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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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:
1981
Reference Type:
secondary source
Title:
No information
Author:
!SIDSP*
Year:
1993
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

Constituent 1
Chemical structure
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

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