Registration Dossier
Registration Dossier
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EC number: 204-068-4 | CAS number: 115-18-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-methylbut-3-en-2-ol
- EC Number:
- 204-068-4
- EC Name:
- 2-methylbut-3-en-2-ol
- Cas Number:
- 115-18-4
- Molecular formula:
- C5H10O
- IUPAC Name:
- 2-methylbut-3-en-2-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-methylbut-3-en-2-ol
- Substance number: 89/809
- Batch No.: Abl.-No. 79-1089
- Purity: 97.9 %
- Physical state: liquid, achromatic
- Storage conditions: room temperature
- Stability of test substance preparations: confirmed by analysis
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co . KG, D-4923 Extertal 1, FRG
- Strain: Pirbright White, Dunkin Hartley HOE DHPK [SPF-LAC] BÖ
- Weight at study initiation: 297 - 350 g
- Housing: 5 per cage in Makrolon, type IV cages
- Diet (e.g. ad libitum): Kliba 341 .4 mm (Kaninchen- Meerschweinchen-Haltungsdiaet; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland); ad libitum
- Water (e.g. ad libitum): tap water (about 2 g of ascorbic acid per 10 1 water was added to the drinking water twice a week); ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: olive oil DAB 9
- Concentration / amount:
- intradermal induction: 5%
epicutanous induction: 75%
challenge: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil DAB 9
- Concentration / amount:
- intradermal induction: 5%
epicutanous induction: 75%
challenge: 50%
- No. of animals per dose:
- test groups: 10
control group: 5 - Details on study design:
- RANGE FINDING TESTS:
- No. of exposures: 2 within 96 h
- Exposure period: 24 h
- Test groups: 4
- Site: flank, respective on the same area
- Evaluation (hr after challenge): about 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE- INTRADERMAL
Intradermal injections in groups of two per animal: front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1; middle row: 2 injections each of 0.1 mL of the test substance formulation; back row: 2 injections each of 0.1 mL Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) with test substance
- Test groups: 10 animals
- Control group: 5 animals
- Site: shoulder
- Concentrations: 5% olive oil DAB 8
B. INDUCTION EXPOSURE - EPICUTANOUS
- No. of exposures: 1
- Exposure period: 48 h
- Patch: 2 x 4 cm filter paper strips soaked with substance were applied to the the shoulder under an occlusive dressing
- Test groups: 10 animals
- Control group: 5 animals
- Site: shoulder, same area as in the case of the previous intradermal application
- Frequency of applications: one week after intradermal induction
- Concentrations: 75% in olive oil DAB 9
C. CHALLENGE EXPOSURE - EPICUTANOUS
- No. of exposures: 1
- Day(s) of challenge: 21 days after intradermal induction
- Exposure period: 24 h
- Test groups: 10 animals
- Control group: 5 animals
- Site: intact clipped flank
- Concentrations: 50% in olive oil DAB 9
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch - Challenge controls:
- Vehicle treated
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol; 1 % in ethanol
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- olive oil DAB 9
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: olive oil DAB 9. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: very slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Pretest:
In the preliminary test, the minimum irritant concentration was found to be a 75% test substance preparation in olive oil DAB 9 and the maximum non-irritant concentration at 50% test substance preparation in olive oil DAB 9.
Intradermal induction:
Readings after 24 h:
Treatment with adjuvant: animals showed distinct erythema and edema
Treatment with test substance: animals showed distinct erythema and slight
edema
Treatment with test substance and adjuvant: animals showed exhibited necrotic
skin changes in addition to distinct edema in almost all application
areas
Control with adjuvant: animals showed distinct erythema and edema
Control with vehicle: animals showed distinct erythema
Control with vehicle and adjuvant: animals showed distinct erythema and edema
Epicutanous induction:
Readings after 48 h
Treatment with test substance: necrotic skin changes in addition to distinct
edema were observed in the test animals.
Control with vehicle: animals exhibited incrustation partially open in addition
to distinct erythema and edema except of two animals which showed
incrustation in addition to distinct erythema and edema.
Challenge:
The number of animals with skin findings after the challenge (21 days after
intradermal induction) is summarized in the following table:
| Challenge | ||
| 50% TS in olive oil DAB9 | olive oil DAB9 | |
| Control group 1 | 0/5 | 0/5 |
| Control group 2* | no TS application | 2/5 |
| Test group | 0/10 | 2/10 |
*: Control group 2 that had been intended for a potential 2nd challenge was not needed, since a 2nd challenge was not necessary on the basis of the unambiguous results of the 1st challenge
The challenge with the 50 % test substance preparation in olive oil DAB 9 did not cause any skin reactions, neither in the test animals nor in the animals of control group.
Olive oil DAB 9 applied as a vehicle caused slight erythema in 2 of 10 test group animals and in 2 out of 5 animals of control group 2.
Conclusion:
Under these test conditions and following the results described above 2-Methylbuten-3-ol-2 does not have a skin sensitizing effect in the guinea pig.
Applicant's summary and conclusion
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