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EC number: 403-140-4 | CAS number: 103694-68-4 MAJANTOL; MAJANTOL R
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", by the Staff of the Division of Pharmacology, FDA.
- Version / remarks:
- 1959
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-(2,2-dimethyl-3-hydroxypropyl)toluene
- EC Number:
- 403-140-4
- EC Name:
- 3-(2,2-dimethyl-3-hydroxypropyl)toluene
- Cas Number:
- 103694-68-4
- Molecular formula:
- C12H18O
- IUPAC Name:
- 2,2-dimethyl-3-(3-methylphenyl)propan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 200-210 in average
- Fasting period before study: not specified
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 50 - 60 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Tylose (CMC) + Tween 20
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 or 30 %
- Amount of vehicle: 1 to 1.7 mL/100 g bw, respectively
MAXIMUM DOSE VOLUME APPLIED: 1.7 mL / 100 g bw - Doses:
- 2; 3; 4; 5 mL/kg bw
recalculated with the relative density of 0.97 this corresponds to
1.94; 2.91; 3.76; 4.84 g/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration and at day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: Slope of the mortality curve: 1.24
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 460 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 14-d LD50
- Mortality:
- Mortality / treated animals
Males
2 mL/kg bw (1940 mg/kg bw): 0/5
3 mL/kg bw (2910 mg/kg bw): 1/5
4 mL/kg bw (3760 mg/kg bw): 1/5
5 mL/kg bw (4840 mg/kg bw): 5/5
Females
2 mL/kg bw (1940 mg/kg bw): 0/5
3 mL/kg bw (2910 mg/kg bw): 0/5
4 mL/kg bw (3760 mg/kg bw): 3/5
5 mL/kg bw (4840 mg/kg bw): 5/5 - Clinical signs:
- other: In all dose groups the preparation caused apathy, sedation, tremor, incoordination, abdominal ache symptoms, bloody nose-secretion and readiness for reflexing. The above mentioned symptoms continued up to 4 days or caused mortalities. Animals of the hi
- Gross pathology:
- Animals who died within 24 hours did not show any remarkable symptoms. The late mortalities of group III showed hyperaemia of the digestive tract. The same findings were observed in the surviving animals after 14 days in dosage group III.
Any other information on results incl. tables
Table 1 Mortalities for both sexes, aggregated
Dose Group |
Dose level |
24 h |
7 days |
14 days |
I |
2 mL/kg bw (1940 mg/kg bw) |
0/10 |
0/10 |
0/10 |
II |
3 mL/kg bw (2910 mg/kg bw) |
0/10 |
1/10 |
1/10 |
III |
4 mL/kg bw (3760 mg/kg bw) |
1/10 |
4/10 |
4/10 |
IV |
5 mL/kg bw (4840 mg/kg bw) |
10/10 |
10/10 |
10/10 |
Table 2 Mean body weights males (g)
Dose Group |
Dose level |
Day 1 |
Day 14 |
I |
2 mL/kg bw (1940 mg/kg bw) |
205.2 ± 2.68 |
259.6 ± 6.88 |
II |
3 mL/kg bw (2910 mg/kg bw) |
204.8 ± 2.77 |
255.8 ± 5.38 |
III |
4 mL/kg bw (3760 mg/kg bw) |
205.2 ± 2.95 |
248.5 ± 5.74 |
IV |
5 mL/kg bw (4840 mg/kg bw) |
204.4 ± 2.70 |
- |
Table 2 Mean body weight females (g)
Dose Group |
Dose level |
Day 1 |
Day 14 |
I |
2 mL/kg bw (1940 mg/kg bw) |
205.0 ± 2.35 |
220.2 ± 4.97 |
II |
3 mL/kg bw (2910 mg/kg bw) |
204.2 ± 2.39 |
217.6 ± 5.41 |
III |
4 mL/kg bw (3760 mg/kg bw) |
205.4 ± 2.19 |
216.0 ± 4.00 |
IV |
5 mL/kg bw (4840 mg/kg bw) |
204.0 ± 1.87 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this acute oral toxicity study in the rat the LD50 was determined to be > 2000 mg/kg bw.
- Executive summary:
The test item was assessed for its acute oral toxicity in the rat at dose levels of 2, 3, 4, and 5 mL/kg bw, respectively, as a dilution in Tylose (CMC) and Tween20. The LD50 after 24 h was determined to be 4.25 mL/kg bw. The 14 -days LD50 was 3.57 mL/kg bw. Clinical signs of toxicity were observed and included apathy, sedation, tremor, incoordination, abdominal ache symptoms, bloody nose-secretion and readiness for reflexing. Mortalities occurred within 24 h in the highest dose group. Later mortalities were observed in dose group II and III. Body weight development was decreased in a dose-related manner. Pathological examination revealed hyperaemia of the digestive tract.
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