Registration Dossier
Registration Dossier
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EC number: 202-676-4 | CAS number: 98-52-2
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:
- guideline study with acceptable restrictions
- Remarks:
- no data on positive control/strain sensitivity
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in May 1981
- Deviations:
- yes
- Remarks:
- (no data on positive control/strain sensitivity)
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted.
This test is considered appropriate and it is not justified to conduct an additional LLNA study due to animal welfare.
Test material
- Reference substance name:
- 4-tert-butylcyclohexanol
- EC Number:
- 202-676-4
- EC Name:
- 4-tert-butylcyclohexanol
- Cas Number:
- 98-52-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-tert-butylcyclohexan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino guinea pig, Bor:DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 359.1 g (test group), 378.9 g (control group)
- Housing: 1-5 animals/cage in Makrolon cages type IV
- Diet: G4 Alleindiaet fuer Meerschweinchen (Ssniff Spezialfutter GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 4-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 Mar 1988 To: 25 Mar 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5% in vehicle
epicutaneous induction: 100%
epicutaneous challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5% in vehicle
epicutaneous induction: 100%
epicutaneous challenge: 100%
- No. of animals per dose:
- test group: 20
control group: 10 - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections (0.1 mL)):
Injection 1: a 1:1 mixture Freunds complete adjuvant (FCA)/water
Injection 2: 5% test substance in corn oil
Injection 3: 5% test substance in a 1:1 mixture FCA/corn oil
Epicutaneous: 100% test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture Freunds complete adjuvant (FCA)/water
Injection 2: corn oil
Injection 3: a 1:1 mixture FCA/corn oil
Epicutaneous: corn oil
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 challenge
- Day of challenge: 21 (challenge)
- Exposure period: 24 h
- Test groups: 100% test substance
- Control group: 100% test substance
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h
OTHER: For the epicutaneous treatments, the test item was heated above the melting point to approx. 70 °C. The patches were soaked with the test substance and applied to the skin after cooling down. The patches were covered with a 6 x 6 cm² leukoflex-tape and fixed with an elastic bandage. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- substance residues in 4/20 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: substance residues in 4/20 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- substance residues in 1/20 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: substance residues in 1/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- substance residues in 6/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: substance residues in 6/10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- substance residues in 1/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: substance residues in 1/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Local findings
- after intradermal induction: pronounced erythema and edema including slight necrosis at the FCA/water injection sites (test and control group) and the FCA/vehicle injection site (control group); pronounced erythema and edema at the test item/vehicle injection site (test group); slight erythema and edema at the vehicle injection site (control group) and pronounced erythema and edema including pronounced necrosis at the test item/FCA/vehicle injection site (test group)
- after epicutaneous induction (48 h): bloody inflammation at all sites previously treated with FCA (test group and control group); encrustation after 24 h
Body weight
No effects on body weight gain was seen during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test item showed no sensitising potential in a guinea pig maximisation test.
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