Registration Dossier
Registration Dossier
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EC number: 284-716-0 | CAS number: 84962-20-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13. Dec - 19. Dec 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Knapsack-Reinigerkomponente GB
- IUPAC Name:
- Knapsack-Reinigerkomponente GB
- Test material form:
- other: liquid
- Details on test material:
- colorless liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, 76410 Saint Aubin les Elbeuf, France
- Weight at study initiation: 2483 g
- Housing: individually in polystyrene cages (0.35 x 0.55 x 0.32 m)
- Diet (e.g. ad libitum): pelleted Rabbit Diet SQC (Special Diets Services Ltd., Witham, Essex, G.B.), ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 30%
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- 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. 5 d post applicationem
f. 6 d post applicationem
g. 7 d post applicationem - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm(2)
- % coverage: 100 %
- Type of wrap if used:The treated area was covered with a hydrophilic gauze patch to prevent loss of test material. The test material and the gauze patch were held in contact with the skin with a semi-occlusive patch adhesive tape. The animals were maintained in restrainer cages for 15 min.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was removed with a gauze saturated with sterile pyrogen-free 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:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Other effects:
- no effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores and the reversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol has not to be classified as irritant to the skin 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:
Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol was tested for its skin irritant properties in 6 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Effects on the skin (erythema grades up to 2 and edema scores up to 2) were observed some animals 24 hours after application. These signs were fully reversible within the 7 days observation period.
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