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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1985-03-11 to 1985-03-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adults (5 males and 1 female)
- Housing:Individually housed
- Cage: suspended, stainless steel
- Diet (e.g. ad libitum): Lab rabbit chow HF (Purine #5326)
- Water (e.g. ad libitum): Automatic watering system Municipal water supply (Elizabeth town water Co)
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 °C - 21.1 °C (60 - 70 °F)
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12h / 12h

IN-LIFE DATES: From: To: 1985-03-26 to 1985-03-29
Type of coverage:
semiocclusive
Preparation of test site:
other: Clipped and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Approximately 24h
Observation period:
72h
Number of animals:
6 (5 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: back (between scapular and lumbar region)
- % coverage: 2.54 cm² (1 x 1 inch)
- Type of wrap if used: Plastic sheeting was wrapped around the animal and secured with tape. Plastic sheeting was then wrapped around the animal and secured with tape to retard evaporation an keep the test substance in contact with the skin without undue pressure. Elizabethan collars were then placed on the animals to prevent disruption of the wrappings and ingestion of the test material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently wiped free of excess test material with a paper towel and water.
- Time after start of exposure: 24h

OBSERVATION TIME POINTS
30 minutes after removal of wrappings and 72h after initiation of the treatment

SCORING SYSTEM:
- Method of calculation:
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/72h
Score:
6.3
Max. score:
8
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
3.7
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
2.8
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2.1
Max. score:
4
Reversibility:
not specified

Individual dermal irritation scores – 24h and 72h

Time

Sites

Type

6443 M

6444 F

6469 M

6453 M

6445 M

6451 M

Mean score

24h

Right side

(non-abraded)

Erythema

4S

4S

4S

3

3

4S

3.7

Edema

3

3

3

2

3

3

2.8

Left side

(Abraded)

Erythema

4S

4S

4S

3

3

4S

3.7

Edema

3

4

3

2

2

3

2.8

72h

Right side

(non-abraded)

Erythema

4N

4N

4N

4N

4N

4N

4.0

Edema

2

2

2

2

2

2

2.0

Left side

(Abraded)

Erythema

4

4N

4N

4N

4N

4N

4.0

Edema

2

2

2

2

2

3

2.2

 

Total

25.2

 

PDII

6.3

 N : Necrosis

S : Superficial necrosis

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance was corrosive to the skin. At 24h, four of six animals had superficial necrosis with moderate or severe edema at both the intact and abraded sites and two had mederate to severe erythema and edema. By 72h, all six animal had necrosis et the intact and/or abraded sites.
The primary Iirritation Index is 6.3
Executive summary:

In an in vivo skin corrosion study on rabbits, 0.5 mL of trioctylphosphine was applied on intact or abraded skin of rabbit.

Observations at 24h and 72h after application showed edema, erythema and necrosis.

A PDII was calculated to be 6.3.

The substance was considered to be corrosive to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-03-11 to 1985-05-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton-Dutchland, Inc. Denver, Pennsyvania
- Age at study initiation: Young adults
- Housing: Individually housed
- Cages: Suspended, stainless steel
- Diet (e.g. ad libitum): Lab Rabbit Chow HF (Purina #5326)
- Water (e.g. ad libitum): Automatic watering system Municipal water supply (Elyzabethtown water Co.)
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 to 21.1 °C (60 - 70 °F)
- Humidity (%):30 - 70 %
- Photoperiod (hrs dark / hrs light): 12h / 12h

IN-LIFE DATES: From: To:1985-05-26 to 1985-05-29
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 mL
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6 (2 males and 4 females)
Details on study design:
SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: fluorescein dye was used to confirm presence of absence of corneal ulceration.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #1
Time point:
24 h
Score:
10
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #2
Time point:
24 h
Score:
10
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #3
Time point:
24 h
Score:
8
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #4
Time point:
24 h
Score:
10
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #5
Time point:
24 h
Score:
12
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #6
Time point:
24 h
Score:
12
Max. score:
110
Reversibility:
not specified

Summary of responses and maximum Draize Scores

 

Animal number

Cornea

Iris

Conjunctivae

Score

First time obtained

Time clearb

 

Opacity

Ulceration

 

Redness

Chemosis

Necrosis or Ulceration

 

 

 

6422 F

-

-

-

-

+

-

10

24h

C

6423 M

-

-

-

-

+

-

10

24h

C

6424 F

-

-

-

-

-

-

8

24h

C

6426 F

-

-

-

-

+

-

10

24h

C

6427 M

-

-

-

+

+

-

12

24h

C

6406 F

-

-

-

+

+

-

12

24h

C

b : time clear is time that eye was free of all irritation

C: Not clear at termination of study (Day 3)

M: male

F: female

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance produced generally mild irritation which consisted primarilly of conjunctival redness, chemosis and discharge, with the most severe effects occuring at 24h. In five o the six animals, scores fo conjunctival chemosis and/or redness were considered positive irritant response. No corneal ulceration or opacity or iridial damage were seen. Periorbital irritaion (erythema, chemosis, alopecia, necrosis and:or desquamation) was evident in all six animals. Irritation persisted through study termination (72h), although some recovery from the 24-hour observations was apparent.
Executive summary:

In an in vivo eye irritation study, 0.1 mL of trioctylphosphine was applied into eye of rabbit.

Observations at 24h, 48h and 72h after application showed effects on Conjuntivae and Cornea.

Taking into accoun t thereulsts, the substance was considered to be irritating to the eye.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

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