Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 April 1980 - 21 April 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kuiper’s Rabbitry, Gary, IN, USA.

- Age at study initiation: approximately 14 weeks of age.

- Weight at study initiation: average for male was 2577 g, average for female was 2277g.

- Housing: animals were maintained individually in screen bottom cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum): No data available.

- Water (e.g. ad libitum): ad libitum.

- Acclimation period: at least 7 days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled environment, but no temperature provided.

-Humidity (%):controlled environment, but no humidity information provided.

-Air changes: controlled environment, but no air change information provided.

-Photoperiod: controlled environment, but no photoperiod information provided.

IN-LIFE DATES: From: 04/02/1980 To: 04/21/1980.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 ml/site

- Concentration (if solution): undiluted.


VEHICLE

- Amount(s) applied (volume or weight with unit): Not applicable.

- Concentration (if solution): Not applicable.

- Lot/batch no. (if required): Not applicable.

- Purity: Not applicable.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
- Area of exposure: no data.

- % coverage: treated area was covered with a 5.0 cm x 5.0 cm gauze patch.

- Type of wrap if used: the gauze was overwrapped with Saran wrap and elastoplast tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): no.

- Time after start of exposure: 24 h


SCORING SYSTEM: Draize (1965).

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0.6
Max. score:
1.5
Reversibility:
no data
Irritant / corrosive response data:
See Table 1 for Skin reactions
Other effects:
No data.

Any other information on results incl. tables

Table 1: Individual Skin Reactions

Sex

Animal No.

Erythma

Edema

Intact site

Abraded site

Intact site

Abraded site

Male

1

1.0

1.0

0

0

2

1.0

1.0

1.0

1.0

3

1.0

1.0

0

0

Female

4

1.0

1.5

0

0

5

1.0

1.0

0

0

6

1.0

1.0

0

0

Average of 24 -hour

1.0

Average of 72-hour

0.2

Primary Irritation Index

0.6

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FHSA regulations
Conclusions:
To FHSA regulations, the test material is not a primary skin irritant
Executive summary:

In a primary dermal irritation study in the rabbit male and female animals were dermally exposed to 0.5 ml of the substance for 24 hours. Animals were observed for 72 hours. Irritation was scores by the Draize classification scheme.

No corrosive effects were noted during the study and the substance produced a primary irritation index of 0.6.

The substance is not classified according to the FHSA regulations as non-irritant for skin.