Registration Dossier
Registration Dossier
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EC number: 221-043-3 | CAS number: 2983-37-1
Specific investigations: other studies
Administrative data
- Endpoint:
- phototoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Ch. Gloxhuber, J. Soc. Cosmet. Chem., 27, 399 (1976)
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP
- Type of method:
- in vivo
- Endpoint addressed:
- skin irritation / corrosion
Test material
- Reference substance name:
- Ethyl 2-ethylhexanoate
- EC Number:
- 221-043-3
- EC Name:
- Ethyl 2-ethylhexanoate
- Cas Number:
- 2983-37-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- ethyl 2-ethylhexanoate
- Test material form:
- other: 5% solution in olive oil
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethyl-ethylcapronat
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: hairless (hr hr)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 25.2-26.6 g
- Fasting period before study: no
- Housing: individually in type 1 makrolon cages
- Diet (e.g. ad libitum): Altromin maintainance diet 1314, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 50
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- olive oil
- Details on exposure:
- TEST SITE
- Area of exposure: back, 2 x 1.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 drops per application
- Concentration (if solution): 5% - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 1 h
- Frequency of treatment:
- 2 applications: 1 h + 0.5 h before irradiation
- Post exposure period:
- 3 d
Doses / concentrations
- Dose / conc.:
- 0.5 other: %
- Remarks:
- Basis: nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- other: irradiation control (no test substance, only irradiation) + test substance control (only test substance, no irradiation)
Results and discussion
- Details on results:
- 6 h after treatment, skinfold thickness was increased by ca. 0.2 mm in animals treated with test substance -irradiation and animals treated with test substance +irradiation
After 30 h skinfold thickness was increased by 0.4 mm in animals treated with test substance -irradiation and animals treated with test substance +irradiation and by ca. 0.1 mm in animals only irradiated..
Body weight gain was normal in all groups. No clinical signs were observed.
Applicant's summary and conclusion
- Conclusions:
- 2-Ethyl ethyl capronate (5% in olive oil) was not phototoxic to hairless mice in this test.
- Executive summary:
In a phototoxicity study according to the method of Gloxhuber (Ch. Gloxhuber, J. Soc. Cosmet. Chem., 27, 399 (1976)), 2-Ethyl ethyl capronate (5% in olive oil) was applied to 2x1.5 cm on the back of 10 hairless mice in 2 applications (1 h + 0.5 h before irradiation; 2 drops per application) and irradiated with UV light for 2.5 min.
Animals treated with no test substance, only irradiation served as irradiation control; animals treated with only test substance, no irradiation served as test substance control. Skinfold thickness (edema) was measured after 6, 24, 30, 48, 54 and 72 h.
A substance is considered to be phototoxic when animals treated with the test substance + irradiation (=test group) show an increase in skinfold thickness and both control groups do not develop edema.
Skinfold thickness in the test group was comparable to the test substance control group. Skinfold thickness of test group and test substance control group was slightly higher than in the irradiation control group.
2-Ethyl ethyl capronate (5% in olive oil) was not phototoxic to hairless mice in this test.
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