Registration Dossier
Registration Dossier
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EC number: 500-457-0 | CAS number: 160901-19-9 1 - 2.5 moles ethoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- 6 animals used instead of 3, occlusive test conditions, no stepwise testing performed, results of first reading 30-60 min after patch removal not reported
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Alcohols, C12-13, branched and linear, ethoxylated
- EC Number:
- 500-457-0
- EC Name:
- Alcohols, C12-13, branched and linear, ethoxylated
- Cas Number:
- 160901-19-9
- Molecular formula:
- not applicable; UVCB
- IUPAC Name:
- Alcohols, C12-13, branched and linear, ethoxylated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding center Padre Antonio, Italy
- Weight at study initiation: 2 - 3 kg
- Housing: Stainless steel cages
- Diet: Pelleted complete diet (Nossan, Milano, Italy), ad libitum
- Water: Tap water from the local network, filtered with Seitz filter, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:approximately 6 square centimeters on the back of the animals
- Type of wrap if used: The test item was applied to a sterile gauze patch (hydrophilic, 12 layers surgial gauze, 2.5 x 2.5 cm). The impregnated gauze patch was kept in contact with the skin and secured in place by a thin band of adhesive hypoallergenic tape, 10 cm wide. The entire trunk was wrapped with rubberised cloth (Acrylastic Beyersdorf AG, Hamburg, Germany)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After patch removal, the test substance was cleaned out with water or an appropriate solvent.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS: 30 - 60 min, 24, 48, 72 h and 5 and 7 days
SCORING SYSTEM: Draize scoring scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- In 3/6 rabbits, very slight erythema (score 1) was observed at the 24 and 48 h reading. At the 72 h reading, there were no skin reactions observed in any animal. Oedema was not observed in any of the treated animals at any reading time point.
Any other information on results incl. tables
Table 1: Erythema scores observed in the individual animals
| Animal | 24 h | 48 h | 72 h | 5 days | 7 days | Mean 24/48/72 h |
| 1 | 1 | 1 | 0 | 0 | 0 | 0.67 |
| 2 | 1 | 1 | 0 | 0 | 0 | 0.67 |
| 3 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 4 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 5 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 6 | 1 | 1 | 0 | 0 | 0 | 0.67 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The test substance did not induce skin irritation in an in vivo study according to OECD guideline 404.
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