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EC number: 221-573-5 | CAS number: 3147-75-9
Toxicological information
Skin sensitisation
Currently viewing:
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 study, 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:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed, the LLNA did yet exist as an OECD guideline.
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol
- EC Number:
- 221-573-5
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol
- Cas Number:
- 3147-75-9
- Molecular formula:
- C20H25N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol
- Test material form:
- solid
- Details on test material:
- - Name of test substance (as cited in study report): Tinuvin 329
- Analytical purity: >99%
- Batch No.: EN 171744.92
- Physical state: solid
- Storage conditions: room temperature
- Validity: November 1993
Constituent 1
- Specific details on test material used for the study:
- - Name of test substance (as cited in study report): Tinuvin 329
- Analytical purity: >99%
- Batch No.: EN 171744.92
- Physical state: solid
- Storage conditions: room temperature
- Validity: November 1993
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, 4332 Stein, Switzerland
- Weight at study initiation (range): 351 g - 433 g
- Housing: individually in Makrolon cages (type 3)
- Diet: standard guinea pig pellets (NAFAG No. 845, Gosau SG); ad libitum
- Water: ad libitum
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- 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: oleum arachidis (intradermal) and vaseline (epidermal)
- Concentration / amount:
- Induction, intradermal: 5% in oleum arachidis
Induction, epidermal: 30% in vaseline
Challenge, epidermal: 10% in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: oleum arachidis (intradermal) and vaseline (epidermal)
- Concentration / amount:
- Induction, intradermal: 5% in oleum arachidis
Induction, epidermal: 30% in vaseline
Challenge, epidermal: 10% in vaseline
- No. of animals per dose:
- - Test group: 10 males and 10 females
- Control group: 5 males and 5 females - Details on study design:
- RANGE FINDING TESTS:
To identify irritant concentrations of the test substance a preliminary study was performed to select suitable, non-irritant concetration for the main study.
- Intradermal: 1% and 5% were tested and both were well tolerated
- Epidermal: 1, 5, 10 and 30% were tested and none of them induced erythema reactions
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: one intradermal application (3 pairs of intradermal injections (each 0.1 mL) were made simultaneously into the shaved neck of the guinea pigs)
- Test groups: intradermal: 1) adjuvant/saline mixture 1:1 (v/v), 2) test article in oleum arachidis (w/v), 3) test article in the adjuvant saline mixture (w/v);
- Control group: same treatment as test group only with adjuvant and vehicle
- Site: neck region
- Concentrations: intradermal: 5%
Epidermal:
- Test group: epidermal: closed patch exposure over the injection sites (test substance in vaseline, 2 x 4 cm², ca. 0.4 g paste per patch)
- Control groups: same treatment as test group only with adjuvant and vehicle
- Concentrations: 30% in vaseline
- Duration of exposure: 48 h
- Schedule: one week after intradermal induction (week 2)
week 3 and 4: no treatment
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day of challenge: day 29 (4 weeks after study initiation)
- Exposure period:24 h
- Test groups: the animals were tested with the test article in vaseline and the vehicle alone (patch 2 x 2 cm², 0.2 g paste per patch, occluded administration).
- Control group: The control group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 h and 48 h after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
OTHER:
The sesitivity of the strain is checked every six months with a known sensitiser, such as 2,4-dinitrochlorobenzene, para-phenylene-diamine or potasium-dichromate.
The body weight was recorded at start and end of the test. - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene, para-phenylene-diamine or potassium-dichromate.
Results and discussion
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:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Any other information on results incl. tables
Mean body weight (study initiation; study termination):
- Test group: males: 382 g; 602 g; females: 375 g; 564 g
- Control group: males: 383 g; 629 g; females: 377 g; 569 g
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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