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EC number: 287-039-9 | CAS number: 85408-76-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 04 - 07 Jan 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions (analytical purity of test substance was not specified).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- 163961-32-8
- Cas Number:
- 163961-32-8
- IUPAC Name:
- 163961-32-8
- Details on test material:
- - Name of test material: only trade name given
- Physical state: amber colored liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended matal cages
- Diet: ad libitum, certified rabbit diet (Code 5322, PMI Nutrition)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 24, 48 and 72 hours - 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: cotton gauze patch secured in position with surgical adhesive patch
REMOVAL OF TEST SUBSTANCE
- Washing: with cotton soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritant / corrosive response data:
- Well-defined erythema was noted at all treated skin sites one hour after patch removal regressing to very slight erythema at all treated skin sites at the 24 h observation and two treated skin sites at the 48 h observation.
Slight edema was noted at all treated skin sites one hour after patch removal regressing to very slight erythema at all treated skin sites at the 24 h observation. One treated skin site appeared normal at the 48 h observation and the two remaining treated skin sites appeared normal at 72 h.
Any other information on results incl. tables
Erythema Score
Animal Number |
24 h |
48 h |
72 h |
1 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
3 |
1 |
1 |
0 |
Edema Score
Animal Number |
24 h |
48 h |
72 h |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
3 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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