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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Principles of method if other than guideline:
The study was conducted according to the method outlined by Draize et al.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Epoxide No. 8

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
no details given

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.08
Reversibility:
no data
Remarks on result:
probability of moderate irritation
Remarks:
Cumulative scores and mean values provided
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of moderate irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Primary Irritation Index = 4.08

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
Undiluted Epoxide No. 8 produced moderate primary irritation upon prolonged exposure to rabbits' skin by closed patch technique.
Executive summary:

Three New Zealand Albino rabbits per group, were treated with  0.5ml of Epoxide 8, applied to a 1" x I" l2-ply gauze pad. The pads were taped on both an intact and abraded site on each animal.. The narrow adhesive tape was crossed in an ‘X’ to hold the gauze pad but not to occlude the ventilation.

After 24 hours, the animals were removed from the stocks, patches were removed and the resulting-reactions evaluated on the basis of scores indicated by Draize. The cumulative scores (24 and 72 hours; abraded and intact) are averaged separately for both erythema and edema and are then added together to arrive at a Primary Irritation Index.

Undiluted Epoxide No. 8 produced moderate primary irritation (PII = 4.08) upon prolonged exposure to rabbits' skin by closed patch technique.