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Toxicological information

Skin irritation / corrosion

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphoric acid, butyl ester
EC Number:
235-826-2
EC Name:
Phosphoric acid, butyl ester
Cas Number:
12788-93-1
Molecular formula:
C4H11PO4
IUPAC Name:
Phosphoric acid, butyl ester
Test material form:
other: liqud
Details on test material:
clear liquid
densitiy: ca. 1130 kg/m3
melting point: < -10°C

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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).

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