Registration Dossier
Registration Dossier
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EC number: 485-270-1 | CAS number: -
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Feb 2007 (date of Project Protocol) - 11 April 2007 (date of Report)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 April, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- Colour: Light yellow
Constituent 1
- Specific details on test material used for the study:
- Storage conditions: at room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Animal 1: 2,9 kg; Animal 2: 2.3 kg; Animal 3: 3.0 kg
- Housing: Semi-barrier in an air conditioned room, ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free (TPF)
- Water: Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: adequate acclimatization period
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- rel. Humidity: 55 ± 10%
- Air changes: at least 10x / hour
- Photoperiod (hrs dark / hrs light): artificial light: 12 h light, 12 h dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Test item was applied to a small area of skin on one side of the dorsal area, the untreated other side served as control.
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Test item was applied to a small area (approx. 6 cm²) of skin on one side of the dorsal area
- Type of wrap if used: covered with a gauze patch, which was held in place with non-irritating tape.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after patch removal
SCORING SYSTEM:
For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 24, 48 and 72 hours after patch removal. Dermal irritation was scored and recorded according to grades of the classification system below:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef-redness) to eschar
formation preventing grading of erythema 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extending
beyond exposure area) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test item showed neither irritant nor corrosive effects on the intact skin of the three rabbits.
- Other effects:
- There were no significant body weight changes during the contact and observation period.
Any other information on results incl. tables
Body Weight
| Animal No. | Start of Study (Weight kg) | End of Study (Weight kg) |
| 1 | 2.9 | 3.0 |
| 2 | 2.3 | 2.4 |
| 3 | 3.0 | 3.1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vivo skin irritation test performed according to OECD/EC guidelines and GLP principles, the substance was concluded to be non-irritant to the skin.
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