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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Version / remarks:
- ; Other: EPA OPPTS 870.3800
- Deviations:
- yes
- Remarks:
- : Minor study deviations were noted however these deviations did not adversly effect the quality or integrity of the data or the study outcome.
- GLP compliance:
- yes
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on mating procedure:
- Male: F0: 70 days, F1: 70 days beginning at weaning
Female: F0: 70 days, F1: 70 days beginning at weaning - Duration of treatment / exposure:
- 70 days prior to mating and throughout mating, gestation and lactation
- Frequency of treatment:
- Continuous
- Details on study schedule:
- Duration of test: 18 months
No. of generation studies: 2
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 120, 360, 1000 and 3000 mg/l
Basis:
- No. of animals per sex per dose:
- 30/sex/group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Four groups of male and female Crl:CD SD rats (30/sex/group) were administered resorcinol in drinking water for at least 70 consecutive days prior
to mating. Exposure levels were 0, 120, 360, 1000 and 3000 mg/L for the F0 and F1 generations. The concurrent control group (30/sex/group)
received reversed osmosis purified municipal water. The test article was administered to the offspring selected to become the F1 parental generation following weaning (post natal day 21). The F0 and F1 males continued to receive the test article throughout the mating and through the day of
euthanasia. The F0 and F1 females continued to receive the test article throughout mating, gestation, lactation and through the day of euthanasia.
Examinations
- Statistics:
- All statistical tests were performed using appropriate computing devices or programs.
- Reproductive indices:
- Study was conducted to evaluate the potential adverse effects of resorcinol on the reproductive capabilities, including gonadal function, estrous
cyclicity, mating behaviour, conception, gestation, parturition, lactation and weaning of the F0 and F1 generations. - Offspring viability indices:
- Study was conducted to evaluate the potential adverse effects of resorcinol on the F1 and F2 neonatal survival, growth and development.
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed in highest dose tested
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- water consumption and compound intake
Results: P1 (second parental generation)
Effect levels (P1)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed in highest dose tested
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- water consumption and compound intake
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 3 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed in highest dose tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
RM-Freetext:
Although not indicated by the study author, we have concluded that the overall systemic NOEL for males and females is 1000 mg/L based on reduced body weight at 3000 mg/L.
RS-Freetext:
No effects on any of the reproductive parameters
When
expressed on a body weight basis (average F0 and F1 animals), the water
concentrations corresponded to: approximately 0, 11, 31, 86 and 223
mg/kg/day for males over the entire generation; 16, 48, 126 and 304
mg/kg/day for females during premating and gestation; and 28, 85, 225,
and 660 mg/kg/day for females during lactation, respectively.
In
offspring (the F1 generation only), the water concentrations
corresponded to approximately 0,11,33,93 and 245 mg/kg/day in males
while in females 0, 16, 41, 126 and 295 mg/kg/day.
There were no F0 or F1 parental test article-related deaths or clinical
findings during the weekly detailed physical examinations. Reproductive
performance (estrous cycles, mating and fertility indices, number of
days between pairing and coitus, and gestation length) and parturition
in the F0 and F1 animals were unaffected by the test article.
Spermatogenic
endpoints (mean testicular and epididymal sperm numbers and sperm
production rate, motility, progressive motility and morphology) in the
F0 and F1 males were unaffected by the test article. No test
article-related effects were observed on F1 and F2 pup survival or the
general physical condition of the pups during the pre-weaning period. No
test article-related macroscopic findings, organ weight or adverse
microscopic target-organ effects were observed in the F0 or F1 parental
animals. In addition, no test article-related macroscopic findings or
effects on organ weights were noted in the F1 or F2 pups at the
scheduled necropsies; no test article-related macroscopic findings were
noted for found dead F1 or F2 pups. No effects of the test article were
observed on the mean days of acquisition of balanopreputial separation
and vaginal patency in the F1 pups.
Decreased (not statistically significant) mean cumulative body weight
gains were noted in the 3000 mg/L group F0 males during study days 0-70
(pre-mating period) and study days 0-126 (entire generation). While
weekly mean body weight gain differences from the control group were
only statistically significant during study days 91-98, the reduced mean
cumulative body weight gains in the 3000 mg/L group males corresponded
to decreased water consumption and were considered test article-related.
Mean body weights were unaffected in the 3000 mg/L group males;
differences from the control group were slight and not statistically
significant.
A decreased (not statistically significant) mean cumulative body weight
gain was noted in the 3000 mg/L group F0 females during study days 0-70
(pre-mating period).
There were no clear trends in the weekly mean body weight gains for
these females; however, mean body weights were reduced in these females
from study days 56 through 70 (prior to mating; 5.1% to 6.3%) and after
the end of lactation on study day 126 (6.3%). Only the reduction on
study day 126 was statistically significant (p0.01). The decreased mean
body weights and cumulative body weight gain in this group corresponded
to decreased water consumption and were considered test article-related.
There were no effects on mean body weights or body weight gains in the
120, 360 and 1000 mg/L groups. Differences from the control group were
slight, did not occur in an exposure-related manner and/or were not
statistically significant.
Decreased mean water consumption was noted for the 3000 mg/L group F0
and F1 parental animals during the pre-mating period (females) or the
entire generation (males) and for the F1 pups gang-housed by litter from
PND 21-28. Water consumption was also often decreased in the 1000 mg/L
group males and females, although the decreases were less severe and the
onset was later than in the 3000 mg/L group. Mean water consumption in
the 1000 mg/L group was consistently reduced compared to the control
group beginning on study days 21-24; however, slight decreases were also
noted inconsistently earlier in the pre-mating period. The decreased
water consumption in the 1000 mg/L group continued through the first
week of gestation while the decreased water consumption in the 3000 mg/L
group females continued throughout gestation and lactation. The test
article-related decreases in water consumption were not considered an
adverse change due to the lack of associated effects on food intake and
food utilization.
Hormone Analysis:
No statistically significant test article-related changes in the mean
concentrations of T3, T4 or TSH were noted in the F0 or F1 parental
animals or in the F1 or F2 pups selected for analysis (PND 4 or PND 21).
The higher TSH values noted in the F0 males at the scheduled necropsy
were not considered test article-related in the absence of effects on T3
or T4, organ weights or adverse macroscopic or microscopic findings.
Test article-related decreased colloid within the thyroid glands of the
3000 mg/L F0 males was not considered adverse due to the lack of
associated functional effects.
Applicant's summary and conclusion
- Conclusions:
- Decreased mean water consumption was noted for the 1000 mg/L (F0 generation only) and 3000 mg/L group F0 and F1 parental animals due to the
poor palatability of water containing the two highest concentrations of Resorcinol. The test article-related decreases in water consumption were not
considered adverse even in the 3000 mg/L group because of the lack of associated effects on food intake and food utilization, which indicated that
homeostasis was uncompromised.
Test article-related reductions in mean body weights and/or body weight gains were observed in both parental generations in the 3000 mg/L group. However, there was no evidence of cumulative effects on mean body weights or body weight gains when evaluated across two generations, nor was
there evidence of gender-related effects or of enhanced sensitivity of females to the test article during gestation and lactation.
Decreased mean cumulative body weight gains were noted in the 3000 mg/L F0 group during the premating period (females) and the entire
generation (males). While no definite trends were apparent in weekly mean body weight gains for these animals, mean body weights were reduced in
the F0 females prior to mating (up to 6.3%), during gestation (up to 5.5%) and throughout lactation (up to 8.4%). Mean body weights were unaffected inthe 3000 mg/L group F0 males. A decreased mean cumulative body weight gain was also noted for the 3000 mg/L group F1 males for the entire
generation, corresponding to decreased (up to 7.1%) mean body weights throughout the generation.
There were no clear effects on mean body weight gains in the 3000 mg/L group F1 females; however, mean body weights were decreased in these
females during lactation (up to 6.1%) and after the lactation period ended (up to 7.0%). These reductions were most likely due to poor palatability of
the drinking water containing 3000 mg Resorcinol/L as evidenced by the correspondingly reduced water consumption recorded for these animals.
Decreased water consumption was noted in F0 and F1 males and females at 3000 mg/L and, to a lesser extent, in F0 males and females at an
exposure level of 1000 mg/L during the pre-mating period. However, there were no effects on mean body weights or body weight gains in the 120,
360 and 1000 mg/L group F0 and F1 males and females. During gestation and lactation, water consumption was decreased in both the F0 and F1
females in the 3000 mg/L group. Water consumption remained decreased for these females after the end of the lactation period. In addition, water
consumption was reduced at an exposure level of 3000 mg/L in the F1 generation during the week following weaning (PND 21-28) when the animals were housed by litter. The test article-related decreases in water consumption were not considered adverse due to the lack of associated effects on
food intake and food utilization, which indicated that homeostasis was uncompromised.
The NOAEL is considered to be 3000 mg Resorcinol/L for parental systemic and offspring toxicity (ca. Average F0 and F1 generation 223 mg/kg/day (males), 304 mg/kg/day (females(premating and gestation)), 660 mg/kg/day (females(lactation)) (F1 generation (males) 245 mg/kg/day and
(females) 295 mg/kg/day, while the NOEL is 1000 mg Resorcinol/L (ca. 86 mg/kg/day (males), 126 mg/kg/day (females(premating and gestation),
and 225 mg/kg/day (females(lactation)) (F1 generation (males) 93 mg/kg/day and (females) 126 mg/kg/day.
Although Resorcinol was known to be readily absorbed and eliminated, blood Resorcinol levels could be detected in some animals in the 3000 mg/L
group. Decreased colloid in the thyroid histopathology, although a non-adverse effect in this study, was observed only in the 3000 mg/L group F0
males. Therefore, the effects of Resorcinol have been appropriately evaluated in this study.
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.