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EC number: 203-400-5 | CAS number: 106-46-7
- 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
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP conditions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,4-dichlorobenzene
- EC Number:
- 203-400-5
- EC Name:
- 1,4-dichlorobenzene
- Cas Number:
- 106-46-7
- Molecular formula:
- C6H4Cl2
- IUPAC Name:
- 1,4-dichlorobenzene
- Test material form:
- other: solid
- Details on test material:
- purity 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: (P) males 8 weeks; females 11 weeks
- Housing: one male and one female for mating, then individual
- Diet ad libitum
- Water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- P: males received the test substance for 77 days females for 14 days prior to mating, Then the animals received the tstsubstance upt and including the pups(F2) of the F1 generation
- Details on mating procedure:
- Start of mating procedure: Day 78 (p-generation); Day 204 (F1 generation).
End of mating procedure was 14 days (p-generation, respectively 30 days later (F1 generation). - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- After administration of the test substance for 77 days (male animals), 14 days (female animals) all animals were mated monogamic within the individual dosegroups and the administration of test substance was continued.
After the succeeded birth the dams were treated with the test material until the 21. day of life of the pups.
24 of these pups per sex and group remained in the experiment and were treated with the test substance until the elimination out of the experiment. After approx. 80 days the monogamic mating procedure was executed within this F1 generation to produce F2 generation. - Frequency of treatment:
- daily
- Details on study schedule:
- see: table in ´Any other materials and methods´.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 30, 90, 270 mg/kg/day, 7days/week
Basis:
- No. of animals per sex per dose:
- 24 rats/dose/sex
- Control animals:
- yes
- Details on study design:
- After administration of the test substance for 77 days (male animals), 14 days (female animals) all animals were mated monogamic within the individual dosegroups and the administration of test substance was continued.
After the succeeded birth the dams were treated with the test material until the 21. day of life of the pups.
24 of these pups per sex and group remained in the experiment and were treated with the test substance until the elimination out of the experiment. After approx. 80 days the monogamic mating procedure was executed within this F1 generation to produce F2 generation. - Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- for clinical signs and mortality , behavior during mating and birth of the litter, body weight development, food consumption
- Litter observations:
- number of pups per litter, gender, body weight, survival, and changes during early development such as eyes, and ears. from day 21 e.g. reflexes , orientation
- Postmortem examinations (parental animals):
- sacrifice of all animals, investigationmacroscopically and microscopically of reproductive organs,liver, spleen, kidneys including organ weight determination, and macroscopically all organs with obvious changes
- Postmortem examinations (offspring):
- only macrospcopical investigation if found dead in cage
all offsprings all organs which demonstated macroscopically changes - Statistics:
- arithmetic mean, variance analysis followed by Schffe-test, H-test of Kruskal and Wallis or U-test accorcing to Wilcoxon, Mann and Whitney,Chi-square test
- Reproductive indices:
- Fertility index, Gestation index
- Offspring viability indices:
- survival index (day 4), lactation index (day 21)
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
P-Generation body weight comparable to controls; F1 (high dose group reduced body weight development compared to controls
P-and F1-generation : no effects of test substance on Fertility Index and Gestation Index
Pathology:
P-generation:high dose and F1-generation high dose and mid dose:
males: increased relative and absolute weights of liver and kidneys, decreased spleen weights, histopathological changes in kidney but not in livers
Effect levels (P0)
open allclose all
- Dose descriptor:
- other: NOAEL (fertility)
- Effect level:
- 270 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL for fertility was estimated to be 270 mg/kg/day;
- Remarks on result:
- other: Generation: P and F1 (migrated information)
- Dose descriptor:
- other: NOAEL (general toxicity)
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: the NOAEL of the P and F1 parents was found to be 90 mg/kg/day based on kidney changes at the highest test dose;
- Remarks on result:
- other: Generation: P and F1 (migrated information)
- Dose descriptor:
- other: NOAEL (offspring)
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: at 90 mg/kg/day toxicity in pups were seen associated with slight behavioral changes in pups from 90 mg/kg/day: the NOAL for these developmental effects is estimated at 30 mg/kg/day.
- Remarks on result:
- other: Generation: F1 and F2 (migrated information)
Results: F1 generation
Details on results (F1)
reduced number of live pups at birth, increased number of pups deceased between days of lactation 1 to 4 and 5 to 21, reduced mean body weight of pups, retarded erection of ears and retarded of eye opening, reduced percentage of pups with positive draw-up test, dry and squamous skin and ring tails in pups followed by loss of the tail
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The NOAEL for fertility was estimated to be 270 mg/kg/day; the NOAEL of the F0 and F1 parents was found to be 90 mg/kg/day; at 90 mg/kg/day toxicity in pups were seen associated with slight behavioral changes in pups from 90 mg/kg/day: the NOAEL for these developmental effects is estimated at 30 mg/kg/day.
Applicant's summary and conclusion
- Executive summary:
p-Dichlorobenzene, dissolved in olive oil, was administered orally to two generations of rats to detect possible effects of the test substance on reproduction (OECD guideline 416 and GLP). The doses used for the three test substance groups were 30, 90 and 270 mg/kg bw/day. Olive oil was applied to one group of male and female rats that served as control group. Dose volume was 1 ml per kg body weight for all groups.
In both generations the test substance had no effects on: time between beginning of mating and evidence of copulation,
time of gestation, fertility index, gestation index, percentage of dams with only dead pups, total number of pups at birth,
percentage of pups with positive ear reflex, graspring reflex and orientation reaction, absolute and relative weights of
female kidneys, spleens and livers.
In the mid and/or high dose groups the test substance had an effect on number of live pups at birth (reduced), number of pups deceased between days of lactation 1 to 4 and 5 to 21 (increased), mean body weight of pups (reduced), erection of ears
and opening of eyes (retarded), percentage of pups with positive draw up test (reduced), alterations of the skin (dry,
squamous) and ring tails in pups, absolute and relative organ weights of adult males (livers and kidneys: increased;
spleens: reduced).damages to the kidneys in mild-and high-dose groups of both generations are also probably test
substance related.
At the low dose of 30 mg test substance per kg body weight no effects of the test substance were detected on fertility parameters of rats; the next higher dose of 90 mg/kg already caused massive damage in pups.
The NOAEL for fertility was estimated to be 270 mg/kg/day; the NOAEL of the F0 and F1 parents was found to be 90 mg/kg/day; at 90 mg/kg/day toxicity in pups were seen associated with slight behavioral changes in pups from 90 mg/kg/day: the NOAEL for these developmental effects is estimated at 30 mg/kg/day.
Overall, the NOAEL for fertility was estimated to be 270 mg/kg bw/day, the NOAEL(genral toxicity) for P and F1 parents was found to be 90 mg/kg bw/dayand the NOAELis estimated at 30 mg/kg bw.
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