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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1976
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Major deficiences : unknow purity and specification of 1-naphthol (commercial product), no information on test animals and environmental conditions/ type of coverage/ observations. And there is only one concentration of exposition.

Data source

Reference
Reference Type:
publication
Title:
Teratology and Percutaneous Toxicity Studies on Hair Dyes
Author:
Burnett, C., Goldenthal, E. I., Harris, S. B., Wazeter, F. X., Strausberg, J., Kapp, R., and Voelker, R.
Year:
1976
Bibliographic source:
J. Toxicol. Environ. Health, 1: 1027-1040

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: a hair dye formulation containing 1-naphthol was tested for systemic effects following application to groups of 12 New Zealand White Rabbits
- Short description of test conditions: 1-naphthol was tested by topical application twice weekly for 13 weeks to group of 12 New Zealand White Rabbits.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No data (commercial product)
- Expiration date of the lot/batch: No data
- Purity test date: No data

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

TREATMENT OF TEST MATERIAL PRIOR TO TESTING No

FORM AS APPLIED IN THE TEST Solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- 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):No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: 6% hydrogen peroxide
Details on exposure:
TEST SITE
- Area of exposure: thoracic-lumbar
- % coverage: No data
- Type of wrap if used: No (the rabbit were restrained in holding stocks)
- Time intervals for shavings or clipplings: the hair at the site of application on the back and sides of each rabbit was clipped short throughout the study

REMOVAL OF TEST SUBSTANCE
- Washing (if done): shampooed, rinsed, dried
- Time after start of exposure:1 hour

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml/kg
- Concentration (if solution): 0.25%
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Amount(s) applied (volume or weight with unit): volume 1:1
- Concentration (if solution): 6%
- Lot/batch no. (if required): No data
- Purity: No data

USE OF RESTRAINERS FOR PREVENTING INGESTION: No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
Twice weekly
Doses / concentrations
Dose / conc.:
0.5 other: %
No. of animals per sex per dose:
12
Control animals:
yes, concurrent no treatment
Details on study design:
- Dose selection rationale: No data
Positive control:
No data

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

DERMAL IRRITATION (if dermal study): No data

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION: No data

FOOD EFFICIENCY:No data

WATER CONSUMPTION:No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Time schedule for collection of blood:0, 3, 7 and 13 weeks
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals:No data
- Parameters checked : blood count, methemoglobin, fasting blood sugar, blood urea nitrogen, alkaline phosphatase and serum glutamic oxaloacetic transminase.

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 0, 3, 7 and 13 weeks
- Animals fasted: No data
- How many animals:No data
- Parameters checked :

URINALYSIS: Yes
- Time schedule for collection of urine: 0, 3, 7 and 13 weeks
- Metabolism cages used for collection of urine: No data
- Animals fasted:No data
- Parameters checked : color, pH, albumin, glucose, occult blood and microscopic elements

NEUROBEHAVIOURAL EXAMINATION: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (organ-body weight ratios were determined for liver, kidneys, adrenals, heart, thyroid, spleen and brain)

HISTOPATHOLOGY: Yes (spleen, stomach, duodenum, colon, liver, gall, bladder, adrenals, nerve, eyes, pancreas, kidneys, urinary bladder, ovaries, testes, bone, bone marrow, hearth, lung, thyroid, brain and skeletal muscle)
Statistics:
Analysis of variance F test and Student's test.

Results and discussion

Results of examinations

Clinical signs:
not examined
Dermal irritation:
not specified
Mortality:
not examined
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Neuropathological findings:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 0.5 other: %
Based on:
test mat.
Sex:
male/female

Applicant's summary and conclusion

Conclusions:
Hair dye formulation containing 0.5% of 1 -naphthol was applied to rabbits twice weekly for 13 weeks. There was no evidence of systemic toxicity
Executive summary:

Hair dye formulation containing 0.5% of 1 -naphthol was applied to rabbits twice weekly for 13 weeks. There was no evidence of systemic toxicity