Registration Dossier
Registration Dossier
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EC number: 203-016-8 | CAS number: 102-24-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Induction phase comprised 1st and 2nd induction, each subdivided into intradermal and epidermal treatment with 1-week-intervals between each treatment.
- Principles of method if other than guideline:
- Study was performed as modification of the Magnusson-Kligman test before the actual guideline was adopted.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted prior to the development and adoption of the LLNA Test guideline
Test material
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- methanol
- Details on test material:
- - Name of test material (as cited in study report): methanol, substance no. 78/333
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Firma Hagemann, Lippische Versuchstierzucht, 4923 Extertal
- Weight at study initiation: 449 - 824 g
- Diet (e.g. ad libitum): Ssniff K, ad libitum
- Water (e.g. ad libitum): ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 50%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%
- No. of animals per dose:
- 1st study: 10 test, 5 control
2nd study: 12 test, 5 control - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: d 0 (1st intradermal), 7 (1st epicutaneous), 14 (2nd intradermal), 21 ( 2nd epicutaneous)
- Test groups: 1st intradermal: 6 parallel injections with Freund's adjuvant, 50% methanol and Freund's adjuvant + 50% methanol, respectively; 2nd intradermal: 4 parallel injections with 50% methanol and Freund's adjuvant + 50% methanol, respectively; both epidermal: conc. methanol
- Control group: no induction treatment
- Site: shoulder region
- Frequency of applications: weekly
- Duration: epicutaneous: 48 h occlusive
- Concentrations: 50% intradermal, 100% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 34 days after 1st intradermal induction
- Exposure period: 24 h occlusive
- Test groups: 1st study: right 50% methanol, left 25% formaldehyde epicutaneous; 2nd study: concentrated methanol epicutaneous
- Control group: 1st study: right 50% methanol, left 25% formaldehyde epicutaneous; 2nd study: concentrated methanol epicutaneous
- Site: flank
- Concentrations: 50% methanol and 25% formaldehyde, respectively (study 1), 100% methanol (study 2)
- Evaluation (hr after challenge): 24, 48 and 72 hours - Challenge controls:
- Control groups (no induction treatment)
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Positive controls not performed.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st reading; 1st group
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- slight erythema (score 1)
- Reading:
- other: 2nd reading ; 1st group
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- other: 3rd reading; 1st group
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 1st reading; 2nd group
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- slight erythema (score 1)
- Reading:
- other: 2nd reading; 2nd group
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- slight erythemy (score 1)
- Reading:
- other: 3rd reading; 2nd group
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: negative control
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: positive control
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- nil
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
In the first study, 3/10 females exhibited a slight skin response (erythema score 1) 24 h after challenge, in the parallel test with formaldehyde 1/10 females exhibited a slight skin response (erythema score 1) 24 h after challenge, which can be interpreted as weak sensitizing potential.
In the second study using 12 female animals at a concentration of 50 % methanol, 1/12 exhibited a slight skin response (erythema score 1) 24 and 48 h after challenge which can be interpreted as a weak sensitising potential.
The intracutane inductions produced necroses and some open ulcerations in both studies.
In summary, the low number of 4/22 animals with slight erythema (score 1) gives no evidence of a notable sensitisation potential of methanol.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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