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EC number: 939-894-0 | CAS number: -
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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:
- 22 October 2014 to 18 December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Partially hydrogenated β-3,7,11-trimethyldodeca-1,3,6,10-tetraene, reaction products with linear C8-C16 alpha olefin, hydrogenated.
- EC Number:
- 939-894-0
- Molecular formula:
- Variable - substance is a UVCB
- IUPAC Name:
- Partially hydrogenated β-3,7,11-trimethyldodeca-1,3,6,10-tetraene, reaction products with linear C8-C16 alpha olefin, hydrogenated.
- Test material form:
- other: Water white liquid
- Details on test material:
- Name: NovaSpec base oilBatch/Lot No.: TS13732CAS number: 1472010-43-7Chemical name: Alkenes, C-10-16a-, mixed with (6E)-7,11-dimethyl-3-methylene-116,10-dodecatriene, dimers, tetramers and trimers, hydrogenatedPurity: 100%Manufacture date: 06 June 2014Expiry date: 06 June 2016Description: Water white liquidStorage condition: Controlled room temperature (15-25 °C below 70 RH%)Safety Precautions: Routine safety precautions for unknown materials (lab coat, gloves, safety glasses and face mask) were applied to assure personnel health and safety.No correction for purity of the test item was applied.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:WI rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633, from SPF colony. Males and females originated from different units to avoid subsequent brother/sister matings.
Hygienic level: Standard laboratory conditions during the study
Justification of species/strain: The rat is regarded as a suitable species for toxicology and reproduction studies. Wistar rat was selected due to experience with this strain of rat in toxicity and reproduction toxicity studies and known fertility. Crl:WI rats were used for dose range finding study (study code:14/328-220PE).
Number of animals: 48 male, 48 female rats, 12 animals/sex/group, 4 groups (main animals); 10 male and 10 female rats, 5/sex/group (recovery group) and 12 males and 12 females rats in the positive control group for the micronucleus test).
Age of animals: Young adult rats, 10-11 weeks old at starting and 12-13 weeks at mating.
Body weight range: Males: 327 g – 478 g, Females: 207 g - 273 g;
Acclimation period: At least 5 days
Husbandry
Animal health: Only healthy animals were used for the test, as certified by the staff Veterinarian. Females were nulliparous and non-pregnant.
Room number: 508
Cage type: Type II and/or III polypropylene/polycarbonate
Bedding: Lignocel® and GRADE 5 type wooden chips were available to the animals
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.1 – 25.1 °C (target range 22±3°C)
Relative humidity: 31 – 64 % (target range 30-70%)
Ventilation: 15-20 air exchanges/hour
Housing/Enrichment: Rodents were group-housed, up to 5 animals of the same sex and dose group/cage, with the exception of the mating and gestation/delivery period, when they were paired or individually housed, respectively. Group housing allowed social interaction and the deep wood sawdust bedding allowed digging and other normal rodent activities (i.e. nesting)
.Food and water supply: Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and Maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from municipal supply, as for human consumption from 500 ml bottle ad libitum.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36, Hungary). The quality control results are retained in the archives at CiToxLAB Hungary Ltd.Food and water were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Animal identification: Each parental animal (P Generation) was identified by a number unique within the study written with indelible ink on the tail and cross-referenced to the Animal Master File at CiToxLAB Hungary Ltd. The animal number consisted of 4 digits, the first digit being the group number, the second, 0 for the males and 5 for the females, and the last 2, the animal number within the group, as indicated in the Experimental design section. The boxes (cages) were marked by identity cards, with information at least about study code, sex, dose group, cage number and individual animal numbers, date of mating and delivery. Boxes were arranged in such a way that possible effects due to cage placement were minimized.Randomization: All adult animals were sorted according to body weight by computer and divided in to weight ranges. There were an equal number of animals from each weight group randomly assigned to each dose group to ensure that the mean group weights were similar. The grouping was controlled by SPSS/PC software, according to the actual body weight verifying the homogeneity/variability between/within the groups and cages. Males and females were randomized separately.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Name: Poly(ethylene glycol) 400
Lot No.: BCBL5307V/BCBM8497V//BCBK 9981V
Manufacturer: Sigma-Aldrich Co.
Expiry Date: 31 January 2015/31 January 2016/January 2015
Storage: Room temperature
Name: 0.2% Polysorbate 80Lot No.: BCBL9041V/BCBN3690V
Manufacturer: Sigma-Aldrich Co.
Expiry Date: 30 November 2014/31 July 2016
Storage: Room temperature under inert gas
Preparation of the vehicle: For the preparation of 100 g (approximately 100 mL) vehicle, 0.2 g Polysorbate 80 was weighed by analytical balance into 99.8 g PEG 400, and was stirred by a magnetic stirrer. - Details on exposure:
- The test item was formulated in the vehicle as a visibly stable homogenous formulation at the appropriate concentrations according to the dose level and volume selected, in the Central Dispensary of CiToxLAB Hungary Ltd. Formulations were prepared for 7 days and kept in refrigerator pending dosage in the first 14 days of the study, and daily afterwards.The positive control material (cyclophosphamide) was dissolved in physiological saline (10 mg/mL) for the treatment. The solution was prepared just before the treatment. The test item solutions were given to assure the same dosing volumes in rat (2 mL/kg bw).No dose formulation analysis was performed from the positive control solutions.
- Duration of treatment / exposure:
- At least until the first scheduled euthanasia of dams.
- Frequency of treatment:
- Daily
- Post exposure period:
- At least 14 days after the first schedules euthanasia of dams
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 1000 mg/kg bw/dayBasis:nominal conc.
- No. of animals per sex per dose:
- 5 male and 5 female in the treatment group12 animals/sex/group served as the positive control group for the Mammalian Erythrocyte Micronucleus Test (MNT).
- Control animals:
- yes
- Positive control(s):
- 12 animals/sex/group served as the positive control group for the Mammalian Erythrocyte Micronucleus Test (MNT). They were mated and femalesallowed to deliver similarly to the Main animals, then treated once with 20 mg/kg bw Cyclophosphamide, administered by intraperitoneal injection(2 mL/kg bw) approximately 24 h prior to scheduled necropsy.
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes (PCEs) were scored per animal
- Details of tissue and slide preparation:
- At the end of the treatment period, bone marrow slides were prepared from all animals in the vehicle control and the positive control groups. The bone marrow was obtained from the right femurs of the rats immediately after euthanasia and flushed with foetal bovine serum (5 mL). The left femur of Main and Recovery group animals was used for routine histopathology, the left femur of positive control animals was discarded.After vortex mixing, the cell suspension was concentrated by centrifugation and the supernatant was discarded. Smears of the cell pellet were made on four standard microscope slides. Slides were then dried at room temperature until considered to be completely dry. Subsequently the slides were stained as follows:1. Fixed for a minimum of 5 minutes in methanol and allowed to air-dry.2. Stained with 10% Giemsa solution for 20 minutes.3. Rinsed in distilled water.4. Dried at room temperature (at least 12 hours).5. Coated with EZ-mountingPrior to sending to Microptic for microscopic analysis, one slide from each animal was given a code number for blind microscopic analysis. The code labels covered the original animal numbers to ensure that the slides were scored without bias.
- Evaluation criteria:
- Two thousand Polychromatic erythrocytes (PCEs) were scored per animal to assess the micronucleated cells. The frequency of micronucleated cells was expressed as percent of the micronucleated cells based on the first 2000 PCEs counted in the optic field. The proportion of immature among total (immature + mature) erythrocytes was determined for each animal by also counting a total of at least 1000 cells (immature erythrocytes, PCEs plus mature normochromatic erythrocytes, NCEs). During this process, the number of micronuclei was recorded in mature erythrocytes (NCEs) as well. Criteria for Identification of Micronucleated ErythrocytesA micronucleus is defined in following way:- A bluish mauve strongly coloured uniform round or oval particle in the cell.- The particle should be large enough for the colour to be recognisable, and it should be located inside the cells. Areas with micronucleus-like particles outside the cells should not be used for analysis.- During focusing, the particle should stay uniform in colour/light refraction and shape within a large interval and focus in the same plane as the erythrocyte.- The unit of damage is deemed to be the cell, and therefore cells with two or more micronuclei will be counted as single micronucleated cells. The Micronucelus Test is considered acceptable/valid in the conditions of this study, as it met the following criteria:- the frequencies of micronucleated polychromatic erythrocytes found in the negative and/or solvent controls fell within the range of historical laboratory control data.- the positive control item produced biologically relevant increases in the number of micronucleated polychromatic erythrocytes. - Each treated and control group included at least 5 analysable animals.
- Statistics:
- Statistical analysis was performed using Kruskal Wallis Non Parametric ANOVA test (level of significance 5%)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The groups with 1000 mg/kg bw (high dose) were compared with their vehicle control group using Kruskal Wallis test. These gave values of H = 0.014 in the males and H = 0.149 in the females. Both H values are non-significant, giving a negative response. The positive and negative control results were also compared, and gave a value of H = 17.633 (p<0.001) in the males, and H = 17.561 (p<0.001) in the females. The positive control treatment therefore caused a very substantial increase, demonstrating the sensitivity of the test system. The positive and negative control data are considered to give adequate data to confirm the validity of the study.
Any other information on results incl. tables
Table 1: Dose Group – Males – Negative Control
Animal no. |
Slide code |
Micronucleated PCE/2000 PCE |
PCE/1000 NCE+PCE |
1001 |
84 |
2 |
310 |
1002 |
101 |
3 |
291 |
1003 |
99 |
3 |
360 |
1004 |
43 |
3 |
356 |
1005 |
104 |
1 |
382 |
1006 |
26 |
3 |
305 |
1007 |
107 |
1 |
460 |
1008 |
5 |
2 |
372 |
1009 |
79 |
1 |
217 |
1010 |
16 |
1 |
432 |
1011 |
28 |
3 |
308 |
1012 |
22 |
1 |
380 |
Mean |
|
2.00 |
347.8 |
SD |
|
0.95 |
66.0 |
Table 2: Dose Group – Males – High Dose 1000 mg/kg bw 24h
Animal no. |
Slide code |
Micronucleated PCE/2000 PCE |
PCE/1000 NCE+PCE |
4001 |
106 |
2 |
361 |
4002 |
98 |
2 |
395 |
4003 |
116 |
5 |
370 |
4004 |
103 |
4 |
295 |
4005 |
25 |
2 |
336 |
4006 |
83 |
1 |
451 |
4007 |
56 |
2 |
425 |
4008 |
13 |
1 |
384 |
4009 |
54 |
4 |
391 |
4010 |
90 |
0 |
208 |
4011 |
36 |
1 |
369 |
4012 |
50 |
1 |
380 |
Mean |
|
2.08 |
363.8 |
SD |
|
1.51 |
62.9 |
Animal no. |
Slide code |
Micronucleated PCE/2000 PCE |
PCE/1000 NCE+PCE |
5001 |
24 |
7 |
213 |
5002 |
29 |
9 |
316 |
5003 |
33 |
11 |
481 |
5004 |
55 |
7 |
305 |
5005 |
111 |
7 |
200 |
5006 |
118 |
12 |
297 |
5007 |
113 |
10 |
215 |
5008 |
114 |
6 |
388 |
5009 |
15 |
10 |
221 |
5010 |
120 |
13 |
239 |
5011 |
44 |
32 |
395 |
5012 |
11 |
8 |
269 |
Mean |
|
11.00 |
294.9 |
SD |
|
6.97 |
88.0 |
Table 4: Dose Group – Females – Negative Control
Animal no. |
Slide code |
Micronucleated PCE/2000 PCE |
PCE/1000 NCE+PCE |
1501 |
20 |
3 |
601 |
1502 |
37 |
2 |
484 |
1503 |
70 |
1 |
536 |
1504 |
14 |
2 |
537 |
1505 |
32 |
1 |
544 |
1506 |
45 |
2 |
397 |
1507 |
10 |
0 |
511 |
1508 |
35 |
2 |
420 |
1509 |
1 |
3 |
409 |
1510 |
30 |
2 |
507 |
1511 |
19 |
5 |
509 |
1512 |
80 |
2 |
479 |
Mean |
|
2.08 |
494.5 |
SD |
|
1.24 |
60.8 |
Table 5: Dose Group – Females – High Dose 1000 mg/kg bw 48h
Animal no. |
Slide code |
Micronucleated PCE/2000 PCE |
PCE/1000 NCE+PCE |
4501 |
77 |
4 |
552 |
4502 |
62 |
1 |
589 |
4503 |
81 |
2 |
417 |
4504 |
4 |
1 |
554 |
4505 |
65 |
0 |
364 |
4506 |
109 |
2 |
489 |
4507 |
94 |
1 |
500 |
4508 |
74 |
0 |
556 |
4509 |
21 |
6 |
477 |
4510 |
88 |
3 |
419 |
4511 |
72 |
1 |
399 |
4512 |
57 |
5 |
486 |
Mean |
|
2.17 |
483.5 |
SD |
|
19.5 |
71.6 |
Table 6: Dose Group – Females - Cyclophosphamide
Animal no. |
Slide code |
Micronucleated PCE/2000 PCE |
PCE/1000 NCE+PCE |
5501 |
47 |
30 |
464 |
5502 |
75 |
52 |
569 |
5503 |
2 |
42 |
544 |
5504 |
87 |
35 |
424 |
5505 |
59 |
36 |
516 |
5506 |
49 |
101 |
592 |
5507 |
9 |
27 |
497 |
5508 |
38 |
162 |
522 |
5509 |
41 |
34 |
416 |
5510 |
96 |
11 |
271 |
5511 |
52 |
61 |
429 |
5512 |
34 |
37 |
399 |
Mean |
|
52.33 |
470.3 |
SD |
|
41.08 |
89.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negativeIn conclusion, no induction of micronuclei in bone marrow erythrocytes was observed following administration of NovaSpec Base Oil to rats at up to and including 1000 mg/kg bw. Thus there was no evidence of any genotoxic activity of the test item under the conditions of this part of the study.
- Executive summary:
The objective of this work phase is to assess the potential genotoxic effects of the test item by examining the induction of micronuclei in bone marrow erythrocytes of treated and control animals.
In conclusion, no induction of micronuclei in bone marrow erythrocytes was observed following administration of NovaSpec Base Oil to rats at up to and including 1000 mg/kg bw. Thus there was no evidence of any genotoxic activity of the test item under the conditions of this part of the study.
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