Nonylphenol, branched, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16 March to 06 July 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD Guideline 404 in compliance with GLP. Analytical certificate not included in study report.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nonylphenol, branched, ethoxylated

EC Number:

500-209-1

EC Name:

Nonylphenol, branched, ethoxylated

Cas Number:

68412-54-4

Molecular formula:

not available for this UVCB

IUPAC Name:

Nonylphenol, branched, ethoxylated (> 1 < 2.5 mol EO)

Test animals

Species:

rabbit

Strain:

other: HC:NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Ltd., UK
- Housing: Macrolon Type III cages
- Diet (e.g. ad libitum): Standard Ssniff K4 diet (Soest/Westfalen GmbH)
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl undiluted substance

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: substance applied rto hypoallergenic Hansamed bandage (Beiersdorf 2342), fixed with an elsatic bandage to provide semi-acclusive conditions

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Remarks on result:

other: see below section 'Irritant/corrosive response data'

Irritant / corrosive response data:

No effects observed in two animals. Grade 1 erythema seen until and including 48 h timepoint in one animal, no longer observed at 72 h. Overall score for this animal: 0.7

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, the substance was not irritating to skin.

Executive summary:

A study was conducted to determine the skin irritation potential of NPEO in rabbit according to OECD Guideline 404. 500 µl of undiluted test substance were applied by patch under semi-occlusive conditions to the shaved skin of 3 rabbits. The patch was removed after 4 h and the skin washed with water. Erythema, scarring and eodema were evaluated after 1, 24, 48, 72 h and 7 and 14 d according to the Draize scoring system. Other effects were also recorded. No effects observed in two animals. Grade 1 erythema was seen until and including the 48 h timepoint in one animal, but no longer observed at 72 h. The overall score for this animal was 0.7. Based on these findings, the substance was considered to be non-irritating to skin under the conditions of the study (Märtins T, 1988).