Registration Dossier
Registration Dossier
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EC number: 701-479-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-09-12 to 1994-10-20
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed prior to LLNA implementation.
Test material
- Reference substance name:
- C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol
- EC Number:
- 701-479-5
- Molecular formula:
- C42H82O7
- IUPAC Name:
- C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Hostacerin DGI; Synonym: Fettsaeurepolyglycerinester
- Physical state: Liquid, light yellow
- Lot/batch No.: E06 213955
- Expiration date of the lot/batch: End of August 1996
- Storage condition of test material: in the dark at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.5 mL
- Day(s)/duration:
- Test item applied three times (6 hour duration each), i.e. at day 1, day 8 and day 15
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 20% /0.5 mL
- Day(s)/duration:
- Day 29/6 hour dermal challenge followed by macroscopic assessment on day 30 and day 31
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest: 2 animals/dose concentration (i. e. 6 animals total)
Control group: 10 animals
Treatment group: 20 animals - Challenge controls:
- The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- aceton (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 % test item in Aceton
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- aceton (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 % test item in Aceton
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.
- Executive summary:
In order to test for possible skin sensitizing effects, the test substance was investigated in a guinea pig skin sensitization test according to Buehler. 20 Pirbright-White guinea pigs in the treatment group and 10 animals in the control group were used. Dermal induction was performed using 100 % test item. The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone. Under the test conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = %).
Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.
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