Phosphorus

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404.

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 1500.41 91 26,141

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 h exposure

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 Albright 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: sterile isotonic saline solution

Controls:

no

Amount / concentration applied:

0.5 g of red phosphorus was mixed with 0,5 ml sterile isotonic saline solution

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

six

Details on study design:

TEST SITE
- Area of exposure: 1 inch square
- Type of wrap if used: plastic


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing done
- Time after start of exposure:24 hours


SCORING SYSTEM: see table below

Red phosphorus is introduced under the 1X1 inch gauze patch. The gauze patch is pressed down firmly to assure uniform contact with the skin. The trunks of the animals are then securely wrapped with an impervious material plastic wrap) and the animals are placed in restaining collars.

Results and discussion

In vivo

Results

Basis:

mean

Time point:

other: 24 and 72h

Score:

0

Max. score:

4

Reversibility:

other: n.a.

Remarks on result:

other: the test material does not have irritation potential

Irritant / corrosive response data:

The test material does not have irritation potential

Other effects:

Clinical signs indicative of systemic toxicity were not observed during the course of this study.

Any other information on results incl. tables

	Erythema and Eschar Formation				Edema Formation
Rabbit	Intact Skin		Abraded Skin		Intact Skin		Abraded Skin
number	24hr	72hr	24hr	72hr	24hr	72hr	24hr	72hr
2354D	0	0	1	0	0	0	1	0
2355D	0	0	1	0	0	0	1	0
2356D	0	0	1	0	0	0	0	0
2357D	0	0	1	0	0	0	0	0
2358D	0	0	1	0	0	0	0	0
2359D	0	0	1	0	0	0	0	0
Mean	0	0	1	0	0	0	0,3	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material does not have irritation potential

Executive summary:

Application of 0,5 g of oiled Red Phosphorus to intact and abraded skin of 6 New Zealand White rabbits for 24 hours did not produce signs of irritation. The mean primary irritation score (intact akin) was 0 which indicates that the test material does not have irritation potential. Clinical signs indicative of systemic toxicity were not observed during the course of this study.