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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable BASF Test, basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF test:
The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted
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:
- Physical state: liquid
- Analytical purity: approx. 25%

Test animals

Species:
mouse
Strain:
other: the mice were designed as Kisselegg mice
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
The mice received single i.p. injections of the test substance in a concentration range of 0.5 to 20% aqueous solution.
Doses:
12.2, 25, 32, 40, 50, 100, 200 and 1600 mg/kg bw
No. of animals per sex per dose:
Five/sex/group
Control animals:
no
Details on study design:
The animals were observed over a period of 14 days for mortality and clinical symptoms of toxicity, and were subjected to necropsy and gross pathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 50 mg/kg bw
Remarks on result:
other: (original value: 50 mm3/kg bw)
Mortality:
The cumulative mortalities over the 14 days observation period were as follows:
- 0% at 12.5 mg/kg bw;
- 10% at 25 mg/kg bw;
- 10% at 32 mg/kg bw;
- 40% at 40 mg/kg bw;
- 60% at 50 mg/kg bw;
- 100% at each of 100, 200 and 1600 mg/kg bw.
Clinical signs:
- The mice displayed a series of clinical signs of toxicity, which included accelerated respiration, dyspnea, aggressiveness, convulsion and staggering;
- The symptoms appeared immediately after injection;
- The symptoms were more severe in the animals that died, i.e. at the higher dose levels (200 and 1600 mg/kg bw);
- The animals that survived were free of symptoms after 12 days.
Gross pathology:
- Necropsy of animals that died: pathological examination not feasible because of putrescence;
- Necropsy of animals sacrificed at test ending: gross pathological examination mainly revealed adhesions within the abdominal cavity.

Applicant's summary and conclusion