Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: None OECD 404 and non GLP. "Appraisal of Safety of Chemicals in Foods, Drugs, and Cosmetics"(1959) Texas, State Department of Health, Austin

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity:>99.9%

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
no dilute 0.5 g

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
Group A: 5min+washed
Group B: 1h+washed
Group C: 24h
Observation period:
24h, 48h, 72h, 96h and 5d after dosing
Number of animals:
6
Details on study design:
The degrees of erythemia, crusting and edema were recorded

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 5min
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: no irritation were observed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: no irritations were observed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours dosing
Score:
1.63
Max. score:
2.33
Remarks on result:
other: very slight erythema was found in 3 of 6 animals, and slight edema was noted in all animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0.39
Max. score:
1
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
1.67
Max. score:
2
Reversibility:
not fully reversible within: 5 days
Irritant / corrosive response data:
Irritating Index of Skin Reaction
Days after Dosing
1 day 2 day 3 day 4 day 5 day
Group A: 0 0 0 0 0
Group B: 0 0 0 0 0
Group C: 2.33 2.17 1.67 1.17 0.83
Other effects:
no data

Any other information on results incl. tables

Irritation Index

 Groupe  1 day 2 day  3 day  4 day   5 day 

A (patched for 5 min and washed)

 0

B (patched for 1 hr and washed)

 0

C (patched for 24 h)

 2.33  2.17 1.67 1.17  0.83 

Group C: very slight erythema was found in 3 of 6 animals, and slight edema was noted in all animals. Thereafter erythemia disappeared almost completely. Edema was gradually improved from the end of the third day, but persisted in 3 animals on the fifth day.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Classification: irritating
Executive summary:

In a primary dermal irritation study , 6/ males, albino rabbits from The Expeimental Animal Research of Medicine (2.5 - 3.0 kg / 6 animals) were dermally exposed to 0.5 g of PMI (provided by NIPPON SHOKUBAI on 1984.08.20) in undiluted PMI with three patches of 1 inch in diameter. Test sites were covered with a semi-occlusive dresssing for 5 min, 1 hour, 24 hours, respectively. Animals were then observed for 5 days.  Irritation was scored by the method of Draize. The was slightly to moderately.

No irritations were observed in the washed groups.

In this study, PMI is classified as slightly to moderately irritating (the category 2 in accordance with GHS) to the skin.