Registration Dossier
Registration Dossier
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EC number: 407-000-3 | CAS number: 127519-17-9 CGL 384; TINUVIN 384
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 24, 1990 - April 12, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC (September 19, 1984), Mutagenicity (Micronucleus Test). Official Journal of the European Communities No L 251 137-139.
- GLP compliance:
- yes
- Remarks:
- Genetic Toxicology CIBA-GEIGY Limited Basle, Switzerland
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
- EC Number:
- 407-000-3
- EC Name:
- A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
- Cas Number:
- 127519-17-9
- Molecular formula:
- C27 H37 N3 O3
- IUPAC Name:
- heptyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; nonyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; octyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
- Details on test material:
- - Physical state: liquid, viscouse
- Analytical purity: 98%
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: (Tif: MAGf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy animal farm
- Age at study initiation: young adult
- Weight at study initiation: Females: 22-33 g, Males: 24-32 g
- Housing: 2/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 41-52
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Vehicle:
- - Vehicle(s)/solvent(s) used: arachis oil
- Concentration of test material in vehicle: 500 mg/mL - Details on exposure:
- 10 mL/kg intraperitoneal with test substance and negative control
- Duration of treatment / exposure:
- 16, 24, 48 hours
- Frequency of treatment:
- once
- Post exposure period:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: oral: gavage
- Doses / concentrations: 64 mg/kg (20mL/kg)
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: range finding study up to 5000 mg/kg
TREATMENT AND SAMPLING TIMES
test substance: 16, 24, 48 hours
positive control: 24 hours
negative control: 16, 24, 48 hours
DETAILS OF SLIDE PREPARATION: After air-drying, the slides were stained with May-Grünwald/Giemsa solution and mounted. - Evaluation criteria:
- Criteria for a negative effect:
The test substance is considered to be inactive in this test system if in the groups treated with the test substance the number of micronucleated PCEs does not differ statistically significant from the number of the respective negative control or does not exceed the range accepted for the negative control (< 0.20 % ).
Criteria for a positive effect:
The test substance is considered to be active in this test system if at any group treated with the test substance the mean number of micronucleated PCEs exceeds the value of 0.20% and there is a statistically significant difference of the number of micronucleated PCEs in comparison with the negative control. If the positive effect occurs in a minority of the treated animals only and their number of micronucleated normochromatic erythrocytes
(NCEs) is enhanced in comparison with the respective negative control too, the effect on PCEs is not attributed to the treatment.
In extreme cases, if the limits of the criteria for a positive or for a negative response are reached, the Study Director will additionally interpret the results based on previous experience with this test system. - Statistics:
- The significance of differences was assessed by the Chi-Squaretest (p<0.05).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 5000, 1000, 200 mg/kg
- Clinical signs of toxicity in test animals: one animal died (The death of one female animal in the 48 hours dosage group is considered to be due to mismanipulation rather than to a doserelated effect.)
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no
- Ratio of PCE/NCE (for Micronucleus assay): see table below
The mean percentage of micronucleated PCEs was 0.09 (16 h) , 0.02 (24 h) and 0.02 (48 h).
In the positive control the percentage of micronucleated cells within polychromatic erythrocytes was increased. The mean percentage of micronucleated PCEs was 1.32. In comparison with the negative control (0.01 %) this value is significant (p<0.05).
Any other information on results incl. tables
| Exposure | Treatment | Sex | PCEs per 1000 erythrocytes (mean) |
Ratio of POE/NCE (mean) |
Micronucleated PCEs found in 5000 PCEs |
Percentage of micronucleated PCEs |
| 16 h | negative control | female | 461.00 | 0.90 | 7.00 | 0.14 |
| male | 332.00 | 0.50 | 1.00 | 0.02 | ||
| 5000 mg/kg | female | 406.00 | 0.70 | 6.00 | 0.12 | |
| male | 381.00 | 0.60 | 3.00 | 0.06 | ||
| 24 h | negative control | female | 437.00 | 0.80 | 0.00 | 0.00 |
| male | 365.00 | 0.60 | 1.00 | 0.02 | ||
| 5000 mg/kg | female | 360.00 | 0.60 | 1.00 | 0.02 | |
| male | 411.00 | 0.70 | 1.00 | 0.02 | ||
| positive control | female | 469.00 | 0.90 | 59.00 | 1.18 | |
| male | 436.00 | 0.80 | 73.00 | 1.46 | ||
| 48 h | negative control | female | 494.00 | 1.00 | 1.00 | 0.02 |
| male | 371.00 | 0.60 | 0.00 | 0.00 | ||
| 5000 mg/kg | female | 452.00 | 0.80 | 2.00 | 0.04 | |
| male | 419.00 | 0.70 | 0.00 | 0.00 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It is concluded that under the given experimental conditions no evidence for clastogenic or aneugenic effects was obtained in mice treated with the test substance. - Executive summary:
In a GLP-compliant mouse micronucleus test according to OECD guideline 474, groups of male and female Tif: MAGf (SPF) mice were treated once with the highest tolerated dose of test material, 5000 mg/kg (as determined in the tolerability test), and the appropriate treatment groups were sacrificed 16, 24 and 48 hours thereafter. Subsequently their femoral bone marrow erythrocytes were scored for micronuclei. In the dosage groups of 16 and 24 hours all animals survived the treatment. In the 48 hour dosage group one female died within the treatment period. At all sampling times (16, 24 and 48 hours) there was no statistically significant increase in the nvunber of micronucleated polychromatic erythrocytes in the animals treated with the dose of 5000 mg/kg of the test substance as compared with the negative control animals: the mean percentage of micronucleated PCEs was 0.09 (16 h) , 0.02 (24 h) and 0.02 (48 h). In the positive control the percentage of micronucleated cells within polychromatic erythrocytes was increased. The mean percentage
of micronucleated PCEs was 1.32. In comparison with the negative control (0.01 %) this value is significant (p<0.05). In conclusion, the evaluation of the bone marrow smears showed no statistically significant increase in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals at the respective sampling times. Under the given experimental conditions no evidence for clastogenic or aneugenic effects was obtained in mice treated with the test item.
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