Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ICCVAm Test Method Evaluation Report: Appendix G -> ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)

Deviations:

no

Principles of method if other than guideline:

Additional information was taken from:
- Background Review Document; "Current Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Hen's Egg Test - Chorioallantoic Membrane Test Method (March 2006, NIH Publication No. 06-4515)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate

EC Number:

700-393-5

IUPAC Name:

Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate

Details on test material:

- Lot/batch No.: F11101
- Expiration date of the lot/batch: Feb 2011
- Stability under test conditions: yes
- Storage condition of test material: Room Temperature: (20 ± 5°C); keep away from light and humidity.

Test animals / tissue source

Species:

other: chicken eggs

Strain:

other: Lohmann selected Leghorn chicken´s eggs

Details on test animals or tissues and environmental conditions:

TEST SYSTEM
- Source: LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany)
- Age at study initiation: 9 days
- Weight at study initiation: 50-60 g
- Housing: incubator

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 38.5 °C
- Humidity (%): 58-60 %
- Air changes (per hr): no air change
- Photoperiod (hrs dark / hrs light): not necessary

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): pure

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

5 minutes

Number of animals or in vitro replicates:

not applicable

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 5 min

Score:

10.83

Reversibility:

other: absence of the possibility to assess reversibility (HET CAM test)

Other effects:

no

Any other information on results incl. tables

1) Observations

The observations which were made are given in the following table:

Table: Experimental Observations

Test Group	Amount applied	Time until Haemorrhage	Time until Lysis	Time until Coagulation
	[µL]	[s]	seconds	seconds
Negative Control	300	301	301	301
	300	301	301	301
	300	301	301	301
Positive Control 0.1-N NaOH	300	9	21	15
	300	7	20	15
	300	5	20	13
Positive Control 1% SDS	300	10	23	301
	300	12	25	301
	300	11	21	301
Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate and tris 2-biphenylyl phosphate	300	28	30	301
	300	27	31	301
	300	27	32	301
	300	28	32	301
	300	29	32	301
	300	30	33	301

2) Calculation of Irritation Score (IS)

The irritation score was calculated from the following equation:

IS = [(301 - time until haemorrhage)/300]*5 + [(301 - time until lysis)/300]*7 + [(301 - time until coagulation)/300]*9

The calculated IS for each replicate and the corresponding means are presented in the following table:

Table: Experimental Observations

Test Group	Irritation Score	Mean Irritation Score
Negative Control	0.00	0.00
	0.00
	0.00
Positive Control 0.1-N NaOH	19.98	20.05
	20.04
	20.13
Positive Control Na-dodecylsulphate, 1 %	11.34	11.32
	11.26
	11.37
Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate and tris 2-biphenylyl phosphate	10.87	10.83
	10.87
	10.84
	10.83
	10.81
	10.77

3) Classification

Classification of the irritation potential is made as stated in the following table:

Table: Classification

Irritation Score (IS)	Classification
0-0.9	not irritant
1 -4.9	slightly irritant
5-8.9	moderately irritant
9-21	severely irritant

In the negative control, no signs of irritation were observed. Both positive controls showed severe irritation.

The test item 'Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate and tris 2-biphenylyl phosphate' showed severe irritation.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item 'Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate and tris 2-biphenylyl phosphate' showed severe effects on the blood vessels of the CAM. The calculated mean irritation score is 10.83.
In conclusion, it can be stated that the test item possesses severe irritation potential.