Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Severe effects seen in three rabbits.  Study terminated after 3 days for humane reasons

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Severe effects seen in three rabbits.  Study terminated after 3 days for humane reasons
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Sodium isobutyl xanthate
IUPAC Name:
Sodium isobutyl xanthate
Test material form:
solid - liquid: suspension
Details on test material:
- Physical state: orangee liquid- Analytical purity: 456,1g/dm3- ph=10.1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Age: 4 monthWeight: 2.9 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
0,5 ml of water solution pH=10, containing 456,1g/dm3 of SIX, on 2,5x25cm of shaved skin
Duration of treatment / exposure:
4 hours exposure
Observation period:
1; 24; 48 and 72 h
Number of animals:
3 male

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Terminated at 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours.
Remarks on result:
other: Terminated at 72 hours
Irritant / corrosive response data:
observation after 1h – bloody effusions, moderate swelling, oedema, after 24 ,48 and 72h – tinea on the exposition place and around redness, oedema.

Any other information on results incl. tables

   Animal nr  1 24 48 72
 erythema 1 4 4 4 4
  2 4 - - -
   3  4 4 4 4
  oedema  1 3 3 3 3
   2  3 - - -
   3  3 3 3 3 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Sodium isobutyl xanthate can be assessed as a substances strongly irritating skin of rabbits
Executive summary:

Severe effects seen in three rabbits.  Study terminated after 3 days for humane reasons