Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only abstract available, study in Russian.

Data source

Reference
Reference Type:
publication
Title:
Experimental data for establishing an MPC for ethylene chlorohydrin in the air of manufacturing premises
Author:
Koviazin VG
Year:
1971
Bibliographic source:
Gig Truda i Prof Zabolevaniya 15: 54-56

Materials and methods

GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details

Test animals

Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
virgin females

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
other: presumably whole body
Vehicle:
other: no data
Details on inhalation exposure:
No details
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 months
Frequency of treatment:
5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1, or 10 mg/m³
Basis:
no data
No. of animals per sex per dose:
totally 45 rats (presumably 15 rats per dose group)
Control animals:
yes
Details on study design:
Post-exposure period: 1 month
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: yes

BODY WEIGHT: Yes
- Time schedule for examinations: no data

FOOD CONSUMPTION: no data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes

No details were given.
Sacrifice and pathology:
"pathomorphological examination", no further details
Other examinations:
no
Statistics:
no data

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:
not specified
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
effects observed, treatment-related
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
From the first month, the experimental groups (presumably both treatment groups) showed a significant difference from the control in body weight increase. Symptoms of central nervous system were observed (no data about dose). At 3 and 4 months, the following changes were noted: a decrease in serum beta-globulins, an increase in the albumin-globulin coefficient, an increase in the relative liver weight and a significant decrease in the urinary excretion of hippuric acid under a sodium benzoate load (no data about dose group). After a 1-month recovery period, a pathomorphological examination of the internal organs revealed significant dystrophic changes to the parenchymatous organs at 10 mg/m³ (authors comment: liver involvement was observed). There were no pathological changes found histologically in the other two groups.

No further data available.

Effect levels

Dose descriptor:
NOAEC
Sex:
female
Remarks on result:
not determinable
Remarks:
no NOAEC identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In a subchronic inhalation study in rats toxic effects were reported but no clear allocation was given on the dose level (1 or 10 mg/m³) except pathomorphological effects which are restricted to the high dose level.
Executive summary:

The reliability of the study is not assignable (only abstract available).

Female rats were exposed 5 days per week via inhalation to 0, 1, or 10 mg/m³. The post exposure observation period was 1 month. The following effects were reported: decreased body weight gain, symptoms of central nervous system, decrease in serum beta-globulins, increase in albumin-globulin coefficient, increase in the relative liver weight and significant decrease in the urinary excretion of hippuric acid under a sodium benzoate load. However, no data were given on the dose causing these effects. Pathomorphological examination of the internal organs revealed significant dystrophic changes to the parenchymatous organs at 10 mg/m³ (authors comment: liver involvement was observed). There were no pathological changes found histologically in the other two groups.

Conclsuion: In a subchronic inhalation study in rats toxic effects were reported but no clear allocation was given on the dose level (1 or 10 mg/m³) except pathomorphological effects which are restricted to the high dose level.