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EC number: 915-589-8 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity in rats: LD 50 > 5000 mg/kg bw
Acute dermal toxicity in rabbits: LD 50 > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 21, 1986 - May 16, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (US EPA)
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA (US EPA)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: CDR (Sprague-Dawley derived)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species: Albino rats, CDR (Srague-Dawley derived)
- Source: Charles River Breeding Laboratories, Inc; Wilmington , Massachusetts, USA
- Age at study initiation: Young adults /approx. 9-12 weeks
- Weight at study initiation (prefasted): - Males: 250 - 338 g
- Females: 212 - 269 g
- Fasting period before study: approx. 18 h
- Housing: Group housed (6 per cage) during acclimation, individually during study in suspended stainless steel cages with wire mesh bottoms
- Diet: Purina Laboratory Chow, ad libitum
- Water: ad libitum
- Acclimation period: 8, 10 or 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 24.5°C (= 67 - 76°F)
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Test material was administered by oral intubation, using a ball-tipped intubation needle fitted onto a syringe
- Doses:
- 4000 mg/kg, 5000 mg/kg, 6250 mg/kg
- No. of animals per sex per dose:
- 5 (except 5000 mg/kg dose: 10 male, 5 female)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1 h, 2 h, and 4 h after application; thereafter daily for 14 days
- Frequency of weighing: Pre-fast, post-fast, day 7 and day 14
- Necropsy of survivors performed: yes
- Gross postmortem examinations were performed on all animals which died or were found dead during the study - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- see table below
- Clinical signs:
- other: No abnormalities were observed during 4 h after application. 24 h after application and/or day 2 most animals exhibited hypoactivity, soft stool, fecal and/or urinary staining. All surviving animals were free of significant abnormalities at termination of
- Gross pathology:
- Postmortem examinations of animals found dead during the study revealed primarily changes in lungs and gastrointestinal tract.
Several animals exhibited changes in the stomach and intestine which were suggestive of a corrosive effect.
Other changes appeared to represent autolytic changes or antemortem stress. - Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- The test substance, alkylation and transalkylation products of biphenyl with propene, showed low toxicity only.
Reference
Dose levels and mortality (excerpt from original report):
Dose level (mg/kg) |
Mortality |
|||
Male |
Female |
Total |
Time of death (day) |
|
4000 |
1/5 |
1/5 |
2/10 |
2 - 3 |
5000 (A) |
(4/5) a |
1/5 |
a |
2 – 7 |
5000 (B) |
2/5 |
- |
2/5 |
2 – 4 |
6250 |
2/5 |
1/5 |
3/10 |
2 - 3 |
a: Because the weight of males dosed initially at 5000 mg/kg [designated 5000 (A)] exceeded the weight range of males dosed at the other two levels, an additional group of males in the same weight range as males in the other two dose levels was dosed [(designated 5000 (B)].
Only data from the 5000 (B) group were considered for estimation of LD50.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study KLimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 27, 1986 - Feb 26, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (US EPA)
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA (US EPA)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species: New Zealand White, albino rabbits
- Source: Hazleton-Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: young adult (at least 8 weeks)
- Weight at study initiation: - Males: 2.4 - 2.8 kg
- Females: 2.6 - 2.8 kg
- Housing: individually in suspended stainless steel cages with wire mesh bottoms
- Diet: Lab Rabbit Chow HF, ad libitum:
- Water: ad libitum
- Acclimation period: 16 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 16°C - 21°C (60 - 70°F)
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped intact skin of the dorsal area of the trunk
- Application: directly onto the skin and spread evenly over the entire area
- Type of wrap if used: Gauze, impervious plastic sleeve secured by Elizabethan collars
REMOVAL OF TEST SUBSTANCE
Following 24 h of exposure, wrappings were removed and test sites wiped free of excess test material
TEST MATERIAL
- Amount applied: 5.2 ml/kg
- Concentration: undiluted - Duration of exposure:
- 24 h
- Doses:
- single dose (5.2 ml/kg = ca. 5000 mg/kg)
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, and 4 h after application and daily thereafter for 14 days
- Frequency of weighing: Pre-test (at the time of clipping), pre-dose (for calculation of doses), day 7 and day 14
- Necropsy of survivors performed: yes
- Necropsy observations: Lung, ovaries, uterus - Statistics:
- not appicable (limit test)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived throughout the study.
- Clinical signs:
- other: Few (female) animals exhibited severe dermal effects at the dose site (necrosis followed by eschar formation, fissuring and/or exfoliation of the eschar tissue) between day 3 and day 9 (see table below). All animals were free of abnormal signs from day 1
- Gross pathology:
- Gross postmortem observations were similar to those seen in control animals or represent normal physiological variation.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- The test substance, alkylation and transalkylation products of biphenyl with propene showed no systemic toxicity after dermal exposure to rabbits.
Reference
Summary of pharmacologic and toxicologic signs (excerpt from orignal report)
Day |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
Hr |
1 |
2 |
3 |
4 |
24 |
||||||||||||||
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
||
Observation |
|||||||||||||||||||
Food consumption decrease |
- |
- |
- |
- |
- |
- |
- |
2/2 |
2/3 |
1/1 |
1/2 |
2/1 |
- |
- |
- |
- |
- |
1/- |
- |
Necrosis |
- |
- |
- |
- |
- |
- |
- |
-/2 |
-/2 |
-/2 |
-/2 |
-/2 |
-/1 |
- |
- |
- |
- |
- |
- |
Eschar |
- |
- |
- |
- |
- |
- |
- |
- |
- |
-/2 |
-/2 |
-/2 |
-/1 |
- |
- |
- |
- |
- |
- |
Exfoliation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
-/1 |
-/2 |
-/2 |
-/1 |
- |
- |
- |
- |
- |
Fissuring |
- |
- |
- |
- |
- |
- |
- |
-/1 |
-/2 |
-/2 |
-/2 |
- |
- |
- |
- |
- |
- |
- |
- |
M: male, F: female
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study KLimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Alkylation and transalkylation products of biphenyl with propene (DIPB/TIPB) produces no acute toxicity but at very high doses.
Mortality was only observed following oral exposure of the neat substance without reaching the LC50 discriminating dose (5000 mg/kg bw).
Justification for selection of
acute toxicity – oral endpoint
The high doses selected were lethal in a few cases but did not reach
the LD50, and caused intoxication as evidenced by clinical signs and
macroscopic observations.
Justification for selection of acute toxicity – dermal endpoint
The limit dose selected was not lethal. However, there was evidence
of skin irritation.
Justification for classification or non-classification
According to criteria set in either directive 67/548/EEC or Regulation (EC) No 1272/2008, Alkylation and transalkylation products of biphenyl with propene is not acutely toxic. Classification is not required.
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.