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EC number: 500-130-2 | CAS number: 55818-57-0
- 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
- Study period:
- 04 June 2014 -- 04 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid
- EC Number:
- 500-130-2
- EC Name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid
- Cas Number:
- 55818-57-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of (4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane) and 2-propenoic acid
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: within ± 20% of the mean body weight of all the study animals of the same sex (245 g for females and 412 g for males).
- Fasting period before study: No
- Housing: polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: 17 June 2014 to 04 July 2014
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage
REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad with acetone and then water for injection
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume: no
- For solids, paste formed: yes - Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- ten rats (five males + five nulliparous and non pregnant females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment, on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Statistics:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed in any animals.
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity were observed in any animals. No cutaneous reactions were observed in any males. A very slight to well defined erythema at the application site was noted in all females from Day 2, 3 or 4 until Day 14 at t
- Gross pathology:
- There were no test item-related gross findings.
The irregular color noted in the lungs from 3/5 males treated at 2000 mg/kg/day was considered to be most probably unrelated with test item administration since this was not seen in females, and since this finding is occasionally seen in untreated rats of these strain, age, and supplier. - Other findings:
- no
Any other information on results incl. tables
Table 1.
Sex |
Female |
Male |
||
Group |
Historical control data |
1 |
Historical control data |
2 |
Dose-level (mg/kg) |
0 |
2000 |
0 |
2000 |
Body weight (mean (± SD)) |
|
|
|
|
. Day 1 |
217 (± 10.3) |
215 (± 7.6) |
333 (± 10.3) |
412 (± 15.8) |
. Day 8 |
242 (± 10.6) |
229 (± 7.1) |
372 (± 9.5) |
450 (± 16.5) |
. Day 15 |
269 (± 13.0) |
245 (± 6.2) |
422 (± 12.6) |
485 (± 25.5) |
Body weight change (mean (± SD)) |
|
|
|
|
. Days 1-8 |
+25 (± 10.0) |
14 (± 2.2) |
+39 (± 11.5) |
37 (± 4.8) |
. Days 8-15 |
+27 (± 11.1) |
17 (± 8.9) |
+50 (± 12.0) |
35 (± 10.5) |
. Days 1-15 |
+52 (± 12.9) |
31 (± 8.5) |
+89 (± 12.8) |
72 (± 12.3) |
SD: standard deviations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the dermal LD50 of the test item was higher than 2000 mg/kg in rats.
- Executive summary:
The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats.
This study was based on the international guidelines (OECD No. 402 and Council Regulation No. 440/2008 of 30 May 2008, Part B.3) and was performed in compliance with the principles of Good Laboratory Practice.
Methods
The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. From Day 2, any local reactions at the treatment site were also noted. Body weight was recorded on Day 1 and then on Days 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study report as no microscopic examination was performed.
Results
No unscheduled deaths occurred during the study.
No clinical signs indicative of systemic toxicity were observed in any animals.
No cutaneous reactions were observed in any males.
A very slight to well-defined erythema at the application site was noted in all females from Day 2, 3 or 4 until Day 14 at the latest along with dryness of the skin in 4/5 females from Day 4 until Day 14 at the latest. Scabs were noted in 3/5 females from Day 3 to Day 11 and wound in 1/5 females from Day 4 to Day 7.
When compared to historical control data, lower body weight gain was noted in 3/5 females between Day 1 and Day 8; and in 1/5 other females between Day 8 and Day 15. Over the period from Day 1 to Day 15, 4/5 females had a lower body weight gain when compared to historical control data.
A lower body weight gain was also noted in 3/5 males between Day 8 and Day 15 and over the study period when compared to historical control data. However, the body weight of test-item treated males on Day 1 was significantly higher than the body weight of males in historical control data. This could explain that the body weight gain of test item-treated males was lowered in some animals.
The body weights of the other animals were unaffected by the test item treatment.
There were no test item-related gross findings.
Conclusion
Under the experimental conditions of this study, the dermal LD50 of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by dermal route according to the criteria of CLP Regulation.
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