:
- key study
- Justification for type of information:
- justification for analogue approach: see IUCLID section 13 "Read-across justification"
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: experimental study on hydrolysis product Boric acid
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 163)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan F Plummer
- Weight at study initiation: 1623 - 2922 g - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: Moistened with physiological saline. - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: Saddle area
- Type of wrap if used: Occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: Moistened towel
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- No irritancy was observed
- Other effects:
- No data
- Interpretation of results:
- other: Not classifiable in the EU
- Remarks:
- Criteria used for interpretation of results: other: Classified in US Toxicity Category IV (slight or no irritation)
- Conclusions:
- The study was performed according to FIFRA (40 CFR 163). No irritancy was observed and it is therefore not classifiable in the EU.
Classified in US in Toxicity Category IV (slight or no irritation).
Data from other studies confirm the results. Further testing not warranted in the interests of animal welfare.
Results for skin irritation:
Site |
Time |
Erythema |
Edema |
Intact |
24 h |
0 |
0 |
72 h |
0.25 |
0 |
|
Abraded |
24 h |
0 |
0 |
72 h |
0.17 |
0 |
|
Average score |
24 h, 72 h |
0.105 |
0 |
Data source
Materials and methods
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- H3BO3
- IUPAC Name:
- Boric acid
- Details on test material:
- - 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: >99.0 % w/w
- Lot/batch No.: OA 107-3
- Stability under test conditions: Stable
- Other: White powder and odourless
Constituent 1
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- No irritancy was observed
- Other effects:
- No data
Any other information on results incl. tables
Results for skin irritation:
Site |
Time |
Erythema |
Edema |
Intact |
24 h |
0 |
0 |
72 h |
0.25 |
0 |
|
Abraded |
24 h |
0 |
0 |
72 h |
0.17 |
0 |
|
Average score |
24 h, 72 h |
0.105 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classifiable in the EU
- Remarks:
- Criteria used for interpretation of results: other: Classified in US Toxicity Category IV (slight or no irritation)
- Conclusions:
- The study was performed according to FIFRA (40 CFR 163). No irritancy was observed and it is therefore not classifiable in the EU.
Classified in US in Toxicity Category IV (slight or no irritation).
Data from other studies confirm the results. Further testing not warranted in the interests of animal welfare.
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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