Montan wax

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study following OECD test guideline 405 under GLP

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:

in vitro HET-CAM Test was applied

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Montan wax

EC Number:

232-313-5

EC Name:

Montan wax

Cas Number:

8002-53-7

Molecular formula:

As montan wax is a UVCB, a molecular formular cannot be specified.

IUPAC Name:

Montan wax

Test animals / tissue source

Species:

other: not applicable as invitro HET-CAM was used

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable, but in vitro a negative and two positive controls were used

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300ml (i.e. approx. 167.5 mg)

Duration of treatment / exposure:

300 seconds

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

not applicable as in vitro test was used (in the HET-CAM six eggs were used for the test substance and three eggs per control)

Details on study design:

SCORING SYSTEM: Irritation score (IS) based on time until haemorrhage, time until lysis and time until coagulation
IS=((301-seconds until haemorrhage)/300)*5 + ((301-seconds until lysis)/300)*7 + ((301-seconds until coagulation)/300)*9

Results and discussion

In vivo

Results

Irritation parameter:

other: irritation score

Basis:

mean

Time point:

other: 300 seconds

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: classification based on IS

Conclusions:

Based on the results of an in vitro HET-CAM test following OECD test guideline 405 under GLP, the test substance is considered not irritating to the eye.

Executive summary:

An in vitro HET-CAM study was performed to assess the irritating potential of the test substance by detection

of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature.

Physiological sodium chloride solution was used as negative control, sodium dodecyl sulphate (1% solution) and sodium hydroxide (0.1-N solution) were used as positive controls.

The positive controls induced a severe irritation on the blood vessels. The negative control showed no irritation, the irritation score for the positive controls lay within the demanded range.

The test item was tested pure. A mean irritation score of 0.0 was calculated, corresponding to a classification as not irritant.

No observations were made which might cause doubts concerning the validity of the study outcome.