Registration Dossier
Registration Dossier
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EC number: 629-661-9 | CAS number: 83834-59-7
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: Non-GLP study, deviations to current testing protocols
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FED. REG. 38, NO. 187, SECTION 1500.41 P. 27019, SEPT. 27, 1973
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester
- IUPAC Name:
- 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester
- Reference substance name:
- 2-ethylhexyl 4-methoxycinnamate
- EC Number:
- 226-775-7
- EC Name:
- 2-ethylhexyl 4-methoxycinnamate
- Cas Number:
- 83834-59-7
- Molecular formula:
- C18H26O3
- IUPAC Name:
- 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester, (2E)-
- Details on test material:
- - Name of test material (as cited in study report): Lusantan MCE
- Physical state: oily liquid
- Analytical purity: approx. 100%
- Lot/batch No.: 84/127
- Expiration date of the lot/batch: > 2 years
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER; D-6050 Offenbach/Main, Germany
- Weight at study initiation: 2,45; 2.46; 2.89; 2.88; 3.21; 2.98 (kg)
- Housing: cage made of stainless steel with wire mesh walk floors, floor area: 40 cm X 51 cm, No. of animals per cage: 1; No bedding in the cages; Sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study: same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 - 18.00 h/18.00 - 6.00 h)
IN-LIFE DATES: From: 28.01.1985 To: 12.02.1985
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipping of fur
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of test substance on a 2.5 cm X 2.5 cm patch - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 30 - 60 min, 24 h, 48 h, 72 h, 8 d, 15 d
- Number of animals:
- 6 (5 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
EVALUATION OF ERYTHEMA AND EDEMA:
0 = NONE
1 = YERY SLIGHT
2 = WELL-DEFINED
3 = MODERATE TO SEVERE
4 = SEVERE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Scaling observed in 1/6 animals, fully reversible within 15 days
Any other information on results incl. tables
| Readings | Animal | Erythema | Edema | Further findings |
| 24 h | 1 | 2 | 1 | |
| 2 | 2 | 0 | ||
| 3 | 2 | 1 | ||
| 4 | 2 | 1 | R:E | |
| 5 | 2 | 0 | ||
| 6 | 2 | 1 | ||
| 48 h | 1 | 1 | 0 | |
| 2 | 1 | 0 | ||
| 3 | 2 | 0 | ||
| 4 | 2 | 0 | R:E | |
| 5 | 1 | 0 | ||
| 6 | 2 | 0 | ||
| 72 h | 1 | 1 | 0 | |
| 2 | 1 | 0 | ||
| 3 | 2 | 0 | ||
| 4 | 2 | 0 | R:E | |
| 5 | 1 | 0 | ||
| 6 | 2 | 0 | ||
| 8 d | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 1 | 0 | S | |
| 5 | 1 | 0 | ||
| 6 | 0 | 0 | ||
| 15 d | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| 5 | 0 | 0 | ||
| 6 | 0 | 0 | ||
| Mean (24 h - 72 h) | 1 | 1.3 | 0.3 | |
| 2 | 1.3 | 0.0 | ||
| 3 | 2.0 | 0.3 | ||
| 4 | 2.0 | 0.3 | ||
| 5 | 1.3 | 0.0 | ||
| 6 | 2.0 | 0.3 | ||
| Mean (24 h - 72 h) | all animals | 1.7 | 0.2 |
R:E = Erythema, extending beyond the area of exposure S = Scaling. Similar findings after application on abraded skin with mean (24 h - 72 h) erythema/edema score (all animals): 1.7/0.3 (not relevant for assessment). Findings 30 - 60 min after patch removal were not reported.
Applicant's summary and conclusion
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