Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 February 1988 to 20 July 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): PEP-36
- Physical state: White powder
- Purity: 100%
- Date of receipt: 18 February 1988
- Storage condition of test material: At room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: young adult
- Weight at study initiation: not reported
- Housing: screen-bottomed cages
- Diet: 120 g per day certified high fibre rabbit diet
- Water: ad libitum
- Acclimation period: 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled conditions but value/range not reported
- Humidity (%):humidity controlled conditions but value/range not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark

IN-LIFE DATES: From: 8 March To: 11 March 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg moistened with 0.5 ml of tap water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area approximately 6 cm2
- % coverage: not reported
- Type of wrap if used: non-absorbent binder secured with porous tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were wiped with gauze and tap water to remove any test material residue.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize technique

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Irritant / corrosive response data:
There was no erythema, edema or any other dermal effects noted at any time during this study.
Other effects:
No mortality occurred during the study.

Any other information on results incl. tables

Animal

Sex

Observation interval

30-60 min

24 h

48 h

72 h

Erythema

1

M

0

0

0

0

2

M

0

0

0

0

3

M

0

0

0

0

4

F

0

0

0

0

5

F

0

0

0

0

6

F

0

0

0

0

Edema

1

M

0

0

0

0

2

M

0

0

0

0

3

M

0

0

0

0

4

F

0

0

0

0

5

F

0

0

0

0

6

F

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No mortality, erythema, edema or any other dermal effects noted at any time during the study. Based on the results of the study, PEP-36 is not a dermal irritant.