Registration Dossier
Registration Dossier
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EC number: 284-892-9 | CAS number: 84989-04-8 The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: comparable to a guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- publication
- Title:
- Comparative toxicity of cresol isomers
- Author:
- Dietz DD, Levine BS, Sonawane RB, Rubenstein R, DeRosa C
- Year:
- 1 987
- Bibliographic source:
- the Toxicologists 7, 246 No.982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Sontag JM, Page NP, Saffotti U, NCI, DHEW Publication No (NIH)78-ß01Guidelines for Carcinogen Bioassay in small rodents
- Principles of method if other than guideline:
- Method: see section" any other information of materials and methods"
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- o-cresol
- EC Number:
- 202-423-8
- EC Name:
- o-cresol
- Cas Number:
- 95-48-7
- Molecular formula:
- C7H8O
- IUPAC Name:
- o-cresol
- Details on test material:
- IUCLID4 Test substance: other TS: o-cresol purity 99.5%
Constituent 1
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
- Age at study initiation: 5-6 weeks
- Fasting period before study: 24 hours
- Housing: individually
- Diet : ad libitum):
- Water : ad libitum):
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72
- Humidity (%): 50
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
test solution was produced on a weekly basis
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- during test week 1, 2, 4, 8 and 13 by
Enseco Inc, Cambridge MA and additionally by American BiogenicsCorporation, Decatur IL - Duration of treatment / exposure:
- 13 w
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 175, 600 mg/kg bw/day in corn oil
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 animals /sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: no
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for mortality and clinical signs
BODY WEIGHT: Yes
- Time schedule for examinations: day 1 and then weekly
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption
and body weight gain data: Yes , weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: during quarantine period and in test week 13
HAEMATOLOGY: CLINICA CHEMISTRY : Urinalysis Yes
- Time schedule for collection of blood: as baseline clinical pathology, at test week 7 (interim kill) at study termination
- How many animals: 10 rats/sex/dose
- Parameters checked : see section "additional iformation on materials and methods"
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see section " any other information on materials and method"
HISTOPATHOLOGY: Yes (see section"Any other information on materials and method" - Other examinations:
- no data
- Statistics:
- One-Way Analysis of Variance tests, Dunnett's t test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- see section: "Remarks on results "
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: >= 175 mg/kg bw/day animals revealed central nervous system depression and showed statistically significant reduction in body weight and body weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
600 mg/kg bw/day:
mortality 19/30 females and 9/30 males,
Body weight: reduction body weight of females were unaffected 600 mg/kg bw/d, males: significant during week 2 through 10 175 mg/kg bw/d, males: significant during week 2 Body weight gain 175 and 600 mg/kg bw/d reduction in body weight gain (males), slight decrease in food intake;
600 mg/kg bw/day, males and females, 175 mg/kg bw/d: 1 female d23 and 1 female d27
Treatment-related depression of the central nervous system:
lethargy, dyspnoe, tremor and/or convulsions, recovering
within 1 h after dosing
no effects on clinical chemistry, hematology, urinalyses parameters,
no treatment-related ophthalmic lesions,
no effects on organ weights, no treatment-related gross and histomorphologic lesions;
Applicant's summary and conclusion
- Executive summary:
According to Sontag JM, Page NP, Saffotti U, NCI, DHEW Publication No (NIH)78-ß01 Guidelines for Carcinogen Bioassay in small rodents) male and female rats were applied with 0, 50,175, 600 mg/kg bw/day by gavage for 13 weeks. The NOAEL is 50 mg/kg bw/day based on clinical signs and effects on body weights from 175 mg/kg bw /day onwards..
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