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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The original publication is in Japanese, with abstract and tables written in English; an English translation of the paper exists. The reported data were scientifically acceptable.

Data source

Reference
Reference Type:
publication
Title:
Acute and subacute toxicity studies and local irritation study of glutaraldehyde.
Author:
Uemitsu N, Kawasaki H, Furuhashi T, Miyoshi K, Ohtaka T, Nomura A, Hasegawa T, Shimizu Y, Nakazawa M
Year:
1976
Bibliographic source:
Oyo Yakuri 12(l): 11-32, (Japanese publication & English translation)

Materials and methods

GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaral
EC Number:
203-856-5
EC Name:
Glutaral
Cas Number:
111-30-8
Molecular formula:
C5H8O2
IUPAC Name:
glutaraldehyde
Test material form:
liquid
Specific details on test material used for the study:
Glutaraldehyde 25% aq. solution, from Johnson and Johnson Far East Inc.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The males had an initial mean body weight of about 210 g/animal
The females had an initial mean body weight of about 140 g/animal

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
35 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Dose / conc.:
1 mg/kg bw/day
Dose / conc.:
5 mg/kg bw/day
Dose / conc.:
25 mg/kg bw/day
Dose / conc.:
125 mg/kg bw/day
No. of animals per sex per dose:
Each group consisted of 10 animals/sex.
Control animals:
yes, concurrent no treatment
Details on study design:
The experimental series consisted of 5 groups, four treated groups and one control group; the control group received physiological saline.
Each group consisted of 10 animals/sex.

Examinations

Observations and examinations performed and frequency:
The animals were regularly observed for mortality and clinical symptoms of toxicity.
Body weight changes and food consumption were recorded.
A series of hematological parameters including red and white blood cells counts, hematocrit, hemoglobin and differential white blood cells counts was
examined, as well as a series of clinical-chemical parameters including GOT, GPT, ALP, LDH, Total protein, cholesterol, glucose, N-urea, bilirubin, albumin, Na, K, Cl.
Urinalysis also was performed.
Sacrifice and pathology:
At the end of the experiment the animals were sacrificed for the purpose of necropsy.
They were subjected to gross pathology and the absolute and relative weights of a series of organs including pituitary, brain, thyroid, thymus, lung, heart, liver, kidney, adrenals, spleen, testes, epididymis and prostate were determined.
- A series of organs/tissues was fixed with formaline and sections were prepared and stained with hematoxylin/eosin for further histopathological examinations.

Results and discussion

Results of examinations

Mortality:
no mortality observed
Description (incidence):
- No treatment-related mortality was reported.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
- A decrease in body weight gain was reported for the males of the 125 mg/kg bw group; in fact at the end of the experimental period, the treated males of the 125 mg/kg bw group hat a mean body weight of ca. 310 g /animal versus ca. 375 g for the control males (initial body weight for all males about 210 g/animal). The males of the 25 mg/kg bw group also showed a slight decrease in body weight gain when compared to controls, reaching about 340 g/animal at the end of the experiment. Body weight gain of the treated females was inconspicuous and within the range of controls (ca. 220 - 230 g/animal after 35 days, versus ca. 140 g/animal at test starting).
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
- Food consumption of the 125 mg/kg bw males was reduced when compared to controls; in fact, over a period ranging from day 7 of treatment to day 14, food consumption of the treated rats decreased from about 22 g/day to ca. 17 g/day (reduction of ca. 23%). Starting from day 21 of treatment, a slight increase in mean food consumption was noticed (ca.19 g/day towards the end of the treatment period). Food consumption for the treated females was within control range.
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
- At both test doses of 25 and 125 mg/kg bw, the animals showed signs of inflammation and necrosis at the injection sites. The inflammation was accompanied by changes in following hematological parameters:
- Increase in white blood cells count: males: 127 +/-23 *10 E+2 cells/mm3 at 25 mg/kg bw and 181 +/-55 *10 E+2 cells/mm3 at 125 mg/kg bw, versus 91 +/-18 *10 E+2 cells/mm3 in control; females: 155 +/-37 *10 E+2 cells/mm3 at 25 mg/kg bw and 176 +/-32 *10 E+2 cells/mm3 at 125 mg/kg bw, versus 99 +/-13 *10 E+2 cells/mm3 in control.
- Decrease in hematocrit: males: 38.2% +/-1.7 at 25 mg/kg bw and 36.9% +/- 2.2 at 125 mg/kg bw, versus 47.2% +/- 1.6 in control; females: 39.5% +/-2.3 at 25 mg/kg bw and 37.2% +/- 0.9 at 125 mg/kg bw, versus 44.5% +/- 1.4 in control.
- Decrease in hemoglobin: males: 12.8 +/- 0.6 g/dl at 25 mg/kg bw and 12.1 +/- 0.9 g/dl at 125 mg/kg bw, versus 15.3 +/- 0.4 g/dl in control; females: 11.7 +/- 0.7 g/dl at 25 mg/kg bw and 11.1 +/- 0.3 g/dl at 125 mg/kg bw, versus 14.8 +/- 0.6 g/dl in control.
- Decrease in lymphocytes: males: 75.8% +/- 7.8 at 25 mg/kg bw and 64.6% +/- 10.3 at 125 mg/kg bw, versus 89.1% +/- 4.6 in control; females: 74.1% +/- 11.2 at 25 mg/kg bw and 76.8% +/- 9.8 at 125 mg/kg bw, versus 89.1% +/- 4.5 in control.
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
- Excepted for an increase in serum N-urea (125 mg/kg bw females: 26.5 mg/dl +/- 5.9 versus 17.8 mg/dl +/- 4.6 for control females) the considered clinical-chemical were inconspicuous.
Urinalysis findings:
no effects observed
Description (incidence and severity):
The urinary parameters also were inconspicuous, excepted for an increase in total protein content.
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
- Organ weights were inconspicuous.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
- Necropsy and histopathological examination revealed hypertrophy of white pulps in the spleen, thymus atrophy and atrophy of the glandular epithelium of the prostate; the renal tubuli in the kidneys showed degeneration.
- Excepted for slight cell infiltrations and edema at the injection sites, the animals of the lowest test dose (1 mg/kg bw) showed no effects

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion