Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data from study report

Data source

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

Materials and methods

Principles of method if other than guideline:
Skin corrosivity evaluation of 4-Nonylphenol in rabbit.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nonylphenol
- Molecular formula (if other than submission substance): C15-H24-O
- Molecular weight (if other than submission substance): 220.354 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: Dutchland Laboratories, Inc.
Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Individually housed, Suspended, stainless steel cage.
- Diet (e.g. ad libitum): Purina lab Rabbit Chow HF (#5326), ad libitum
- Water (e.g. ad libitum): automatic watering system, ad libitum Municipal water supply (Elizabethtown water Co.)
- Acclimation period: No data available

Or Test Tissue
- Source: No data available
- Type: No data available
- Acclimation : No data available
- Housing conditions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-70°F
- Humidity (%): monitored daily
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: To: No data available

Test system

Type of coverage:
other: Plastic sheeting was wrapped around the animals and secured with tape
Preparation of test site:
other: On the day before dosing the hair of each rabbit was closely clipped from the back with an electric clipper, so as to expose the back from the scapular to the lumbar region. The skin at the site remained intact; no abrasions were made.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
48 h
Number of animals:
Six (3 male & 3 female)
Details on study design:
Details on study design
TEST SITE
- Area of exposure: left side of the spinal
column
- % coverage: No data available
- Type of wrap if used: Plastic sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites wiped free of excess test material with castile soap and water.
- Time after start of exposure: No data available

SCORING SYSTEM: No data available

Results and discussion

In vivo

Results
Irritation parameter:
other: erythema and edema, corrosivity and tissue damage (necrotic skin)
Basis:
mean
Time point:
other: 48 Hr
Reversibility:
no data
Remarks on result:
other: other details not known
Irritant / corrosive response data:
corrosive to the rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance Nonylphenol is corrosive to the rabbit skin.
Executive summary:

Skin irritation test of Nonylphenol was conducted inNew Zealand WhiteAlbino rabbit. 0.5 ml of the test substance was applied on the clipped back skin of rabbit for 4 h. At termination of the study (48 hours). However, all animals exhibited evidence of corrosivity and tissue damage {necrotic skin). Thus, under conditions of this study, Nonylphenol is corrosive to the skin.