Registration Dossier
Registration Dossier
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EC number: 203-972-6 | CAS number: 112-44-7
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: guideline study with acceptable restrictions
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:
- n-undecanal
- IUPAC Name:
- n-undecanal
- Reference substance name:
- 2-methyl decanal
- IUPAC Name:
- 2-methyl decanal
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): n/i-undecanal
- Substance type: colourless
- Physical state: liquid
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- No information on purity provided, but it can reasonably be assumed that the test substance has a typical composition of 67% n-undecanal and 31% iso-undecanal as the substance was produced under comparable conditions of todays substance.
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:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- 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
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) based on GHS criteria
- 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 the test substance caused well-defined to severe erythema (mean score: 2.89) and slight or severe edema (mean score: 2.44). 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 (Ruhrchemie AG/Safepharm, 1985).
This study was judged to be reliable with restrictions (RL2), due to missing information on substance composition or purity.
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