Registration Dossier
Registration Dossier
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EC number: 606-441-0 | CAS number: 201305-16-0
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only study summary with limited information available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Gross- and histomorphological examination of rabbit skin for signs of comedogenicity after repeated dermal application of the test item.
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- not applicable
Test material
- Reference substance name:
- Benzoic acid, C12-15-alkyl esters
- EC Number:
- 270-112-4
- EC Name:
- Benzoic acid, C12-15-alkyl esters
- Cas Number:
- 68411-27-8
- IUPAC Name:
- 68411-27-8
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Analytical purity: no data
- Lot/batch No.: 25431
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No information provided in the summary report.
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: right ear
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): neat - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- 5 days per week, 3 consecutive weeks
- Post exposure period:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
neat test material
Basis:
- No. of animals per sex per dose:
- 3 animals (not further specified)
- Control animals:
- other: the left ears remained untreated and served as control
Examinations
- Examinations:
- Observations of grossly appearing enlarged pores and hyperkeratosis (comedones) were made daily. At study termination, biopsies were made of the ears, the slides were stained with H&E, and the extent of hyperkeratosis of sebaceous follicles was determined and compared to the control samples.
Results and discussion
- Details on results:
- Gross observation: Increasing pore size was noted.
Histological examination: Mild irritation was observed, but no changes relating to comedogenicity were noted.
Applicant's summary and conclusion
- Conclusions:
- This test article shows no evidence for comedogenic potential under the conditions of this test.
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