4-hydroxybenzoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-12-03 to 2009-01-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD draft guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Draft guideline OECD 405 dated 2002-04-24

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxybenzoic acid

EC Number:

202-804-9

EC Name:

4-hydroxybenzoic acid

Cas Number:

99-96-7

Molecular formula:

C7H6O3

IUPAC Name:

4-hydroxybenzoic acid

Details on test material:

Name: p-Hydroxybenzoesäure
composition: para-Hydroxybenzoic acid
Batch No.: 08/1000/10, 1-20
date of production: 2008-10-20
purity 99.94%, white powder
storage: 15°C-25 °C, dry and dark
date of expiry: 01.10.2011

Test animals / tissue source

Species:

other: Lohmann selected Leghorn chicken's eggs

Strain:

other: Lohmann Leghorn

Details on test animals or tissues and environmental conditions:

Freshly laid Lohmann Leghorn chicken eggs
- Source: LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany, arrived on 05th Dec. 2008, 9 days before the start of the test)
Eggs were incubated at 36.5°C-37.5°C for eight days,
During incubation eggs were rotated to prevent an attachment of the embryo to one side of the egg.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

no data
50% of the surface of the membrane were coverd with the test item.

Duration of treatment / exposure:

300 seconds

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

6 for the test substance
3 for negative control
3 for positive control 0.1% NaOH
3 for postive control 1% SDS

Details on study design:

Negative control: physiological NaCl Solution
Positive controls:
- Sodium Dodecyl Sulfate Solution (C12H25NaO4S, CAS-No. 151-21-3, 10 g/L solution in deionised water)
- Sodium Hydroxide Solution 0.1 N (NaOH, CAS-No. 1310-73-2, dissolved in deionised water, 4 g/L)

Test vessels: made of glass or sterilizable plastic, sterilisation before use (either heating to 180°C for 2 hours, or autoclavation)

Preparation of the test system:
non-vialble eggs (observed by using a candle) were discarded 24 hours before the experiment (incubation)

Method description
After opening of the egg at the day of the test, the inner membrane was moistened with 0.9% NaCl, the egg was left to stand
in the incubator for 30 min and then the solution was decanted and the inner membrane was removed with foreceps.
Then the test substance was directly given to the CAM (chorio-allantoic-membrane) surface in such a manner, that approx.
50 % of the membrane was covered with the solid test substance.
The reactions on the CAM were observed for 300 seconds regarding the endpoints:
-haemmorrhage (bleeding of blood vessels)
-vascular lysis (blood vessel disintegration)
-coagulation (protein denaturation)

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

The test item p-Hydroxybenzoesäure was tested in the HET-CAM-Test according to Draft guideline OECD 405 dated 2002-04-24 with Lohmann Leghorn chicken eggs. Following an 8 day incubation period the CAM was exposed with the solid test item for 5 min and obs

Value:

0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: according to the guideline used

Conclusions:

The negative controls showed no irritation, the positive controls showed severe irritations and the test item applied
as a solid showed no irritations.

Executive summary:

The test item p-Hydroxybenzoesäure was tested in the HET-CAM-Test according to Draft guideline OECD 405 dated 2002-04-24 with Lohmann Leghorn chicken eggs. Following an 8 day incubation period the CAM was exposed with the solid test item for 5 min and observed for 5 min.

The Irritating Score was 0.0 in all six replicates of the test item. Negative controls showed no irritating effects. The 2 positive controls induced severe irritation.

The test item p-Hydroxybenzoesäure under this experimental conditions of this study possesses no irritation potential. The non irritating results of this in-vitro test system are not sufficient for classification as not irritating according to EU-GHS (CLP-Regulation).