Phosphorus

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well performed and reported non GLP study similar to current OECD 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FDA 16 CFR 1500.42 91 26,142

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

study performed before GLP guidelines

Test material

Test material information

Constituent 1

Reference substance name:

phosphorus

EC Number:

918-594-3

Cas Number:

7723-14-0

Molecular formula:

(P)n (Phosphorus red modification)

IUPAC Name:

phosphorus

Constituent 2

Reference substance name:

Phosphorus

EC Number:

231-768-7

EC Name:

Phosphorus

Cas Number:

7723-14-0

IUPAC Name:

phosphine

Details on test material:

- Name of test material (as cited in study report): oiled red phosphorus 8Albright and wilson, LDT. Lot LT 22 RED PHOSPHORUS)
- Substance type: element
- Physical state: solid / powder
- Analytical purity: > 94,6 % +- 1,20 %
- Impurities (identity and concentrations): < 0,0055 % +- 0,0020 % yellow phosphorus
- Composition of test material, percentage of components:approx. 94,6 % total phosphorus, 0,08 % +- 0,010 % mineral oil

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: B and H Rabbitry, Rockville, MD, USA
- Age at study initiation: 10 week old
- Housing: wired bottom cages
- Diet (e.g. ad libitum): Purina Rat Chow
- Water (e.g. ad libitum): Acified water (pH 2.5)
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72° to 76°F
- Humidity (%): 39 to 54 percent relative humidity
- Photoperiod (hrs dark / hrs light): 12h dark / 12h with artificial illumination.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

100 mg of the dry material was applied

Duration of treatment / exposure:

24 hour

Observation period (in vivo):

1, 24, 48 and 72 hour

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): sterile isotonic saline solution
- Time after start of exposure: 24 hour
- 100 mg of the dry material was applied to the eye by pulling out the lower eyelid to form a cup.
Only one eye was treated, the other served as control.
Three animals were treated in the right eye, three animals were treated in the left eye.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24h

Score:

0

Max. score:

4

Reversibility:

other: n.a.

Remarks on result:

other: not irritating

Irritant / corrosive response data:

not irritating

Other effects:

none

Any other information on results incl. tables

The Instillation of 100 mg of oiled red phosphorus into rabbit eyes did not produce any irritation or injury to the cornea or iris. The conjunctivae of all rabbits showed a slight redness 1 hour after treatment. In one rabbit, a slight redness was also apparent at 24 hours. Five of six rabbits treated with the test material showed slight swelling at t hour post-treatment which was not present at 24-hours posttreatment. From these results it was concluded that oiled RP was neither corrosive or irritating to the eye.

CONJUNCTIVAE IRRITATION STUDY OF OILED RED PHOSPHORUS IN RABBITS
	Redness					Chemosis
Rabbit
Number	Hours				Day	Hours				Day
	1	24	48	72	7	1	24	48	72	7
2360D	<1	0	0	0	0	1	0	0	0	0
2361D	<1	<1	0	0	0	1	0	0	0	0
2362D	<1	0	0	0	0	1	0	0	0	0
2363D	<1	0	0	0	0	1	0	0	0	0
2364D	<1	0	0	0	0	0	0	0	0	0
2365D	<1	0	0	0	0	1	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The Instillation of 100 mg of oiled red phosphorus into rabbit eyes did not produce any irritation or injury.

Executive summary:

The Instillation of 100 mg of oiled red phosphorus into rabbit eyes did not produce any irritation or injury to the cornea or iris. The conjunctivae of all rabbits showed a slight redness 1 hour after treatment. In one rabbit, a slight redness was also apparent at 24 hours. Five of six rabbits treated with the test material showed slight swelling at t hour post-treatment which was not present at 24-hours posttreatment. From these results it was concluded that oiled Red Phosphorus was neither corrosive nor irritating to the eye.