Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-585-2 | CAS number: 108-46-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Study was designed to comply with OECD 414 dated Jan. 22, 2001.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Resorcinol
- EC Number:
- 203-585-2
- EC Name:
- Resorcinol
- Cas Number:
- 108-46-3
- Molecular formula:
- C6H6O2
- IUPAC Name:
- resorcinol
- Details on test material:
- Resorcinol (AO11) >95% purity.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: purified water
- Duration of treatment / exposure:
- 6-19 days of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 24 per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- A total of 96 pregnant Sprague-Dawley female rats were allocated to four groups (24 per group). Three groups were administered with the test item,
Resorcinol (A011), by gavage once daily from day 6 to day 19 of gestation, inclusive, at the dose-level of 40, 80 or 250 mg/kg/day. One group of
females was only administered with the vehicle, purified water, at the same constant dose volume of 5 mL/kg; individual volumes were adjusted
according to the most recently recorded body weight.
Examinations
- Maternal examinations:
- The females were sacrificed on day 20 of gestation and subjected to a macroscopic examination.
- Fetal examinations:
- The numbers of corpora lutea, implantations and live fetuses were recorded. The fetuses were removed from the uterus, weighed, sexed and
externally examined. Half of the fetuses underwent soft tissue examination while the remaining fetuses received a skeletal examination. - Statistics:
- Statistical analysis: Mean values were compared by one-way analysis of variance and the Dunnett test (mean values being considered as normally
distributed and variances being considered as homogeneous). Percentage values were compared by the Fisher exact probability test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
Maternal body weight and food consumption: At 250 mg/kg/day, the net body weight change was significantly lower (p>0.05%, -19%) than the
control group value. There were no other treatment effects on maternal body weight, body weight gain or food consumption.
Macroscopic post-mortem examination: No findings recorded at maternal necropsy were considered to be treatment-related.
Pregnancy data: All the group mean numbers of implantations and live fetuses and the extent of pre- and post-implantation losses were comparable with the controls.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 80 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Mortalities and clinical observations: No premature deaths occurred during the study and no clinical observations were considered to be treatment-related.
Fetal
data:
In the treated groups, the mean numbers of corpora lutea, implantation
sites, live fetuses, resorptions (early and late) were similar to the
control group values.
The mean male and female fetus weights were significantly greater at 250
mg/kg/day, when compared to the controls. This observation was
considered to be the consequence of the low control group values
(outside the range of the last version of Historical Control Data 3.8 g
- 4.5 g, and within the range of the control group values during the
period where this study was conducted: 3.6 g - 3.9 g), rather than, an
effect of the treatment. The probability to mask an effect in fetal body
weights resulting from the low control group value was evaluated but was
considered to be with a
very low probability according to the homogeneity of individual fetal
body weights, the absence of a dose-related trend in fetal body weights
or the good general ossification of the skeletons. The percentage of
male fetuses was similar to controls for all groups. As a result, it was
concluded
that there were no effects of treatment on fetal body weight.
Fetal abnormalities:
No external, soft tissue or skeletal malformations or variations were
considered to be treatment-related.
There was a significantly increase in the incidence of fetuses with an
incompletely ossified interparietal at 40 and 80 mg/kg/day, when
compared to controls (p0.05 and p0.01, respectively). The incidence of
incompletely ossified parietals was also significantly greater at 80
mg/kg/day, when compared to controls (p0.05). In the absence of any
effects at 250 mg/kg/day these observations were not considered to be
treatment-related.
There was a significantly greater incidence of incompletely ossified 5th
sternebra at 250 mg/kg/day, when compared to controls (p0.01). The
thoraco-lumbar region is known to be particularly labile in the rat and,
in the absence of other variations or malformations, this observation
was not
considered to be treatment-related.
No fetal malformations or variants were considered to be related to
treatment.
Applicant's summary and conclusion
- Conclusions:
- The maternal No Observed Adverse Effect Level (NOAEL) of Resorcinol (A011) administered by oral route (gavage) to pregnant female rats was
considered to be 80 mg/kg/day based on statistically significant body weight changes and the developmental NOAEL was considered to be
250 mg/kg/day (highest dose tested).
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.