Registration Dossier
Registration Dossier
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EC number: 285-503-5 | CAS number: 85114-00-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Existing in vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 June to 27 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD Guideline 404 (1992) and according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-hydroxypropyl 2-ethylhexanoate
- EC Number:
- 261-499-0
- EC Name:
- 2-hydroxypropyl 2-ethylhexanoate
- Cas Number:
- 58921-10-1
- Molecular formula:
- C11H22O3
- IUPAC Name:
- 2-hydroxypropyl 2-ethylhexanoate
- Reference substance name:
- 1-hydroxypropan-2-yl 2-ethylhexanoate
- Molecular formula:
- C11H22O3
- IUPAC Name:
- 1-hydroxypropan-2-yl 2-ethylhexanoate
- Reference substance name:
- Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
- IUPAC Name:
- Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
- Reference substance name:
- 1-methylethylene 2-ethylhexanoate
- EC Number:
- 301-185-3
- EC Name:
- 1-methylethylene 2-ethylhexanoate
- Cas Number:
- 93981-97-6
- Molecular formula:
- C19H36O4
- IUPAC Name:
- propane-1,2-diyl bis(2-ethylhexanoate)
- Reference substance name:
- 2-ethylhexanoic acid
- EC Number:
- 205-743-6
- EC Name:
- 2-ethylhexanoic acid
- Cas Number:
- 149-57-5
- Molecular formula:
- C8H16O2
- IUPAC Name:
- 2-ethylhexanoic acid
- Reference substance name:
- Propane-1,2-diol, propoxylated
- EC Number:
- 500-039-8
- EC Name:
- Propane-1,2-diol, propoxylated
- Cas Number:
- 25322-69-4
- IUPAC Name:
- Propane-1,2-diol, propoxylated
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (colourless, slightly viscous)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.62 to 2.73 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: elasticated corset (TUBIGRIP) wrapped around the trunk
REMOVAL OF TEST SUBSTANCE: yes, by gentle sawbbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize J.H. (1977)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h mean values
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 72, 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period.
- Other effects:
- No other effects were noted
Any other information on results incl. tables
More detailed irritation scoring can be found in the attached document below.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not a skin irritant.
- Executive summary:
In this dermal irritation study, 3 young adult New Zealand rabbits, 2 males and 1 female, were exposedviathe dermal route to 0.5 ml of SER-AD FX 511 per animal. The test material was applied as a aliquid for 4 hours to a 2.5x 2.5cm of the body surface area of test animals. Animals then were observed for 7 days. Irritation was scored using the Draize scheme. Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period. In this study, SER-AD FX 511 was not a dermal irritant. On the basis of this study, SER-AD FX 511 does not warrant classification as being irritating to the skin.
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