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EC number: 239-816-9 | CAS number: 15721-78-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats and an observation period of 14 days.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
- EC Number:
- 239-816-9
- EC Name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
- Cas Number:
- 15721-78-5
- Molecular formula:
- C28-H43-N
- IUPAC Name:
- 4-(2,4,4-trimethylpentan-2-yl)-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]aniline
- Details on test material:
- Identification : Bis(4-(1,1,3,3-tetramethylbutyl)phenyl amine
Appearance : Off White Solid
Batch number : Lot. 03/31
CAS No. : 15721-78-5
AI Content : 98.72%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species :Rat (Rattus norvegicus)
Strain :Wistar
Sex :Male and Female
Number of Animals :10 (Five per sex)
Supplier/Source :In-House
Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
Body weight of animals:male:minimum: 234 g and Maximum: 282 g (Prior to Treatment)Female: Minimum: 237 g and Maximum: 253 g
Acclimatisation :All animals were acclimatized to the test conditions for 8 days prior to test item application
Randomization :Animals were selected manually. No computer generated randomization program was used.
Diet :All animals were provided conventional laboratory rodent diet ad libitum. Batch No 400010 and 400011.
Bedding :All cages were provided with corn cobs
Water :Aqua guard filtered tap water was provided ad libitum via drinking bottles.
Husbandry :The animals were housed individually in polycarbonate cages.
Room Sanitation :The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
Cages and water bottle:All the cages and water bottles were changed at least twice every week
Temperature :Minimum: 19.60 °C Maximum: 21.40 °C
Relative humidity :Minimum: 47.40% Maximum: 58.60%
Light-dark-rhythm:12 hour light and 12 hour dark
Air Changes :More than 12 changes per hour
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (greater than 10% body surface area) of rats was clipped by using clipper
- Duration of exposure:
- 24-hour
The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 13:01 to 13:09 - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male & 5 female
- Control animals:
- yes
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
- Clinical signs:
- other: At 2000 mg/kg, all the animals were observed normal throughout the experimental period
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
- Other findings:
- not specified
Any other information on results incl. tables
TABLES
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight
Animal No. |
Sex |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
Male |
282 |
290 |
301 |
2.84 |
6.74 |
2 |
268 |
273 |
283 |
1.87 |
5.60 |
|
3 |
257 |
260 |
271 |
1.17 |
5.45 |
|
4 |
263 |
266 |
287 |
1.14 |
9.13 |
|
5 |
234 |
244 |
254 |
4.27 |
8.55 |
|
6 |
Female |
253 |
255 |
259 |
0.79 |
2.37 |
7 |
247 |
249 |
253 |
0.81 |
2.43 |
|
8 |
237 |
239 |
243 |
0.84 |
2.53 |
|
9 |
243 |
246 |
251 |
1.23 |
3.29 |
|
10 |
239 |
242 |
247 |
1.26 |
3.35 |
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
|||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Animal No. |
Sex |
Day |
||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key: 1 = Normal
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Days of Observation (0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
Male |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
Female |
No mortality and morbidity |
No mortality and morbidity |
7 |
No mortality and morbidity |
No mortality and morbidity |
|
8 |
No mortality and morbidity |
No mortality and morbidity |
|
9 |
No mortality and morbidity |
No mortality and morbidity |
|
10 |
No mortality and morbidity |
No mortality and morbidity |
Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)
Dose:2000 mg/kg body weight
Sex |
Body Weight (gram) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
Male |
Mean |
260.80 |
266.60 |
279.20 |
2.26 |
7.09 |
SD |
17.60 |
16.91 |
17.70 |
1.32 |
1.68 |
|
n |
5 |
5 |
5 |
5 |
5 |
|
Female |
Mean |
243.80 |
246.20 |
250.60 |
0.99 |
2.79 |
SD |
6.42 |
6.22 |
6.07 |
0.24 |
0.48 |
|
n |
5 |
5 |
5 |
5 |
5 |
Keys:SD= Standard deviation, n = Number of animals
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight.
- Executive summary:
Acute Dermal Toxicity Study of test chemical was conducted in Wistar Rats.This study was performed as per OECD No.402.Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.
On test day 0, an amount of testitem moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.After the 24-hour application period, the dressings were removed and theskin was gently wiped with distilled water.The skin reactions were assessed.
The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period. At 2000 mg/kg, all the animals were normal throughout the experimental period.Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0
The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
Thus considering the CLP Criteria for classification of the substance, it is concluded that test chemical could no texhibit acute toxicity to rat by the dermal route.
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