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EC number: 220-036-2 | CAS number: 2611-82-7
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- A study of the embyotoxixity of the food colour Ponceau 4R in rats
- Author:
- Meyer O. et al.
- Year:
- 1 975
- Bibliographic source:
- Toxicology 5, pp. 201-207
Materials and methods
- Principles of method if other than guideline:
- Embryotoxicity study in rats by gavage from day 1 to 20 of the gestation period. Foetuses were removed on day 21.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Acid Red 018
- IUPAC Name:
- Acid Red 018
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 weeks
- Housing: steelwire cages
ENVIRONMENTAL CONDITIONS
- Temperature: 24 ± 1 °C
- Humidity: 60 ± 5 %
- Air changes: 8 per hr
- Photoperiod: electric light from 4 p.m. to 4 a.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: test substance dissolved in distilled water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1
- Length of cohabitation: 5 days
- Proof of pregnancy: the presence of plug was checked every evening (day 0) and morning (day 1) - Duration of treatment / exposure:
- From day 1 to 20.
- Frequency of treatment:
- Once per day.
- Duration of test:
- On day 21, rats were sacrificed.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 4 000 mg/kg bw/day (actual dose received)
- Control animals:
- yes, concurrent no treatment
- other: positive control (250 mg aspirin)
- Details on study design:
- - Dose selection rationale: based on range-finding test in which even the highest dose was tolerated without any deleterious effect.
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: on day 21
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: weight of intact uterus, number of corpora lutea, of implantations and of foetuses, alive or dead. Weight gain of the damns, sex ratio of foetuses and preimplantation loss were calculated. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: yes
- Number of corpora lutea (CL): yes
- Number of implantations: yes
- Preimplantation loss: yes
- Postimplantation loss: yes
- Number of foetuses, dead or alive, and sex ratio: yes - Fetal examinations:
- - External examinations: yes, all per litter
- Soft tissue examinations: yes, half per litter
- Skeletal examinations: yes: half per litter - Statistics:
- Student's t-test was performed on weight gain of the dams, mean weight of the intact uteri, preimplantation loss, and postimplantation loss. Critical values for testing two-by-two tables were performed on number of young with fourteenth rib(s) and Wilcoxon Ranks test on litter size.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Weight gain indicated a slight tendency to decrease with increasing doses.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 4 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- changes in number of pregnant
- changes in pregnancy duration
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- maternal abnormalities
- necropsy findings
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
Results (fetuses)
- Fetal body weight changes:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Skeletal and visceral malformations were sporadic and not dose-related. The incidence of retarded ossification and subcutaneous hemorrhage was distributed equally among the groups.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 4 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Reproduction data
substance | dose mg/kg bw/d | pregnancy rate | mean values per pregnant dam | % loss | dams with resorptions | |||||
corpora lutea | implantations | resorptions | viable fetuses | preimplantations ± s.d. | post-implantations ± s.d. | no. | % | |||
test subs. | 0 | 14/15 | 11.5 | 9.2 | 1.0 | 8.2 | 22.1 ± 27.0 | 27.1 ± 28.6 | 5 | 35.7 |
1000 | 13/15 | 12.3 | 10.3 | 0.7 | 9.6 | 17.2 ± 21.6 | 21.4 ± 20.4 | 6 | 46.2 | |
2000 | 13/15 | 11.0 | 9.2 | 0.5 | 8.6 | 15.4 ± 22.9 | 27.1 ± 30.8 | 5 | 38.5 | |
4000 | 12/15 | 11.5 | 9.3 | 1.3 | 8.1 | 20.6 ± 33.3 | 37.0 ± 38.4 | 7 | 58.3 | |
aspirin | 250 | 7/10 | 10.7 | 9.7 | 7.6 | 2.1 | 12.3 ± 35.7 | 81.0 ± 30.5 | 7 | 100 |
Litter data
substance | dose mg/kg bw/d |
viable young | male/female | mean pup weight g ± s.d. | |
total | mean | ||||
test subs. | 0 | 115 | 8.2 | 1.158 | 3.25 ± 1.08 |
1000 | 125 | 9.6 | 1.182 | 3.01 ± 0.61 | |
2000 | 112 | 9.3 | 0.933 | 3.40 ± 0.86 | |
4000 | 97 | 8.1 | 1.077 | 3.04 ± 0.67 | |
aspirin | 250 | 15 | 2.1 | 0.909 | 2.27 ± 0.58 |
Skeletal and internal malformations
substance | dose mg/kg bw/d | extra ribs | foetuses with other skeletal malformations | number examined | findings (number) | ||
litter | foetus | litters | foetuses | ||||
test subs. | 0 | 3/14 | 4/57 | 1 scoliosis, 1 kyphosis | 13 | 58 | hypoplasia of diaphragma (1), aplasia of left internal genital organ (1) |
1000 | 6/13 | 10/65 | 0 | 13 | 60 | ||
2000 | 4/12 | 5/58 | 0 | 12 | 54 | bilateral anophthalmia (1), unilateral anophthalmia (1), diaphragmatic hernia (1) | |
4000 | 5/12 | 5/52 | 0 | 10 | 45 | ||
aspirin | 250 | 2/3 | 5/8 | 0 | 3 | 7 |
Applicant's summary and conclusion
- Conclusions:
- Under test condtions, no maternal toxicity or embryotoxicity was noted.
- Executive summary:
Method
Embryotoxicity study in SPF Wistar rats, dosed by gavage from day 1 to 20 of gestation in doses of 0, 1000, 2000 and 4000 mg/kg bw/day, dissolved in distilled water. Foetus were removed on day 21 day. Aspirin at dose of 250 mg/kg bw/day was used as control.
Results
No effect was seen on: number of corpora lutea (CL), implantations, foetuses dead or alive, gross malformations, skeletal and internal malformations, weight of foetuses. The highest dose of 4000 mg/kg bw/d was identified as NOAEL.
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