Registration Dossier
Registration Dossier
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EC number: 220-342-6 | CAS number: 2726-73-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octadecane-1,12-diol
- EC Number:
- 220-342-6
- EC Name:
- Octadecane-1,12-diol
- Cas Number:
- 2726-73-0
- Molecular formula:
- C18H38O2
- IUPAC Name:
- octadecane-1,12-diol
- Details on test material:
- - Name of test material (as cited in study report): Oxystearylalkohol
- Physical state: white flaky solid
- Lot/batch No.: SAT 90-178
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach/D
- Weight at study initiation: ca. 2750 g
- Age at study initiation: 14 months
- Housing: Individual housing in rabbit cages (Fa. Heinkel, 7343 Kuchen/D)
- Diet: Altromin-Haltungsdiät 2023 (Fa. Altromin GmbH, Lage/D),ad libitum
- Water: Tap water, ad libitum
- Acclimation period: for at least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 0.5 g (heated at 37°C) of the substance was applied on a gauze pad of about 6 cm2. The substance was evenly distributed. After positioning the water and air permeable adhesive gauze pad to the shaved dorsal skin it was fixated with a hypoallergenic bandage.
SCORING SYSTEM: As described in EU Method B4 and OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #2 and #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One animal showed weak to moderate erythema and weak edema until 72 hours after the end of exposure. Another animal only showed slight erythema up to 48 hours, and the third one was without any irritations on the application area. The reactions disappeared totally within 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the substance was considered to be not irritating to the skin.
- Executive summary:
The skin irritation test was performed according to OECD 404 and in compliance with GLP. In this study, three Kleinrusse, Chbb:HM rabbits were exposed to 0.5g test substance for 4 hours under semi-occlusive conditions. The effects were scored after 1, 24, 48 and 72 hours and the rabbits were observed for 7 days. The mean score of 24, 48 and 72 hours for erythema was 2.33, 0.66 and 0 for animal 1, 2 and 3, respectively. The mean score of 24, 48 and 72 hours for edema was 0.66, 0 and 0 for animal 1, 2 and 3, respectively. The reactions disappeared totally within 7 days. Under the conditions of this study the substance was considered to be not irritating to the skin.
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