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EC number: 284-896-0 | CAS number: 84989-07-1 The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.
- 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:
- toxicity to reproduction
- Remarks:
- other: combined repeated dose and reproduction/developmental study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 July 2004 - 17 Sept 2004
- Reliability:
- 1 (reliable without restriction)
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 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Xylenols isomer mixture
- IUPAC Name:
- Xylenols isomer mixture
- Details on test material:
- - Name of test material (as cited in study report): 2,5-xylenol (CAS 95-87-4), 3,4-xylenol (CAS 95-65-8), 2,4-xylenol (CAS 105-67-9), 3,5-xylenol (CAS 108-68-9), 2,3-xylenol (CAS 526-75-0), 2,6-xylenol (CAS 576-26-1). Test substancec was a mixture of xylenol isomers.
- Analytical purity: 99.74%
- Isomers composition: 2,5-xylenol (CAS 95-87-4): 16.4 mole %, 3,4-xylenol (CAS 95-65-8): 16.9 mole %, 2,4-xylenol (CAS 105-67-9): 22.7 mole %, 3,5-xylenol (CAS 108-68-9): 11.1 mole %, 2,3-xylenol (CAS 526-75-0): 18.2 mole %, 2,6-xylenol (CAS 576-26-1): 14.7 mole %.
- Lot/batch No.: 20NOV2003
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on mating procedure:
- Male and female rats were pair 1:1 and cohabited for a maximum of 14 days. Female rats with spermatozoa observed in a msear of the vaginal conents and/or a copulatory plug in situ were considered to at GD 0 and then individually housed.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Minimum of 28 days (14 days of dosing prior to cohabitation).
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
analytical conc.
30, 100, 300 mg/kg/day
- No. of animals per sex per dose:
- 10 male and 10 females/group
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 mg/kg bw/day
- Based on:
- other:
- Sex:
- male/female
- Basis for effect level:
- other: Due to clinical observations (urine-stained fur, increased kidney, liver and ovarian relative weight).
- Dose descriptor:
- NOAEL
- Remarks:
- Reproductive
- Effect level:
- >= 245 mg/kg bw (total dose)
- Based on:
- other:
- Sex:
- male/female
- Basis for effect level:
- other: Whilst a reduced mating frequency was observed, this was within the laboratory's historical control range, therefore not considered biologically relevant.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
All rats survived the treatment. In males, urine stained fur was observed at the 245 mg/kg/day level. Body weight gain and food consumption were unaffected by treatment. Mating frequency was reduced at the 245 mg/kg/day level. Neurotoxicity was not observed during the study and there were no treatment related effects observed at gross necropsy or histopathologically. Urine staining of the fur was observed in females at the 245 mg/kg/day level. F1 animals showed no treatment related clinical or necropsy signs. Haematology, clinical pathology and FOB parameters were unaffected.
Relative weights of the kidney, liver and ovaries were observed to be increased in the 245 mg/kg/day treatment group,
Decreased mating and fertility indices were reported at the highest dose level (245 mg/kg bw) in the combined repeated dose toxicity and reproduction/developmental toxicity screening test. The number of female rats that mated was reduced from 100% in the control group (10/10) to 80% at 245 mg/kg bw (8/10) but the difference was not significantly different. The historical control value was reported as 97.6% over the period 1992-2002 but as no range was given this figure was of limited value. Following a request to Argus addition al historical control data were provided on 19 April 2010. The information provided showed fertility data for individual years from 1992 to 1997 giving the range as well as the mean values and these are shown in Table 1.
Table 1: Fertility index for studies conducted in Crl:CD(SD) Rats
Year |
Average |
Minimum |
Maximum |
No of studies |
1992 |
94.1 |
80.0 |
100.0 |
4 |
1993 |
89.5 |
80.0 |
100.0 |
9 |
1994 |
90.5 |
66.7 |
100.0 |
17 |
1995 |
93.8 |
89.7 |
100.0 |
5 |
1996 |
93.1 |
84.0 |
100.0 |
13 |
1997 |
91.7 |
71.4 |
100.0 |
23 |
1992 - 1997 |
91.7 |
66.7 |
100.0 |
71 |
It is clear from the historical control data that fertility in the mixed xylenols study was within the historical control range in several years during the period from 1992-1997 which corresponds to the time when the mixed xylenols study was conducted.
As the reduced fertility at 245 mg/kg bw was not statistically significant and was within the historical control range, this effect is considered not to be related to treatment and the NOAEL for reproductive effects in this study should be ≥ 245 mg/kg bw.
Applicant's summary and conclusion
- Conclusions:
- The test substance mixed xylenol isomers was administered to rats by oral gavage at 0, 30, 100 and 245 mg/kg/day. The general toxicological No Observable Adverse Effect Level was shown to be 100 mg/kg/day.
The SD determined that the reproductive NOAEL was found to be 245 mg/kg/day due to reduced mating at 245 mg/kg/day, however following request of the historical control data from the laboratory, the reduction in mating frequency to 80% was within the laboratory's historical vehicle control data for this period.
Therefore the reproductive NOAEL is considered to be in excess of 245 mg/kg/day
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