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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Disturbances in the development of the progeny of rats subjected to the influence of hydrogen chloride
Author:
Pavlova T.E
Year:
1976
Bibliographic source:
Byull. Eksp. Biol. Med., 82, 866-868.

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
see source
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen chloride
EC Number:
231-595-7
EC Name:
Hydrogen chloride
Cas Number:
7647-01-0
Molecular formula:
ClH
IUPAC Name:
chloride
Test material form:
gas

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
Doses 450 mg/m3 (0.45 mg/L) , 1h
Duration of treatment / exposure:
From 12 days prior to mating period untill three month after parturition
Duration of test:
From 12 days prior to mating period untill three month after parturition
Doses / concentrations
Dose / conc.:
450 mg/m³ air
Control animals:
not specified

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
effects observed, treatment-related
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
effects observed, treatment-related
Immunological findings:
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
not examined
Description (incidence and severity):
Hemorrhagic oedema of the lungs; one third of the animals died of severe dyspnea and cyanosis; the surviving animals showed functional disorders of the lungs, the kidneys and the liver.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Hemorrhagic oedema of the lungs; one third of the animals died of severe dyspnea and cyanosis; the surviving animals showed functional disorders of the lungs, the kidneys and the liver.
Histopathological findings: neoplastic:
no effects observed
Other effects:
effects observed, treatment-related
Description (incidence and severity):
maternal toxicity: Hemorrhagic oedema of the lungs; one third of the animals died of severe dyspnea and cyanosis; the surviving animals showed functional disorders of the lungs, the kidneys and the liver. embryotoxicity: Mainly the male offspring suffered from functional disorders of the lungs, the kidneys and the liver. Mortality of offspring was significantly higher compared to controls

Maternal developmental toxicity

Number of abortions:
effects observed, treatment-related
Pre- and post-implantation loss:
effects observed, treatment-related
Total litter losses by resorption:
not examined
Early or late resorptions:
not examined
Dead fetuses:
effects observed, treatment-related
Changes in pregnancy duration:
not examined
Changes in number of pregnant:
not examined
Other effects:
effects observed, treatment-related
Description (incidence and severity):
maternal toxicity: Hemorrhagic oedema of the lungs; one third of the animals died of severe dyspnea and cyanosis; the surviving animals showed functional disorders of the lungs, the kidneys and the liver. embryotoxicity: Mainly the male offspring suffered from functional disorders of the lungs, the kidneys and the liver. Mortality of offspring was significantly higher compared to controls
Details on maternal toxic effects:
maternal toxicity: Hemorrhagic oedema of the lungs; one third of the animals died of severe dyspnea and cyanosis; the surviving animals showed functional disorders of the lungs, the kidneys and the liver. embryotoxicity: Mainly the male offspring suffered from functional disorders of the lungs, the kidneys and the liver. Mortality of offspring was significantly higher compared to controls

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEC
Effect level:
450 mg/m³ air
Based on:
test mat.
Basis for effect level:
clinical signs
Remarks on result:
not determinable due to adverse toxic effects at highest dose / concentration tested

Results (fetuses)

Fetal body weight changes:
effects observed, treatment-related
Description (incidence and severity):
at high maternal toxicity
Reduction in number of live offspring:
effects observed, treatment-related
Description (incidence and severity):
at high maternal toxicity
Changes in sex ratio:
not examined
Changes in litter size and weights:
effects observed, treatment-related
Description (incidence and severity):
at high maternal toxicity
Changes in postnatal survival:
not examined
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed
Other effects:
not examined
Details on embryotoxic / teratogenic effects:
Details on embryotoxic / teratogenic effects:
There was an increase in mortality among the progeny of rats exposed at day 9 of pregnancy but not in those exposed before mating (31.9 ± 9.2% vs 5.6 ± 3.7% in the control group). Reduced body weight gain was recorded at 4 weeks of age in the latter group (males: 66.8 ± 2.4 g vs 75.5 ± 2.3 g in controls; females: 63.2 ± 3.1 g vs 72.2 ± 1.7 g in controls).
Other parameters affected at 2 months of age are summarized in Table A6.8.1/01-2, and were related to the kidney function. These included increased diuresis in male young rats of both experimental groups but reduced in young females of group whose mothers were treated before mating, and decrease of protein content of urine in male young rats whose mothers were exposed at day 9 of pregnancy.
Results obtained in 3-month young rats are summarized in Table A6.8.1/01-3 and again showed effects on kidney function, limited to the male young rats, with increased chlorides and decrease protein concentration in urine in rats whose mothers were exposed on day 9 of pregnancy or before mating, respectively.
The hypoxic test showed no disturbance of lung function in either group.
The additional exposure to HCl caused changes in absorption of vital dye by the lung of male animals of both groups, and reduced excretion of hippuric acid in urine in male animals whose mothers were exposed before mating. The relative kidney weight was also increased in both groups

Effect levels (fetuses)

Remarks on result:
not determinable due to adverse toxic effects at highest dose / concentration tested

Overall developmental toxicity

Key result
Developmental effects observed:
yes
Lowest effective dose / conc.:
450 mg/m³ air (analytical)
Treatment related:
no
Relation to maternal toxicity:
developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
Dose response relationship:
no
Relevant for humans:
no

Applicant's summary and conclusion