2,3,5-trimethylphenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from NTRL reports

Data source

Reference

Reference Type:

review article or handbook

Title:

NONYLPHENOL: SKIN CORROSIVITY EVALUATION IN RABBITS

Author:

UNION CARBIDE CORP

Year:

1982

Bibliographic source:

OTS0573384, submitted by UNION CARBIDE CORP, last updated 09/10/82

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DOT regulation 173.1300 Appendix A – Method of Testing Corrosion to Skin (46 FR 49889, October 8. 1981, effective July 1. 1982).

Principles of method if other than guideline:

A study was performed in rabbits to assess the skin corrosive potential of 4-nonyl phenol

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

p-nonylphenol

EC Number:

203-199-4

EC Name:

p-nonylphenol

Cas Number:

104-40-5

IUPAC Name:

4-nonylphenol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):4-Nonylphenol
- Molecular formula : C15H24O
- Molecular weight : 220.354 g/mol
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report):4-Nonylphenol
- Molecular formula : C15H24O
- Molecular weight : 220.354 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc.
Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: 2.5 – 3.0 kg
- 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: 30 days. All animals were checked for viability twice daily. Prior to assignment to study all animals were examined to ascertain their suitability for study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-70°F [15- 21deg C]
- Humidity (%): monitored daily
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and intact

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:

TEST SITE
- Area of exposure: left side of the spinal
column
- % coverage: 1inch*1inch
- 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: after 4 hours of exposure

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

48 h

Max. score:

4.9

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

Irritation generally consisted of slight or very slight erythema and edema at 4 hours. At termination of the study (48 hours), however all animals exhibited evidence of corrosivity and tissue damage {necrotic skin)

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

A study was performed in 6 young adult New Zealand White albino rabbits to assess the skin corrosive potential of 4-nonyl phenol.
Irritation generally consisted of slight or very slight erythema and edema at 4 hours. At termination of the study (48 hours), however all animals exhibited evidence of corrosivity and tissue damage {necrotic skin).
The Primary Irritation Index after 48 hours was 4.9.
Based on the score and observations, 4-nonylphenol was considered to be corrosive to skin

Executive summary:

A study was performed in 6 young adult New Zealand White albino rabbitsto assess the skin corrosive potential of 4-nonyl phenol. The study was conducted according toDOT regulation 173.1300 Appendix A – Method of Testing Corrosion to Skin (46 FR 49889, October 8. 1981, and effective July 1, 1982) Guidelines. 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. There was one test site per animal, on the left side of the spinal column. Five-tenths milliliter (0.5 ml) of p-nonyl phenol applied beneath a surgical gauze square, 1inch*1inch was placed directly on the test site and held in place with tape. Plastic sheeting was then wrapped around the animals and secured with tape to retard evaporation and keep the test substance in contact with the skin without undue pressure. Following approximately 4 hours of exposure, the wrappings and gauze squares were removed and the test si tes wiped free of excess test material with castille soap and water. Observations were made for erythema and edema or other evidence of dermal irritation or injury 30 minutes after removal of the occlusive wrapping. i.e., approximately 4.5 hours. Irritation generally consisted of slight or very slight erythema and edema at 4 hours. At termination of the study (48 hours), however all animals exhibited evidence of corrosivity and tissue damage {necrotic skin). The Primary Irritation Index after 48 hours was 4.9.

Based on the score and observations, 4-nonylphenol was considered to be corrosive to skin.