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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
intraperitoneal
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Limited study design and reporting. Documentation insufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Bioassay of alkylhalides and nukleotide base analogs by pulmonary tumour response in strain A mice
Author:
Poirier, L.A., Stoner, G.D., Shimkin M.B.
Year:
1975
Bibliographic source:
Cancer Res., 35, 1411-1415 (1975)

Materials and methods

Principles of method if other than guideline:
Screening of production of lung adenomas in strain A mice following multiple injection of several alkyl halides and base analogs was investigated.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
purity at least 98%

Test animals

Species:
mouse
Strain:
other: A/Heston (A/He)
Sex:
male/female
Details on test animals or test system and environmental conditions:
- age: 6-8 weeks
- body weight: 17-19 g
- food: Purina laboratory chow ad libitum
- water: ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: tricaprylin
Details on exposure:
The test item was injected i.p. 3 times weekly for a total of 24 doses.
Duration of treatment / exposure:
8 weeks
Frequency of treatment:
3 times per week
Doses / concentrations
Remarks:
Doses / Concentrations:
12.9, 32, 65 mmol/kg bw
Basis:

No. of animals per sex per dose:
10
Control animals:
yes, concurrent no treatment
yes, concurrent vehicle
Details on study design:
Post-exposure period: 16 weeks
Positive control:
urethane

Examinations

Observations and examinations performed and frequency:
Body weight control every 2 days.
Sacrifice and pathology:
Investigation for lung tumours, gross and microscopic evaluation of  lungs, kidneys, intestine, liver, thymus, spleen, salivary and endokrine  glands.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Histopathological findings: neoplastic:
effects observed, treatment-related
Details on results:
Mortality:
12.9 mmol/kg bw: 9/20, 32.4 mg/kg bw: 9/20, 65 mg /kg bw: 8/20;
controls: untreated: 1/30, vehicle control: 1/15, urethan 1/20

Carcinogenicity: ambiguous
Lung tumours: 6 animals of the high and mid dose group and 7 animals of the  low dose group had lung tumours.
The lung tumour rate in controls was 20% for untreated, 35.7% for vehicle controls and 100% for urethane.  A slight but significant increase in lung tumours per mouse was reported  in the treated animals at the high and mid dose level.

No other changes were reported.

Applicant's summary and conclusion

Conclusions:
The increase in lung tumours due to tert-Butyl chloride remains questionable in the light of variable background incidences and high mortality in the dosed groups.