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Registration Dossier
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EC number: 417-790-1 | CAS number: 78418-01-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 october 1989 to 14 october 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study following OECD and EU guidelines, with minor deviations: no certificate of analysis and housing temperature
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No certificate of analysis, deviation in housing temperature
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 417-790-1
- EC Name:
- -
- Cas Number:
- 78418-01-6
- Molecular formula:
- C15H20O4
- IUPAC Name:
- 2-Hydroxy-5-(1-oxooctyl)benzoic acid
- Reference substance name:
- MEXORYL SAB
- IUPAC Name:
- MEXORYL SAB
- Details on test material:
- - Name of test material (as cited in study report): ER 195
- Physical state: white crystalline powder
- Lot/batch No.: DG6
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
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, U.K.
- Age at study initiation: approximately 12 weeks to 16 weeks old
- Weight at study initiation: 2.12 - 2.30 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet (Preston Farmers limited, New Leake, U.K.), ad libitum
- Water (e.g. ad libitum): normal drinking water, ad libitum
- Acclimation period: after a minimum acclimatisation period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 62-65
- Air changes (per hr): approximately 15 changes/h
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
IN-LIFE DATES: From: 11 October 1989 To 14 October 1989
Test system
- Type of coverage:
- other: elasticated corset
- Preparation of test site:
- other: clipped dorsal and flank area
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of distilled water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset (Tubigrip)
REMOVAL OF TEST SUBSTANCE
- Gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize J. H. scale (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation
- Other effects:
- No data
Any other information on results incl. tables
No data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was regarded as not irritating according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a primary dermal irritation GLP study performed according to OECD guideline 404, three young adult male White New-Zealand rabbits were dermally exposed to 0.5 g of ER 195 in 0.5 mL of distilled water for 4 hours to 6.25 cm² of clipped skin. Animals then were observed for 3 days. Irritation was scored by the method of Draize (1959).
There was no irritant effect at any observation time point. In this study, ER 195 is not a dermal irritant on male rabbits.
Under the test conditions, ER 195 is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
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