Registration Dossier
Registration Dossier
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EC number: 231-830-3 | CAS number: 7758-02-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium bromide
- EC Number:
- 231-599-9
- EC Name:
- Sodium bromide
- Cas Number:
- 7647-15-6
- IUPAC Name:
- sodium bromide
- Details on test material:
- Sodium bromide
lot 7320
purity 99.23 %
Potassium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to potassium bromide.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- other: 0.5 g in 0.5 ml
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 4 days
- Number of animals:
- 6
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Other effects:
- no furher details
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with CLP Regulation (EC) No 1272/2008, no classification and labelling with respect to skin irritation is required.
- Executive summary:
The test substance was moistened with water and administered dermally to a small patch of shaven skin of 6 female rabbits and covered for 4 hours each. Observations of the resulting skin condition were made 30 minutes after test substance removal, and daily thereafter for 4 days.
All 6 animals showed no response to treatment.
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