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EC number: 306-084-8 | CAS number: 95912-88-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jun - 30 Jun 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. The exposure was done under occlusive conditions, few details on the test substance were given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- occlusive exposure, lack of details on test substance
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposure, lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, isotridecyl esters
- EC Number:
- 306-084-8
- EC Name:
- Fatty acids, C16-18, isotridecyl esters
- Cas Number:
- 95912-88-2
- Molecular formula:
- C29H58O2 and C31H62O2
- IUPAC Name:
- Fatty acids, C16-18, isotridecyl esters
- Details on test material:
- - Name of test material (as cited in study report): isotridecylstearate
- Physical state: colourless liquid
- Analytical purity: no data
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, Germany
- Weight at study initiation: 2442 g (average)
- Housing: single housing in rabbit cages, (Fa. Heinkel, Kuchen, Germany)
- Diet: feed 20 ZH 5 (Fa. Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-21
- Humidity (%): approximately 45-50
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin served as the 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:
- 7 days
Reading time points: 1, 24, 48 and 72 h, and 7 days - Number of animals:
- 5 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin, an approximately 2.5 cm x 2.5 cm area
- Type of wrap if used: a 2.5 cm x 2.5 cm gauze patch with the test substance was applied to the skin of the rabbit. The gauze patch was covered by a plastic film, which was fixed with adhesive tapes; then finally an acrylastic band (occlusive) was applied. During the 4-hour exposure the animals were kept in special boxes to ensure the wrapping did not move.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
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
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- 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 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- No irritation effects were observed 1 hour after exposure ended. At the 24-hour reading time point, 3/5 animals had very slight erythema and edema. By the 48-hour reading time point, the severity had increased to well-defined erythema in 2/5 animals, while 2/5 had very slight erythema. 2 of these rabbits also had very slight edema, which was still present at the 72-hour reading time point. Very slight to well-defined erythema persisted in 3/5 rabbits until 72 hours after exposure. All the irritation effects had cleared completely within 7 days.
Any other information on results incl. tables
Table 1: Individual skin irritation scores
Observation time |
Rabbit no. |
||||||||||||
1 |
2 |
3 |
4 |
5 |
|
||||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
|
||
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
24 h |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
|
|
|
48 h |
1 |
0 |
1 |
0 |
2 |
1 |
2 |
1 |
0 |
0 |
|
|
|
72 h |
1 |
0 |
0 |
0 |
1 |
1 |
2 |
1 |
0 |
0 |
|
|
|
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
Mean value 24 + 48 + 72 h |
1.00 |
0.33 |
0.33 |
0 |
1.33 |
1.00 |
1.67 |
1.00 |
0 |
0 |
|
|
|
Mean value 24 + 48 + 72 h all animals |
0.87 |
0.47 |
|
|
|
|
|
|
|
|
|
|
|
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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