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Registration Dossier
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EC number: 249-694-9 | CAS number: 29556-33-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- The sensitizing capacity of coumarins (III)
- Author:
- B.M. HAUSEN AND M. Berger
- Year:
- 1 989
- Bibliographic source:
- Contact Dermatitis 21: 141-147,1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin irritation test was conducted on guinea pigs to determine the irritation potential of 7-Diethylamino-4-methylcoumarin (CAS No: 91-44-1)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 7-(diethylamino)-4-methyl-2-benzopyrone
- EC Number:
- 202-068-9
- EC Name:
- 7-(diethylamino)-4-methyl-2-benzopyrone
- Cas Number:
- 91-44-1
- Molecular formula:
- C14H17NO2
- IUPAC Name:
- 7-(diethylamino)-4-methyl-2H-chromen-2-one
- Test material form:
- other: off white crystalline solid
- Details on test material:
- - Name of test material (as cited in study report): 7-Diethylamino-4-methylcoumarin
- Molecular formula : C14H17NO2
- Molecular weight :231.2933 g/mol
.- Substance type: organic
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-Methyl-7-diethylaminocoumarin
Molecular formula: C12H13NO2
Molecular weight : 203.24 g/mol
Smiles notation : c12c(ccc(c1)N(CC)CC)c(cc(=O)o2)C
InChl : 1S/C14H17NO2/c1415(52)11671210(3)814(16)1713(12)911/h69H,45H2,13H3
Substance Type: Organic
Physical State: Solid
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright- White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Age at study initiation: No Data available
- Weight at study initiation:280-350 g
- Housing: animals were kept 3 to a cage
- Diet (e.g. ad libitum):altromin ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No Data available
Or Test Tissue
- Source: No Data available
- Type: No Data available
- Acclimation : No Data available
- Housing conditions No Data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-24⁰C
- Humidity (%):50-55%
- Air changes (per hr): No Data available
- Photoperiod (hrs dark / hrs light): Under artificial illumination for 10 hours a day
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: clipped or shaved
- Vehicle:
- other: FCA and Physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- 10%, 3% and 1 %
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hours
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: clipped or shaved shoulder area (4*6 cm)
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : The results were read 24 hours after challenge exposure with the test chemical
SCORING SYSTEM:
- Method of calculation:A (+) reaction was considered as threshold of irritation
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation observed
Any other information on results incl. tables
Table 1: Results of the study
Test chemical |
Concentration |
Irritation index |
7-diethylamino-4-methyl coumarin (coumarin 1) |
10% |
0.0 |
The mean irritation index is the average of 3 readings
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The mean irritation index of 7-Diethylamino-4-methylcoumarin was 0.0 after 24 hours.
Hence, the test material 7-Diethylamino-4-methylcoumarin (CAS No: 91-44-1) was considered to be not irritating to guinea pigs - Executive summary:
Skin irritation test was conducted on guinea pigs to determine the irritation potential of 7-Diethylamino-4-methylcoumarin (CAS No: 91-44-1) .
10 female Pirbright-White guinea pigs were treated with an emulsion prepared from FCA and physiological saline but without the test chemical and applied on a semicircular arc on the clipped or shaved shoulder area (4*6 cm) from left to right in such a way that whole emulsion was used up for the animals.1 day before the challenge exposure, teh guinea pigs were treated with 7-Diethylamino-4-methylcoumarin (CAS No: 91-44-1) by applying different concentrations of the test chemical (10%, 3% and 1%) to the right flank.The results of the challenge exposure were observed after 24 hours. A (+) reaction was considered as threshold of irritation.
The mean irritation index of 7-Diethylamino-4-methylcoumarin was 0.0 after 24 hours.
Hence, the test material 7-Diethylamino-4-methylcoumarin (CAS No: 91-44-1) wasconsidered to be not irritating to guinea pigs
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