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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
1985
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

Constituent 1
Reference substance name:
2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester
IUPAC Name:
2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester
Constituent 2
Chemical structure
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



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