Registration Dossier
Registration Dossier
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EC number: 215-575-5 | CAS number: 1332-77-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 173.240 under Title 49 of the code of Federal Regulations (Federal Register, 1973).
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
Test material
- Reference substance name:
- potassium tetraborate
- IUPAC Name:
- potassium tetraborate
- Details on test material:
- - Name of test material: Potassium tetraborate powder.
- Physical state: White powder with a slight odour.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 h
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch by 1 inch on the saddle.
- % coverage:
- Type of wrap if used: 12-ply surgical gauze held in place with adhesive tape. After application of the patches, the trunk of each rabbit was wrapped with rubber dental damming secured with staples.
REMOVAL OF TEST SUBSTANCE
- Washing: Gently sponged with a moistened towel.
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: Result on intact skin.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: Result on abraded skin.
- Irritant / corrosive response data:
- Very slight erytehma was noted. No corrosive effects were noted at any time.
Any other information on results incl. tables
Primary irritation and corrosive scores in rabbits following a 4-h patch application of potassium tetraborate powder:
Rabbit No. |
Skin |
Erythema-Eschar Observation |
Edema Observation |
||||
4 h |
24 h |
48 h |
4 h |
24 h |
48 h |
||
55 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
56 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
57 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
1 |
1 |
0 |
0 |
0 |
0 |
|
58 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
59 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
60 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
1 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The corrosive potential of potassium tetraborate was assessed and found not corrosive according to Section 173.40 under Title 49 of the Code of Federal Regulations (Federal Register, 1973).
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