Registration Dossier
Registration Dossier
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EC number: 200-659-6 | CAS number: 67-56-1
Endpoint summary
Administrative data
Description of key information
A guinea pig maximization assay gave no evidence of contact sensitization after induction and challenge doses of 50%.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- comparable to guideline study with acceptable restrictions
- 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 Guinea Pig Maximazitation Test (1979) met the previous requirements before the entry into force of REACH. The GPMT is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
- 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 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 50%
- 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
- Positive control results:
- Positive controls not performed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: 1st study test group
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- slight erythema (score 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: 1st study test group. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: slight erythema (score 1).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: 1st study test group
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: 1st study test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: 1st study test group
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: 1st study test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: 2nd study test group
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- slight erythema (score 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: 2nd study test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 12.0. Clinical observations: slight erythema (score 1).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: 2nd study test group
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- slight erythemy (score 1)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: 2nd study test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 12.0. Clinical observations: slight erythemy (score 1).
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: 2nd study test group
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: 2nd study test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a guinea pig maximization assay conducted by BASF (1979a), 3/10 females exhibited a slight skin response (erythema score 1) 24 h after induction and challenge with a 50% aqueous methanol solution (0.1 mL), which can be interpreted as weak sensitizing potential. In another BASF study (1979b) 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 also be interpreted as a weak sensitising potential. The intracutaneous 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.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
not required
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The
low number of 4/22 animals with slight erythema (score 1) gives no
evidence of a notable sensitisation potential of methanol.
As
a result the substance is not considered to be classified for skin
sensitisation under Regulation (EC) No 1272/2008, as amended for the
tenth time in Regulation (EU) No 2017/776.
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