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EC number: 292-962-5 | CAS number: 91031-58-2
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:
- 23 Jan - 27 Jan 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropyl isodecanoate
- EC Number:
- 269-023-3
- EC Name:
- Isopropyl isodecanoate
- Cas Number:
- 68171-33-5
- IUPAC Name:
- 68171-33-5
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: very light yellow liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Des Feuilletas (40 - Campet Lamolere)
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm) with a grid floor
- Diet: food (UAR 112) ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod: 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites treated with 0.5 mL water under similar conditions as for the substance-treated site.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
Reading time points: 1 hour after the removal of the dressing and 24, 48 and 72 hours after application - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: The test substance was applied on a Codex hydrophilic eight layer gauze. The gauzes were kept into contact with the skin, using a hypoallergenic microporous adhesive strip of 50 mm wide. The wole was covered with a stretchable band (fixed with adhesive tape) wraped round the animal without any restraint for the respiratory and abdominal movements.
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 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritant / corrosive response data:
- Very slight erythema was observed in all 3 animals at reading time point 1 and persisted in one case until 24 h. The effect was fully reversible within 48 hours. Very slight edema was seen in one animal at reading time point 1 h, which however was no more evident at 24 h.
- Other effects:
- None
Any other information on results incl. tables
Table 1: Individual skin examination scores (Scoring according to Draize scheme)
Skin effect |
Erythema |
Edema |
||||||||
Scoring |
1h |
24h |
48h |
72h |
Meana |
1h |
24h |
48h |
72h |
Meana |
Animal No. #1 |
1 |
1 |
0 |
0 |
0.33 |
1 |
0 |
0 |
0 |
0 |
#2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
#3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
aMean of 24, 48 and 72 h scores
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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