Registration Dossier
Registration Dossier
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EC number: 291-445-1 | CAS number: 90411-68-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15 Oct 1991 - 29 Oct 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance Cetyl-2-Ethylhexanoate. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexadecyl 2-ethylhexanoate
- EC Number:
- 261-619-1
- EC Name:
- Hexadecyl 2-ethylhexanoate
- Cas Number:
- 59130-69-7
- Molecular formula:
- C24H48O2
- IUPAC Name:
- hexadecyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): cetyl-2-ethylhexanoate
- Physical state: colourless liquid
- Analytical purity: not given
- Lot/batch No.: 120300
- Expiration date: December 31st, 1991
- Storage: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2540 g
- Housing: individual
- Diet: Ssniff rabbit diet K4, Ssniff GmbH, Soest, Germany; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 1, 24, 48, 72 h and 7 and 14 days after exposure - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the left or right flank
- Type of wrap if used: gauze patch covered with an adhesive air- and vapor-permeable patch and fixed by using a hypoallergenic adhesive gauze-bandage.
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 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3 showed the same mean value for the 3 readings
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Table 1: Evaluation of the dermal reaction
Skin effect |
Erythema |
Edema |
||||||||
|
1h |
24h |
48h |
72h |
Meana |
1h |
24h |
48h |
72h |
Meana |
Animal No. #1 |
1 |
1 |
1 |
2 |
1.3 |
1 |
1 |
1 |
2 |
1.3 |
#2 |
1 |
1 |
2 |
2 |
1.7 |
1 |
1 |
1 |
2 |
1.3 |
#3 |
1 |
1 |
2 |
3 |
2.0 |
1 |
1 |
1 |
2 |
1.3 |
amean of readings at 24, 48 and 72 hours
Skin effect |
days after exposure |
|
|
7 |
14 |
Animal No. #1 |
i b S |
+ |
#2 |
i b S |
+ |
#3 |
i b S |
+ |
i = irreversible
b = brownish
S = eschar
+ = reversible
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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