Nonylphenol, branched, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye 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 405 in compliance with GLP. Analytical certificate not included in study report.

Cross-reference

Reason / purpose for cross-reference:

reference to same 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

other: HC:NZW

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye treated, the other left untreated and served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 h, after which eye was rinsed with saline solution.

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No effects reported on cornea, iris or conjunctiva at any of the timepoints.

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 eyes.

Executive summary:

A study was conducted to determine the eye irritation potential of the substance in rabbit according to OECD Guideline 405. 100 µl of undiluted substance were instilled into one eye of each of 3 rabbits, then rinsed after 24 hours with saline solution. The other eye was left untreated and served as control. Effects on cornea, iris and conjunctivae were evaluated after 1, 24, 48 and 72 h, as well as after 7, 14 and 21 d according to the Draize scoring system. Other effects were also recorded. No symptoms were observed at any of the time points. Based on these findings, the substance was considered to be non-irritating to eyes under the conditions of the study (Märtins T, 1988).