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EC number: 235-826-2 | CAS number: 12788-93-1
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Irritation / corrosion
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Endpoint summary
Administrative data
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
- 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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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