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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given, peer reviewed, study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Gaseous formaldehyde and hydrogen chloride induction of nasal cancer in the rat.
Author:
Albert RE et al.
Year:
1982
Bibliographic source:
J Natl Cancer Inst 68, 579-604
Reference Type:
publication
Title:
Carcinogenicity of formaldehyde and hydrogen chloride in rats.
Author:
Sellakumar AR et al.
Year:
1985
Bibliographic source:
Toxicol Appl Pharmacol 81, 401-406 cited in OECD SIDS Sulfuryl chloride
Reference Type:
secondary source
Title:
Hydrogen chloride (CASRN 7647-01-0)
Author:
US EPA
Year:
1995
Bibliographic source:
Integrated Risk Information System. US Environmental Protection Agency (http://www.epa.gov/iris/subst/0396.htm)
Reference Type:
secondary source
Title:
Sulfuryl chloride, CAS No.:7791-25-5, SIAR
Author:
OECD
Year:
2002
Bibliographic source:
UNEP publications

Materials and methods

Principles of method if other than guideline:
Method: no data
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Hydrogen chloride
EC Number:
231-595-7
EC Name:
Hydrogen chloride
Cas Number:
7647-01-0
IUPAC Name:
chloride
Details on test material:
Test substance: hydrogen chloride
Purity: 99.0% grade (Matheson Gas Products, East Rutherford, N.J.)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure (if applicable):
whole body
Details on exposure:
overall gas mixture flow rate of 4 liters/minute
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
lifetime
Frequency of treatment:
6 hours/day and 5 days/week during lifetime
Doses / concentrations
Remarks:
Doses / Concentrations:
ca. 0.015 mg/L (10 ppm)
Basis:

Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
29 % mortality after 588 days (control: 28 %).
Mortality:
mortality observed, treatment-related
Description (incidence):
29 % mortality after 588 days (control: 28 %).
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
No significant change when compared with controls.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Complete necropsy was performed on all animals, with particular attention given to the respiratory tract. Histological sections were prepared from the nasal cavity (one lateral section from each side of the head), lung (one section from each lobe), trac
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Totally, 19 and 25 tumours were found in treated and control rats, respectively. Type and incidence of tumours were not significantly different. No nasal tumours were observed in both treated and control animals.
Details on results:
Result (carcinogenicity): negative

Any other information on results incl. tables

The Albert et al. (1982) study, discussed in detail by Sellakumar et al. (1985), reported data from a chronic
inhalation exposure study in rats. One hundred male Sprague-Dawley rats were exposed to 10 ppm hydrogen chloride
(HCl) for 6 hours/day, 5 days/week (duration-adjusted concentration = 2.5 mg/m3) for their lifetimes. All animals
were observed daily, weighed monthly, and allowed to die naturally or killed when moribund. Complete necropsy was
performed on all animals, with particular attention given to the respiratory tract. Histological sections were prepared
from the nasal cavity (one lateral section from each side of the head), lung (one section from each lobe), trachea,
larynx, liver, kidneys, testes, and other organs where gross pathological signs were present. However, Sellakumar et al.
(1985) did not discuss histopathological events in organs other than the respiratory tract. HCl-exposed animals showed
no differences in body weights or survival when compared with air controls. The data indicated 62/99 exposed animals
with epithelial or squamous hyperplasia in the nasal mucosa (location not specified) vs. 51/99 in the concurrent control
group. Incidence of squamous metaplasia was 9 and 5 in the exposed and control rats, respectively. There was a 24 %
incidence of hyperplasia of laryngeal-tracheal segments in HCl-exposed rats (larynx 2/22, trachea 6/26) vs. 6 % in the
controls. The authors did not make any comments concerning the severity of these changes. Based on these results, the
US EPA (1995) gave 10 ppm as LOAEL [LOAEL(HEC) = 6.1 mg/m3).

Applicant's summary and conclusion