Registration Dossier
Registration Dossier
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EC number: 213-367-9 | CAS number: 939-97-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The test was performed in line with to the Draize test, Federal Register 38 (1973), No. 187, § 1500.41.
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-tert-butylbenzaldehyde
- EC Number:
- 213-367-9
- EC Name:
- 4-tert-butylbenzaldehyde
- Cas Number:
- 939-97-9
- Molecular formula:
- C11H14O
- IUPAC Name:
- 4-tert-butylbenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): p-tertiaerbutyl-benzaldehyde
- Analytical purity: 98 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Average weight at study initiation: males: 2.88 kg; female: 2.49 kg
- Diet: Ssniff (Intermast), ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated sites of the same animal served as control.
- Amount / concentration applied:
- Ca. 0.5 ml of the undiluted test material was applied onto the skin of the animals (application area ca. 2.5 cm x 2.5 cm)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- Skin reactions were recorded after 24, 48 and 72 h and after 8 d.
SCORING SYSTEM:
according to J .H . DRAIZE - APPRAISAL OF THE SAFETY OF CHEMICALS IN FOODS, DRUGS AND COSMETIC5 IN DERMAL TOXICITY P . 46 - 59, 1959. AUSTIN, TEXAS: ASSOCIATION OF FOOD AND DRUG OFFICIALS OF THE UNITED STATES, TEXAS, STATE DEPARTMENT OF HEALTH
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scale was seen on day 8
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scale was seen after 72 h and on day 8
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scale was seen after 72 h and on day 8
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Individual scores of the animals:
Erythema scores:
animal 1 animal 2 animal 3
-----------------------------------------------
24 h 1 2 2
48 h 1 1 1
72 h 1 1* 1*
8 d 0* 0* 0*
-----------------------------------------------
mean
24-72h 1 1.3 1.3
* desquamation
Edema scores:
animal 1 animal 2 animal 3
-----------------------------------------------
24 h 0 1 1
48 h 0 0 0
72 h 0 0* 0*
8 d 0* 0* 0*
-----------------------------------------------
mean
24-72h 0 0.3 0.3
* desquamation
Applicant's summary and conclusion
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