Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
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

Constituent 1
Chemical structure
Reference substance name:
Sodium bromide
EC Number:
231-599-9
EC Name:
Sodium bromide
Cas Number:
7647-15-6
Molecular formula:
NaBr
IUPAC Name:
Active bromine generated from sodium bromide and sodium hypochlorite
Details on test material:
Sodium bromide
lot 7320
purity 99.23 %

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.