Registration Dossier
Registration Dossier
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EC number: 272-037-2 | CAS number: 68649-89-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact Allergy due to Colophony. (VI). The Sensitizing Capacity of Minor Resin Acids and 7 Commercial Modified-colophony Products
- Author:
- Hausen BM; Hessling C
- Year:
- 1 990
- Bibliographic source:
- Contact Dermatitis, Vol. 23, No. 2, pages 90-95, 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of Pimaric acid was performed in guinea pig by using modified Freud’s completed adjuvant method
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Pimaric acid
- Cas Number:
- 127-27-5
- Molecular formula:
- C20H30O2
- IUPAC Name:
- Pimaric acid
- Details on test material:
- - Name of test material (as cited in study report): Pimaric acid
- Molecular formula : C20H30O2
- Molecular weight :302.455g/mole
- Substance type: organic
- Physical state: solid
- Purity: 90-95%
- Impurities (identity and concentrations):10-5%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Pimaric acid
- Molecular formula : C20H30O2
- Molecular weight :302.455g/mole
- Substance type: organic
- Physical state: solid
- Purity: 90-95%
- Impurities (identity and concentrations):10-5%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Remarks:
- Albino
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 00.1-0.15ml emulation of 4ml phys. Saline and 4 ml FCA in which 15mg of test material (10%)
- Day(s)/duration:
- 9
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- physiological saline
- Concentration / amount:
- 10%
- No. of animals per dose:
- 10 female
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: Semicircular arc on the Clipped and shaved shoulder area (4x6 cm).from left to right
- Frequency of applications: on days 1,5 and 9
- Duration: 9 days
- Concentrations: 00.1-0.15ml emulation of 4ml phys. Saline and 4 ml FCA in which 15mg of test material (10%)
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on day 20
- Exposure period: 24hr
- Test groups:10
- Control group: No data available
- Site: right shaved flank
- Concentrations:0.05ml of 10% test material
- Evaluation (hr after challenge): 24,48 and 72hr - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- The mean response was computed as the quotient of the sum of all reactions obtain, divided by the total number of treated animals
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization effect was observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- only 1 animals showed positive skin reaction
- Remarks on result:
- other: only 1 animals showed positive skin reaction
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization effect was observed
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No indication of skin sensitization after the 24 and 72hr in any of the 10 animals only 1 animals show positive skin sensitization effect 48 hr after challenge application
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Sensitizing
- Conclusions:
- The Pimaric acid (127-27-5) was considered to be not skin sensitizing in guinea pig.
- Executive summary:
The skin sensitization study of Pimaric acid (127-27-5)was performed by modified Freud’s completed adjuvant method in 10 female Pirbright white albino guinea pigs. In induction phase, intradermal injection of00.1-0.15ml emulation of 4ml phys. Saline and 4 ml FCA in which 15mg of test material (10%) concentration was given as semicircular arc on the Clipped and shaved shoulder area (4x6 cm).from left to right on day 1, 5 and 9. After rest period of 11 days, on day 20 Challenge given by using 0.05ml of 10% test material dose concentration applied open epicutaneous on right shaved flank. The reaction evaluated after 24,48 and 72hr.The mean response was computed as the quotient of the sum of all reactions obtain, divided by the total number of treated animals.No indication of skin sensitization after the 24 and 72hr in any of the 10 animals only 1 animals show positive skin sensitization effect 48 hr after challenge application. Hence the Pimaric acid (127-27-5) was considered to be not skin sensitizing in guinea pig
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