Registration Dossier

Administrative data

Description of key information

Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its skin irritant properties in 3 New Zealand White and 2 Himalayan rabbits. The studies were performed according to OECD Guideline 404. Effects on the skin (mean erythema grades up to 2.3 and mean edema scores up to 0.7) were observed in all animals 24 hours after application. These signs were reversible within the 21 days observation period. 
Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its eye irritant properties in 3 New Zealand White and 2 Himalyan rabbits. These studies were performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application. These signs were irreversible in all animals.

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:
Apr 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline conform study with restricted reporting
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
bw: 3.1 - 4.0 kg
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
30 - 60 min post application
24 hours post application
48 hours post application
72 hours post application
7 d post application
14 d post application
21 d post application
Number of animals:
3
Details on study design:
no data
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 14 days
Irritant / corrosive response data:
Mean erythema score (all animals): 2.2
Mean edema score (all animals): 0.6
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With reference the reported scores and the reported reversiblity within 21 days Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the skin (H 315: Causes skin irritation) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its skin irritant properties in 3 New Zealand rabbits. The study was performed according to OECD Guideline 404.

With reference the reported scores and the reported reversiblity within 21 days Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the skin (H 315: Causes skin irritation) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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:
Apr 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with restricted reporting.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand
Details on test animals or tissues and environmental conditions:
body weight: 2380 - 2980 g
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1 hour post application
24 hours post application
48 hours post application
72 hours post application
7 days post application
Number of animals or in vitro replicates:
3
Details on study design:
The eyes were examined 1, 24, 48 and 72 hours and 7 days after application of the test substance.
24 hours after treatment the eyes were washed out.

SCORING SYSTEM:

A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4


IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2


CONJUNCTIVAE

A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

B. Chemosis (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

C. Secretion
No secretion......................................................................................................................0
Any secretion above normal...........................................................................................1
Secretion with wetting of palpebra and hair close to palpebra.................................2
Secretion with wetting of palpebra, hair and considerable area around eyes........3

Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: examination not possible due to corneal opacity on day 7
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: examination not possible due to corneal opacity on day 7
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With reference the reported scores and the irreversibility of the observed effects Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the eyes (H 318: Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Reaction mass of potassium ethyl octyl phosphonate was tested for its eye irritant properties in 3 New Zealand rabbits.The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application. These signs were not reversible within 7 days.

With reference the reported scores and the irreversibility of the observed effects Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the eyes (H 318: Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: 1 key study and 1 supporting available: irritating

Eye irritation: 1 key study available: corrosive

 

There are one reliable study and one abstract available on the skin irritancy potential. Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its skin irritant properties in 3 New Zealand White and 2 Himalayan rabbits. The studies were performed according to OECD Guideline 404. Effects on the skin (mean erythema grades up to 2.3 and mean edema scores up to 0.7) were observed in all animals 24 hours after application. These signs were reversible within the 21 days observation period.

There are one reliable study and one abstract available on the eye irritancy potential. Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its eye irritant properties in 3 New Zealand White and 2 Himalyan rabbits. These studies were performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application. These signs were irreversible in all animals.


Justification for selection of skin irritation / corrosion endpoint:
Guideline conform study with restricted reporting

Justification for selection of eye irritation endpoint:
Guideline study with restricted reporting.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

With reference the reported scores and the reversibility of the observed effectsReaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonatehas to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation, skin irritant category 2) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

With reference the reported scores and the irreversibility of the observed effectsReaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonatehas to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).