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EC number: 204-424-9 | CAS number: 120-78-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the teratogenic potential of rubber accelerator bibenzthiazyl disulphide in rats
- Author:
- Ema, M.; et al.
- Year:
- 1 989
- Bibliographic source:
- Journal of Applied Toxicology, vol. 9(6), 413-417
Materials and methods
- Principles of method if other than guideline:
- other: developmental toxicity study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Di(benzothiazol-2-yl) disulphide
- EC Number:
- 204-424-9
- EC Name:
- Di(benzothiazol-2-yl) disulphide
- Cas Number:
- 120-78-5
- Molecular formula:
- C14H8N2S4
- IUPAC Name:
- di(benzothiazol-2-yl) disulphide
- Details on test material:
- MBTS, purity: 97 to 98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: MBTS contained in the diet
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1: 1
- Length of cohabitation: overnight 15 h - Duration of treatment / exposure:
- From day 0 to day 20 of pregnancy
- Frequency of treatment:
- Daily
- Duration of test:
- Dams killed on day 20 of gestation (dams killed: 16 control, 14 low dose group, 18 mid dose group, 13 high dose group); five to six pregant rats in each group were allowed to deliver spontaneously; these dams were killed on day 21 after birth; the offspring of these dams were reared until until 7 weeks after birth
Doses / concentrationsopen allclose all
- Dose / conc.:
- 26 mg/kg bw/day
- Remarks:
- 0.04% group
- Dose / conc.:
- 127 mg/kg bw/day
- Remarks:
- 0.2% group
- Dose / conc.:
- 596 mg/kg bw/day
- Remarks:
- 1% group
- No. of animals per sex per dose:
- 15 to 19 per dose (dams kiled on day 20 of pregnancy); in an addition approach dams (5 to 6 per group) delivered offspring and were killed on day 21 after birth
- Control animals:
- yes, plain diet
Examinations
- Maternal examinations:
- Death, clinical sign od toxicity, body weight gain, food consumption, pregnancy rate.
- Ovaries and uterine content:
- Pre- and post implantation losses, numbers of corpora lutea per litter, implantations per litter, live fetuses per litter, sex ratio of live fetuses, fetal body weight of both sexes and placental weight.
- Fetal examinations:
- External, skeletal and internal malformations.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 596 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 127 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 596 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 596 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Maternal findings:
Mortality: no death occured during the study
Clinical signs: no clinical signs were noted in any of the treated animals or control animals
Body weight gain: maternal body weight gain during day 0 to 14 of pregnancy was significant reduced in the high dose group (1% MBTS in the diet) compared to control
Food consumption: no significant differences in food consumption was observed in treated females compared to control, however the food consumption was lower in the high dose group compared to control
Pregnancy rate: no significant differences were noted in the pregnancy rate in treated females compared to control
Table: maternal findings
Dietary level of MBTS (%) | 0 | 0.04 | 0.2 | 1 | |
No of rat (pregnant/copulated) | 16/17 | 14/16 | 18/19 | 13/15 | |
Body weight gain during pregnancy (g)ab | |||||
Day 0 to day 7 of pregnancy | 11 ± 8 | 12 ± 5 | 9 ± 8 | 7 ± 7 | |
Day 0 to 14 of pregnancy | 38 ± 7 | 41 ± 7 | 36 ± 9 | 31 ± 10* | |
Day 0 to day 20 of pregnancy | 99 ± 14 | 107 ± 12 | 100 ± 15 | 94 ± 18 | |
Food consumption during pregnancy (g)ab | |||||
Day 0 to day 7 of pregnancy | 89 ± 10 | 88 ± 14 | 88 ± 11 | 80 ± 14 | |
Day 0 to day 14 of pregnancy | 206 ± 18 | 203 ± 23 | 200 ± 18 | 194 ± 24 | |
Day 0 to day 20 of pregnancy | 329 ± 27 | 323 ± 37 | 324 ± 27 | 314 ± 30 | |
Daily intake of MBTS (mg kg bw/day)ab | - | 26 ± 2 | 127 ± 14 | 596 ± 60 |
a: Expressed as mean ± SD
b: non-pregnant rats were excluded
* significant different from control
Reproduction findings:
There were no significant differences in the incidences of pre-and postimplantation losses, the number of corpora lutea per litter, implantations per litter and live fetuses per litter, the sex ratio of live fetuses, the fetuses body weight of both sexes and the placental weight.
Table: Reproductive findings in rats given dietary MBTS
Dietary level of MBTS (%) | 0 | 0.04 | 0.2 | 1 | |
No. of litters | 16 | 14 | 18 | 13 | |
No. of corpora lutea per littera | 12.3 ± 1.6 | 11.7 ± 1.7 | 12.6 ± 1.8 | 13.1 ± 1.3 | |
No. of implantations per littera | 11.6 ± 1.2 | 11.1 ± 1.7 | 11.6 ± 1.5 | 11.5 ± 2.0 | |
Preimplantation loss per litter (%)b | 4.5 | 5.4 | 7.6 | 12.3 | |
Postimplantation loss per litter (%)c | 9.2 | 2.3 | 9.5 | 7.8 | |
No. of live fetuses per littera | 10.6 ± 1.9 | 10.8 ± 1.6 | 10.3 ± 1.2 | 10.6 ± 2.5 | |
Sex ratio of live fetuses (male/female) | 75/94 | 69/82 | 94/92 | 72/66 | |
body weight of live fetuses (g)a | |||||
Male | 4.29 ± 0.33 | 4.32 ± 0.23 | 4.27 ± 0.30 | 4.16 ± 0.17 | |
Female | 3.99 ± 0.35 | 4.18 ± 0.24 | 4.06 ± 0.22 | 3.92 ± 0.19 | |
Placental weight (g)a | 0.47 ± 0.05 | 0.49 ± 0.05 | 0.5 ± 0.07 | 0.5 ± 0.08 |
Offspring Morphological findings in fetuses of rats given dietary MBTS Table: morphological findings in fetuses Dietary level of MBTS (%) 0 0.04 0.2 1
b: b: (No. of corpora lutea minus no.of implantations/ no. of corpora lutea) X 100. c: (No. of implantations minus no. of live fetuses/ no. of implantations) X 100. Offspring Morphological findings in fetuses of rats given dietary MBTS Table: morphological findings in fetuses Dietary level of MBTS (%) 0 0.04 0.2 1
a: Expressed as mean ± SD b:
b: (No. of corpora lutea minus no.of implantations/ no. of corpora lutea) X 100.
c: (No. of implantations minus no. of live fetuses/ no. of implantations) X 100.
Offspring
Morphological findings in fetuses of rats given dietary MBTS:
No treatment-related effects for external, skeletal and internal malformation were noted. The incidences of the fetuses and litters that had skeletal variations or delayed ossifications were not significantly different between MBTS-treated animals and control group. There was no significant difference between the MBTS-treated and control group in the degree of ossification, indicated by the numbers of the caudal vertebrae.
Table: morphological findings in fetuses
Dietary level of MBTS (%) | 0 | 0.04 | 0.2 | 1 | |
External examinationNo. of fetuses (litters) examined | 169(16) | 151(14) | 186(18) | 138(13) | |
No of fetuses (litters) with anomalies | 3(2) | 0 | 1(1) | 0 | |
Cleft palate | 2(1) | 0 | 1(1) | 0 | |
General oedema | 1(1) | 0 | 0 | 0 | |
Skeletal examination | |||||
No. of fetuses (litters) examined | 112(16) | 101(14) | 124(18) | 92(13) | |
No. of fetuses (litters) with anomalies | 1(1) | 0 | 0 | 0 | |
Fusion of the cervical vertebral arches | 1(1) | 0 | 0 | 0 | |
No. of fetuses (litters) with variations | |||||
Cervical ribs | 9(4) | 15(5) | 8(6) | 13(6) | |
Shortening 13th ribs | 4(3) | 6(2) | 1(1) | 3(3) | |
Asymmetry of the sternebrae | 2(2) | 0 | 1(1) | 0 | |
Splitting sternebrae | 1(1) | 0 | 1(1) | 0 | |
Lumbar ribs | 2(2) | 0 | 0 | 0 | |
Extralumbar vertebrae | 2(2) | 0 | 0 | 1(1) | |
Splitting vertebral bodies | 0 | 0 | 1(1) | 0 | |
No. of fetuses (litters) with delayed ossification | |||||
Sternebrae | 11(6) | 7(4) | 5(4) | 6(3) | |
Supraoccipital bone | 0 | 0 | 1(1) | 0 | |
Degree of ossification | |||||
No. of caudal vertebraea | 4.5 ± 0.6 | 4.5 ± 0.6 | 4.3 ± 0.4 | 4.5 ± 0.4 | |
Internal examination | |||||
No. of fetuses (litters) examined | 57(16) | 50(14) | 62(18) | 46(13) | |
No. of fetuses (litters) with anomalies | 2(1) | 0 | 1(1) | 0 | |
Hydrocephaly | 2(1) | 0 | 1(1) | 0 |
Postnatal findings in offspring of rats given dietary MBTS Table: postnatal findings in offspring ietary level of MBTS (%) 0 0.04 0.2 1
a: expressed as mean ± SD Postnatal findings in offspring of rats given dietary MBTS Table: postnatal findings in offspring ietary level of MBTS (%) 0 0.04 0.2 1
a: expressed as mean ± SD
Note: extra group (number of dams unclear, dams killed on day 21 after birth)
Postnatal findings in offspring of rats given dietary MBTS (extra group:offspring killed 7 weeks after birth)
No significant differences between the MBTS-treated animals and control groups were found in the gestation lengh of maternal rats, the numbers of implantation remnants per litter and live newborns per litter and the live birth index. The survival rate of the offspring before and after weaning was very high and almost constant in all groups. Autopsy of the dead offspring of the MBTS-treated groups revealed no consistent tendency, and the cause of death remained unclear. The body weights of offspring for both sexes was not signifcant different between MBTS treated animals and control up to week 7 (postnatal)
Table: postnatal findings in offspring
Dietary level of MBTS (%) | 0 | 0.04 | 0.2 | 1 | |
No. of litters | 6 | 5 | 6 | 6 | |
Length of gestation (day)a | 21.0 ± 0 | 21.4 ± 0.5 | 21.2 ± 0.4 | 21.7 ± 0.5 | |
No. of implantation remnants per littera | 10.2 ± 4.3 | 11.0 ± 1.9 | 10.8 ± 0.8 | 12.2 ± 2.1 | |
No. of live newborns per littera | 9.5 ± 4.2 | 8.6 ± 3.6 | 9.7 ± 1.2 | 9.5 ± 1.4 | |
Live-birth index (%)b | 94.0 | 76.9 | 89 -1 | 79 .7 | |
Survival rate of offspring (%)c | |||||
Day 7 | 95.8 | 100 | 95.8 | 100 | |
Day21 | 91.7 | 100 | 89.6 | 100 | |
Week 7 | 91.7 | 100 | 87.5 | 100 | |
Body weight of offspring (g)a | |||||
Day 21 | |||||
Male | 56.2 ± 3.7 | 54.3 ± 3.3 | 54.7 ± 5.2 | 54.0 ± 5.1 | |
Female | 53.8 ± 3.5 | 52.8 ± 2.8 | 53.9 ± 5.1 | 51.1 ± 5.7 | |
Week 7 | |||||
Male | 231 ± 26 | 218 ± 31 | 230 ± 27 | 224 ± 18 | |
Female | 177 ± 16 | 171 ± 14 | 178 ± 20 | 171 ± 13 |
a: Expressed as mean ± SD
b: (No. of live newborns at birth/no. of implantation remnants) X 100.
c (No. of live offspring/ no. of newborns after adjustment of litter size at birth) X 100.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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