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EC number: 201-969-4 | CAS number: 90-15-3
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1988
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Poor study design (poor test substance, details of negative control group is not stated and a viral infection resulted in poor reproductive performance in all groups
Data source
Reference
- Reference Type:
- publication
- Title:
- Multigeneration Reproduction and Carcinogenicity Studies In Sprague-Dawley Rats Exposed Topically to Oxidative Hair-Colouring Formulations Containing p-Phenylenediamine and Other Aromatic Amines
- Author:
- Burnett, C. M., and Goldenthal, E. I
- Year:
- 1 988
- Bibliographic source:
- Food and Chemical Toxicology 26,467-474
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: the solution was applied topically twice weekly throughout the growth, mating, gestation and foetal viability indices and body weights were evauated and these were compared with the values for the three concurrent control groups.
- Short description of test conditions: The generation F0 was exposed until they were 100 days old and after they were mated. The generation F1a were used in a carcainogenicity study. The generation F0 was re-mated and 20 mals and 20 female of the generation F1b were exposed untiil they were 100 days old and after ther were mated to produce the F2a and F2b generation. the F2b generation, after a selection, were mated to produce F3 generation. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 1-naphthol
- EC Number:
- 201-969-4
- EC Name:
- 1-naphthol
- Cas Number:
- 90-15-3
- Molecular formula:
- C10H8O
- IUPAC Name:
- naphthalen-1-ol
- Test material form:
- solid
- Details on test material:
- No data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: haur dye formulation n°7043
- Expiration date of the lot/batch: No data
- Purity test date: No data
- Purity : 0.5%
- other consituents : toluenediamine sulphate (6%), m-aminophenol (0.7%),p-aminophenol (1%), 4-nitro-p-phenylenediamine (0.25%), oleic acid (15%), isopropanol (10%), glycerine (4.5%), proylene glycol (9%), sodium sulphit (0.2%), ammonia 29% (9%), water (ad 100%).
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Preliminary purification step (if any): No
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 100-00 g
- Fasting period before study: No data
- Housing: individual
- Diet : ad libitum (Purina Laboratroy Chow)
- Water: ad libitum
- Acclimation period: No data
DETAILS OF FOOD AND WATER QUALITY: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):no data
- Air changes (per hr) No data:
- Photoperiod (hrs dark / hrs light): yes (no details)
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: Hydrogen peroxid (6%)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- 0.5 ml of the test formulation mixing with an equal volume of 6% hydrogen peroxide
- Prepared fresh for each application
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Concentration in vehicle: 0.25%
- Lot/batch no. (if required): obtained from commercial suppliers
- Purity: No data - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 15 days
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- If unsuccessful pairing : No data
- After successful mating each pregnant female was caged individualy and were allowed to deliver naturally - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- F0 :until they were 100 days old
F1 : until they were 100 days old - Frequency of treatment:
- Twice weekly
- Details on study schedule:
- - F1 parental animals not mated until 11 weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were 21 days of age.
- Age at mating of the mated animals in the study:: 100 days
Doses / concentrations
- Dose / conc.:
- 0.5 other: %
- No. of animals per sex per dose:
- 40 per sex per dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: commercial product
- Other: the rats of each sex were randomly assigned to nine groups of 40 animals of each in such a way as to achieve comparable mean group body weight. - Positive control:
- No
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION : Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data - Oestrous cyclicity (parental animals):
- No
- Sperm parameters (parental animals):
- No
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: Yes
- If yes, maximum of 10 pups/litter; excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 ] offspring: number and sex of pups, pharmacological effects, llive births, postnatal mortality, weight
GROSS EXAMINATION OF DEAD PUPS: No
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY: No
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY: No - Postmortem examinations (parental animals):
- No data
- Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at 21 days of age.
- These animals were subjected to postmortem examinations : Yes for 5 males and 5 females.
GROSS NECROPSY No data
HISTOPATHOLOGY / ORGAN WEIGTHS
These tissues were prepared for microscopic examination : adrenals, colon, heart, ileum, jejunum, kidneys, liver, lungs, ovaries, uterus and skin. - Statistics:
- Yes (each treatment group with each of the three separate control groups by sex)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- Consisted of mild dermatitis seen intermittently throughout the treatment period.
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Fertility, gestation, survival and live birth indices and the mean numbers weaned and mean weaning weights for each litter in each generation were comparable amonth the test and control group.
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- Consisted of mild dermatitis seen intermittently throughout the treatment period.
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not examined
- Description (incidence and severity):
- Fertility, gestation, survival and live birth indices and the mean numbers weaned and mean weaning weights for each litter in each generation were comparable amonth the test and control group.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- Consisted of mild dermatitis seen intermittently throughout the treatment period.
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- Consisted of mild dermatitis seen intermittently throughout the treatment period.
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Applicant's summary and conclusion
- Conclusions:
- A multi-generation reproduction toxicity study was carried out by using a formulation containing 0.5% 1-Naphthol. Because of the poor study design (poor test substance, details of negative control group is not stated and a viral infection resulted in poor reproductive performance in all groups) the study it was considered to be of limited value only
- Executive summary:
A multi-generation reproduction toxicity study was carried out by using a formulation containing 0.5% 1-Naphthol. Because of the poor study design (poor test substance, details of negative control group is not stated and a viral infection resulted in poor reproductive performance in all groups) the study it was considered to be of limited value only
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