Registration Dossier
Registration Dossier
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EC number: 202-439-5 | CAS number: 95-65-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The available studies for the repeated dose toxicity of 3,4-DMP are documented in literature publications. No study details are available and most likely they have been conducted under non GLP- and non Guideline conditions because no information in this respect can be found in the study. The documentation is by far not sufficient to evalute the results. The time period of the study is significantly different from that required according to the GLP-Regulation.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicological Studies of Shale Oils, Some of Their Components and Commercial Products
- Author:
- Veldre, I.A.; Janes, H.J.
- Year:
- 1 979
- Bibliographic source:
- Environ. Health Perspect. 30; 141-146
- Reference Type:
- secondary source
- Title:
- 3,4-Dimethylphenol
- Author:
- Database
- Year:
- 2 014
- Bibliographic source:
- Integrated Risk Information System (IRIS), US Environmental Protection Agency, www.epa.gov/iris/subst/0231.htm (17.11.2014)
Materials and methods
Test guidelineopen allclose all
- Guideline:
- other: Oral RfD Assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: subacute, chronic toxicity, method not specified.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,4-xylenol
- EC Number:
- 202-439-5
- EC Name:
- 3,4-xylenol
- Cas Number:
- 95-65-8
- Molecular formula:
- C8H10O
- IUPAC Name:
- 3,4-dimethylphenol
- Reference substance name:
- 3,4-DMP
- IUPAC Name:
- 3,4-DMP
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: white rats
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 Month
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.4 mg/kg bw
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
14 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- no data
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 14 mg/kg bw/d restlessness, unsteadiness, clonic tremor, pareses and paralysis of extremities, and death. No changes at 1.4 mg/kg bw/d
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 14 mg/kg bw/d restlessness, unsteadiness, clonic tremor, pareses and paralysis of extremities, and death. No changes at 1.4 mg/kg bw/d
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant changes at 14 mg/kg bw. No changes at 1.4 mg/kg bw/d
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- At 14 mg/kg bw/d significant changes of peripheral blood analyses, blood pressure, blood pressure after adrenalin injection
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Pathomorphological changes of internal organs; significant changes in SH groups in internal organs; at 14 mg/kg bw/d
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Pathomorphological changes of internal organs
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 1.4 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LOAEL
- Effect level:
- 14 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- not specified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Veldre and Janes (1979) reported a study where 3,4-dimethylphenol was administered orally to white rats for an 8-month period. No toxic effects were seen at 1.4 mg/kg/day (NOEL) but a dose of 14 mg/kg/day resulted in body weight, blood pressure and histopathological changes in internal organs (LOAEL).
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