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EC number: 931-038-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
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- Oxidation reduction potential
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 26 FEB 1985 to 5 MAR 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Baisc data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13
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:
- yes
- Remarks:
- : no substance composition or purity stated, no statement given concerning results for day 14 observation
- GLP compliance:
- yes
Test material
- Reference substance name:
- 112-44-7 + 19009-56-4
- IUPAC Name:
- 112-44-7 + 19009-56-4
- Reference substance name:
- n-Undecanal + 2-methyldecan-1-al
- IUPAC Name:
- n-Undecanal + 2-methyldecan-1-al
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: Rosemead Rabbits Limited, Lea Valley, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.43 kg
- Housing: suspended metal cage, individually
- Diet: standard laboratory diet (Rabbit Diet, A. W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-55
- Air changes (per hr): ~ 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked with lukewarm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to guideline OECD 404
READING TIMES: 1, 24, 48, 72 hours after removal of the patches, if irritation persisted further observations were made 7 days and 14 days following removal of the patches
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- : total scores for erythema and edema divided by 6
- Time point:
- other: 24 and 72 h
- Score:
- 5.5
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all three animals; individual scores per animal: 3/3/2.67
- Time point:
- other: 24-48-72 h
- Score:
- ca. 2.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: reactions were extending beyond the site of application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all three animals; individual scores per animal: 2/3.34/3.34
- Time point:
- other: 24-48-72 h
- Score:
- ca. 2.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: reactions were extending beyond the site of application
- Irritant / corrosive response data:
- Additionally to erythema and edema desquamation was seen in two animals at 72 h. At day 7 hyperkeratinization with some flaking from affected areas was also evident in all three animals.
Any other information on results incl. tables
Read-across justification: for details please see read-across report in IUCLID section 13
After patch removal:
- 1 h: very slight erythema (score 1/1/1) and very slight or slight edema (score 2/2/1), with reactions extending beyond application site
- 24 h: moderate erythema (score 3/3/3) and slight or severe edema (score 2/4/4), with reactions extending beyond application site
- 48 h: moderate erythema (score 3/3/3) and slight edema (score 2/2/2), with reactions extending beyond application site
- 72 h: well defined or moderate erythema (score 3/3/2) and slight edema (score 2/2/2), with reactions extending beyond application site and desquamation observed in 2 animals
- 7 days: very slight or well defined erythema (score 1/2/1) and very slight edema (score 1/1/1), with reactions extending beyond application site and hyperkeratinization with some flaking of affected areas in all animals
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test substance was irritating to the skin of rabbits.
- Executive summary:
3 New Zealand white rabbits were dermally exposed to the undiluted test substance (purity: not stated; 0.5 mL fluid were soaked into 6.25 cm² gauze patch) according to testing guideline OECD 404. After 4 h of semiocclusive exposure and at reading times 24, 48 and 72 hours after patch removal the test substance caused well-defined to severe erythema (mean score: 2.89; individual scores per animal: 3/3/2.67) and slight or severe edema (mean score: 2.89; individual scores per animal: 2/3.4/3.4). After 72 h two animals out of three showed desquamation, after 7 days all animals showed hyperkeratinization with some flaking from the affected areas. The test item thus revealed irritating effects.
This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity.
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