Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Exposure continued for 24 hours instead of 4 hours, no observations planned past 72 hours following initial application
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
Exposure continued for 24 hours instead of 4 hours, no observations planned past 72 hours following initial application
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Iso-octane
- Analytical purity:100% pure commercial product

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Single application for 24 hours
Observation period:
72 hours
Number of animals:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (24-hour exposure)
-Time after start of exposure: 24 hours


SCORING SYSTEM: OECD Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
other: Primary irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0.25
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
Very slight erythema (grade 1) noted on abraded sites of 3 of 6 rabbits and intact sites of 3 of 6 rabbits at 72 hours post application. No other dermal effects were noted in the study.
Other effects:
No effects.

Any other information on results incl. tables

Initial protocol did not include provision for observation until reversibility up until 14-day observation period. Even though complete reversibility was not observed it was anticipated as was observed with irritation in dermal LD50 study.

 

The test substance was irritating to the skin based on persistent irritation at study termination.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP
Executive summary:

The test substance was irritating to the skin based on persistent irritation at study termination.