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EC number: 220-701-7 | CAS number: 2871-01-4
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1974
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- This no GLP compliant study used the test item in formulation with other hair dyes instead of pure recommended by REACh regulation. Raw data including food consumption was not provided.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic Toxicity, Teratologic and Reproduction Studies with Hair Dyes
- Author:
- T. Wernick, B.M. Lanman, and J.L. Fraux
- Year:
- 1 975
- Bibliographic source:
- Toxicol. Appl. Pharmacol., 32: 450-460
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A fertility and reproductive performance study was performed on Sprague-Dawley CD rats. Sixty males and 120 females were divided into six groups. Levels of 0, 1950 and 7800 ppm of a hair dye composite material containing 15 hair dye substances which were incorporated in the diet and provided ad libitum. The concentration of HC Red No. 3 in the composite material was 0.02%. The average doses were calculated as 0,19.5 and 97.5 mg/kg bw/d which corresponds to doses of 0,3.9 and 19.5 µg/kg . In part I of the study the females received the basal diet from week 8 prior to mating through the weaning of their litters. The males siring these litters were fed the test diets from week 8 prior to mating and during the mating period. In part II of the study males received the basal diet from week 8 prior to mating and during mating while the females received the test diets from week 8 prior to mating and during gestation and lactation. Uterus was examined for number and distribution of embryos, presence of empty implantation sites, number of embryos undergoing resorption. Necropsy was performed on female which had not deliver litter. Duration of pregnancy was recorded, litters were examined for numbers of of live and stillborn pups and gross abnormalities.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-(4-amino-2-nitroanilino)ethanol
- EC Number:
- 220-701-7
- EC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Cas Number:
- 2871-01-4
- Molecular formula:
- C8H11N3O3
- IUPAC Name:
- 2-(4-amino-2-nitroanilino)ethanol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Dye Base composite was derived from Clairol, Inc. No batch was given
FORM AS APPLIED IN THE TEST (if different from that of starting material)
The test item was used at 0.02% in formulation with : Acid Orange 3 (0.24%), H.C. Blue No. 2 (1.63%), Celliton Fast Navy Blue BRA (0.64%), 2-Nitro-p-phenylenediamine (0.24%), 4-Nitro-a-phenylenediamine (0.16%), 2-amino-4-nitrophenol (0.05%), HC Yellow No.5 (0.05%), HC Yellow No. 4 (0.31%), Disperse Violet 11 (0.40%), Disperse Blue 1 (0.61%), Disperse Black 9 (0.13%), HC Blue 1 (1.54%), HC Yellow No.2 (0.28%), HC Yellow No. 3 (0.65%), Lauramide DEA (20.22%), Imino-bis propylamine (9.64%), Cellulose ether (17.94%), Citric acid (16.02%), BHT (1.61%), Sodium m-nitrobenzene sulfonate (2.25%), TEA-Dodecylbenzene sulfonate (1.61%), Monoethanolamine (22.42%), Perfume (0.67%), Perfume (0.67%)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: from Charles River Breeding Laboratories, Inc
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: not specified
- Weight at study initiation: (P) Males: 240-280 g; Females: 180-220 g
- Fasting period before study: no
- Housing: not specified
- Diet (e.g. ad libitum): Basal diet Purina laboratory chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: not specified
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency):Prepared twice weekly
- Mixing appropriate amounts with (Type of food): basal diet of Purina laboratory chow
- Storage temperature of food: not specified - Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: 10 days
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- After 10 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): individually in cage - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Part 1 : 8 weeks before mating and males were treated before and during the mating
Part 2 : Females were treated 8 weeks prior mating and during gestation , male were treated with basal chow diet only - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 1 950 ppm (nominal)
- Dose / conc.:
- 7 800 ppm (nominal)
- No. of animals per sex per dose:
- 10 males and 20 females per conditions for each part of the study.
- Control animals:
- yes
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- Uterus was examined for number and distribution of embryos, presence of empty implantation sites, number of embryos undergoing resorption. Pregnant females, unproductive males, duration of pregnancy were recorded
- Postmortem examinations (parental animals):
- Necropsy was performed on female which had not deliver litter.
- Postmortem examinations (offspring):
- litters were examined for numbers of of live and stillborn pups and gross abnormalities.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 7 800 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- reproductive performance
Any other information on results incl. tables
Table 1 :Summary of results
Concentration in diet(%) |
|
0 |
0.195 |
0.78 |
0 |
0.195 |
0.78 |
|
|
Part 1 |
|
Part 2 |
|
|
|
|
Summary of mating performance |
|
|
|
|
|
|
mg/kg/day(average) |
|
0 |
86 |
351 |
0 |
124 |
554 |
No. Males |
|
10 |
10 |
10 |
10 |
10 |
10 |
No.Females |
|
20 |
20 |
20 |
20 |
20 |
20 |
No.Pregnancies |
|
17 |
19 |
13 |
19 |
18 |
19 |
Femalefertilityindex |
|
85 |
95 |
65 |
95 |
90 |
95 |
No.Unproductivemales |
|
1 |
0 |
2 |
0 |
0 |
0 |
Malefertilityindex |
|
90 |
100 |
80 |
|
|
|
|
Summary of treated male induced pregnancies terminated at the 13th day of gestation |
|
|
|
|
|
|
No.Pregantssacrified |
|
8 |
9 |
8 |
9 |
8 |
9 |
Average No. Ofembryos |
|
|
|
|
|||
Lefthorn |
|
5.3 |
6 |
5.7 |
6.2 |
6.3 |
7.3 |
righthorn |
|
6.6 |
6.1 |
6.3 |
6 |
5.4 |
5.8 |
total |
|
11.9 |
12.1 |
12 |
12.2 |
11.7 |
13.1 |
No.Emptyimplant sites |
|
0 |
0 |
0 |
1 |
0 |
0 |
No.Undergoingresorption |
|
7 |
5 |
6 |
3 |
2 |
6 |
No.Abnormalities |
|
0 |
0 |
0 |
0 |
0 |
0 |
No.Litterswithresorption |
|
5 |
5 |
4 |
3 |
2 |
4 |
|
Summary of treated male induced pregnancies allowed to litter normally |
|
|
|
|||
No.Females |
|
9 |
10 |
5 |
10 |
10 |
10 |
Average length of gestation (days) |
21.6 |
21.7 |
21.4 |
21.7 |
21.4 |
21.1 |
|
Gestation index |
|
100 |
100 |
100 |
100 |
100 |
100 |
Average No. Pups per litter |
10.5 |
11.1 |
10.8 |
10.5 |
11.6 |
11.6 |
|
Percent alive atBirth |
|
94 |
98 |
98 |
95 |
91 |
96 |
Percent alive at 4days |
|
92 |
98 |
94 |
88 |
78 |
88 |
Precentalive at 21Days |
|
89 |
98 |
93 |
87 |
77 |
86 |
Viability index |
|
98 |
99 |
96 |
92 |
86 |
92 |
lactation index |
|
98 |
100 |
98 |
99 |
98 |
98 |
average bodyweight of pups at birth |
6.5 |
6 |
6.4 |
6.5 |
6.3 |
6.1 |
|
average bodyweight of pups at 4 days |
10.6 |
9.3 |
9.7 |
10.1 |
9.6 |
9.6 |
|
average bodyweight of pups at 21 days |
46.8 |
48.1 |
48.2 |
47.1 |
49.3 |
44.3 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of the study, the test item at 0.02% with other hair dyes did not led to alteration of female or male fertility and reproductive parameters. However, this study cannot be used for classification. This no GLP compliant study used the test item in formulation with other hair dyes instead of pure recommended by REACh regulation. Raw data including food consumption was not provided.
- Executive summary:
The purpose of this no GLP-compliant study was to assess the potential reprotoxic effect of the test item in formulation with other hair dyes in Sprague Dawley rats exposed by food.
A fertility and reproductive performance study was performed on Sprague-Dawley CD rats. Sixty males and 120 females were divided into six groups. Levels of 0, 1950 and 7800 ppm of a hair dye composite material containing 15 hair dye substances which were incorporated in the diet and provided ad libitum. The concentration of HC Red No. 3 in the composite material was 0.02%. The average doses were calculated as 0, 19.5 and 97.5 mg/kg bw/d which corresponds to doses of 0, 3.9 and 19.5 µg/kg bw/d HC Red No. 3. In part I of the study the females received the basal diet from week 8 prior to mating through the weaning of their litters. The males siring these litters were fed the test diets from week 8 prior to mating and during the mating period. In part II of the study males received the basal diet from week 8 prior to mating and during mating while the females received the test diets from week 8 prior to mating and during gestation and lactation. Uterus was examined for number and distribution of embryos, presence of empty implantation sites, number of embryos undergoing resorption. Necropsy was performed on female which had not deliver litter. Duration of pregnancy was recorded, litters were examined for numbers of of live and stillborn pups and gross abnormalities.
There were no dose related significant differences in any of the parameters examined which included male and female fertility, length of gestation, numbers of females with resorption sites, live pups per litter, pup bodyweight, and pup survival. The female fertility index in the high dose group in the Part 1 and the average pup weight in the high dosage group in Part 2 were lower than the control values, but the differences were not statistically significant at the 95% confidence level. At the dietetary concentrations fed, there were no effects on food consumption and body weight gains of either males or females. No abnormal pups were seen upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days.
Under the experimental conditions of the study, the test item at 0.02% with other hair dyes did not led to alteration of female or male fertility and reproductive parameters. However, this study cannot be used for classification. This no GLP compliant study used the test item in formulation with other hair dyes instead of pure recommended by REACh regulation. Raw data including food consumption was not provided.
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