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Registration Dossier
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EC number: 219-397-9 | CAS number: 2431-50-7
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Original data not available
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- !SIDSP*
- Year:
- 1 993
- Bibliographic source:
- OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, 19, (1993)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,3,4-trichlorobut-1-ene
- EC Number:
- 219-397-9
- EC Name:
- 2,3,4-trichlorobut-1-ene
- Cas Number:
- 2431-50-7
- Molecular formula:
- C4H5Cl3
- IUPAC Name:
- 2,3,4-trichlorobut-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 1-Butene, 2,3,4-trichloro
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 25 months
- Frequency of treatment:
- 6h/d, 5d/w
- Post exposure period:
- no data
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.001 and 0.013 mg/L (0.2 and 2.0 ppm)
Basis:
other: Starting doses
- Remarks:
- Doses / Concentrations:
0.001 and 0.010 mg/L (0.2 and 1.5 ppm)
Basis:
other: After 12 weeks high dose was reduced
- No. of animals per sex per dose:
- 55
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- Inhalation exposure (6h/d, 5d/w for 25 months) to 1.5 ppm 2,3,4-trichlorobut-1-ene induced nasal tumors in Wistar rats.
CLINICAL SIGNS AND MORTALITY
high dose group: dyspnoea, signs of chronic respiratory disease, growth retardation, increased mortality
HAEMATOLOGY
no effects
CLINICAL CHEMISTRY
no effects
ORGAN WEIGHTS
high dose group: increased rel. lung weights
HISTOPATHOLOGY: NON-NEOPLASTIC
low dose group: inflammatory changes and non-neoplastic alterations of the olfactory epithelium;
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
high dose group: nasal neuroepitheliomas of olfactoneurogenic origin 27 % in males and 18 % in females, 3 % malignant nasal Schwannomas in males (control all these tumors 0 %)
low dose group: no nasal tumors
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 0.2 ppm
- Sex:
- male/female
- Basis for effect level:
- other: (0.001 mg/L)
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- LOAEC
- Effect level:
- 1.5 ppm
- Sex:
- male/female
- Basis for effect level:
- other: (0.010 mg/L) nasal neuroepitheliomas of olfactoneurogenic origin 27 % in males and 18 % in females, 3 % malignant nasal Schwannomas in males
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Any other information on results incl. tables
Freetext:
haematological and biochemical values not effected
1.5/2.0 ppm (at week 12 dose-level of 2.0 ppm was lowered
to 1.5 ppm up to week 83): dyspnoea, growth retardation,
increased mortality, increased rel. lung weights, signs of
chronic respiratory disease, nasal neuroepitheliomas of
olfactoneurogenic origin 27 % in males and 18 % in females,
3 % malignant nasal Schwannomas in males (control all these
tumors 0 %) 0.2 ppm: inflammatory changes and non-neoplastic
alterations of the olfactory epithelium; no nasal tumors
Applicant's summary and conclusion
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