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Description of key information

There are two studies available on the skin irritancy potential. Phosphoric acid, butyl ester was tested for its skin irritant properties in 1 White Russian rabbit. The study was performed according to OECD Guideline 404. Effects on the skin (erythema grades up to 4 and edema scores up to 4 as well as necrosis) were observed 1 hour after application. These signs were not reversible within 14 days.
In another study the test substance was applied undiluted or in dilutions (1:10, 1:100, 1:100000 and 1:1000000) to rabbit`s skin on 5 consecutive days. The undiluted dilution led to skin necrosis, the 1:10 dilution to reddening of skin.
According to EU regulation 1907/2006, Annex VII, column 2 an eye irritation study needs not to be conducted since Phosphoric acid, butyl ester is classified as corrosive to the skin.
Furthermore, there is one supporting study available on the eye irritancy potential. The application of a 1:100 or 1:1000 dilution of the test substance to the eyes of 3 rabbits leads to slight irritations. A treatment with a 2:100 dilution resulted in moderate eye irritation.

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:
7. Oct - 21. Oct 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline conform study with sufficient reporting.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
other: white Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2,3 kg
- Housing: individually in stainless seel cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen (Sniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/-5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 07.10. To: 21.10.1986
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
a. 60 min post applicationem
b. 24 h post applicationem
c. 48 h post applicationem
d. 72 h post applicationem
e. 6 d post applicationem
f .8 d post applicationem
g .10 d post applicationem
h .14 d post applicationem
Number of animals:
1; no further testing mandatory since the substance is corrosive
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: The treated area was covered with a gauze patch to prevent loss of test material. The test material and the gauze patch were covered with polyethylene foil and held in contact with the skin with a semi-occlusive patch adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was removed with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM:
Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: for animal welfare reasons only one test animal used
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: for animal welfare reasons only one test animal used
Irritant / corrosive response data:
Necrosis was reported from 1 h after application until study termination
Other effects:
no other effects reported
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Phosphoric acid, butyl ester was tested for its skin irritant properties in 1 White Russian rabbit. Effects on the skin (erythema grades up to 4 and edema scores up to 4 as well as necrosis) were observed 1 hour after application. These signs were not reversible within 14 days. herefore, Phosphoric acid, butyl ester has to be classified as corrosive to the skin (Causes severe skin burns and eye damage - H314) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Phosphoric acid, butyl ester was tested for its skin irritant properties in 1 White Russian rabbit. The study was performed according to OECD Guideline 404. Effects on the skin (erythema grades up to 4 and edema scores up to 4 as well as necrosis) were observed 1 hour after application. These signs were not reversible within 14 days. Therefore, Phosphoric acid, butyl ester has to be classified as corrosive to the skin (Causes severe skin burns and eye damage - H314) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: 2 studies available: corrosive

Eye irritation: 1 supporting study available: corrosive

 

There are two studies available on the skin irritancy potential. Phosphoric acid, butyl ester was tested for its skin irritant properties in 1 White Russian rabbit. The study was performed according to OECD Guideline 404. Effects on the skin (erythema grades up to 4 and edema scores up to 4 as well as necrosis) were observed 1 hour after application. These signs were not reversible within 14 days.
In another study the test substance was applied undiluted or in dilutions (1:10, 1:100, 1:100000 and 1:1000000) to rabbit`s skin on 5 consecutive days. The undiluted dilution led to skin necrosis, the 1:10 dilution to reddening of skin.

According to EU regulation 1907/2006, Annex VII, column 2 an eye irritation study needs not to be conducted since Phosphoric acid, butyl ester is classified as corrosive to the skin.
Furthermore, there is one supporting study available on the eye irritancy potential. The application of a 1:100 or 1:1000 dilution of the test substance to the eyes of 3 rabbits leads to slight irritations. A treatment with a 2:100 dilution resulted in moderate eye irritation.


Justification for selection of skin irritation / corrosion endpoint:
reliable study

Justification for selection of eye irritation endpoint:
n.a.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

With reference the reported the presence of necrotic skin Phosphoric acid, butyl ester has to be classified as corrosive to the skin (H314 – Causes severe skin burns and eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

It is concluded that the undiluted Phosphoric acid, butyl ester has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H314 - Causes severe skin burns and 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).

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