Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 June 2014 to 20 June 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl

EC Number:

943-540-0

Molecular formula:

Too complex

IUPAC Name:

Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl

Test material form:

other: pale amber liquid

Details on test material:

Purity: 100%
Physical state / Appearance: pale amber liquid
Expiry date: 09 May 2016
Storage Conditions: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

At the start of the study the animals weighed 2.20 or 2.70 kg and were twelve to twenty weeks old.
Acclimatation period of at least 5 days.
The animals individually housed.
Free access to water and food.
Temperature between 17 and 23°C
Humidity between 30 and 70%
The relative air exchange was at least fifteen changes per hour and the lighting was controlled to give 12 hours continuous light (06.00 to 18.00) and twelve hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test item

Duration of treatment / exposure:

Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.

Observation period:

Immediately following removal of patches and approximatively 1, 24, 48 and 72 hours later examination for evidence of primary irritation and scored according to the Draize scoring.

Number of animals:

2 males

Details on study design:

On the back of the rabbit. Product directly applied to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches the trunk of each rabbit was strapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

The body weight of the animal #74413 increased from 2.70 to 2.76 kg at day 3.
The body weight of the animal #74414 increased from 2.20 to 2.25 kg at day 3.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced a primary irritation index of 0.0 and was not classified according to the Draize classification scheme and not classified according to EU regulation. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Method B.4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced no erythema and no edema. Both treated skin sites appeared normal at the 7-Day observation.

Conclusion

The test item produced a primary irritation index of 0.0 and was not classified as irritant to rabbit skin according to the Draize classification scheme and not classified according to EU classification. No corrosive effects were noted.