Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed prior to the implementation of GLP and OECD Guidelines, but is in compliance with the principles described in OECD Guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Glyoxylic Acid, 50 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breeding
- Age at study initiation: young adult
- Weight at study initiation: 80-96 g
- Fasting period before study: 16 hours
- Housing: plastic cages
- Diet: standard diet ALTROMIN 1324, Altrogge Lage/Lippe, Germany ; ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
1250, 2000, 3200, 5000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were recorded one a week
- Necropsy of survivors performed: yes
Statistics:
Statistics were performed using the inverse cumulative distribution function (ProbitFunction according to LINDER and WEBER).
Confidential intervalls were claculated according to the merhod of CAVALLI-SFORZA.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 528 mg/kg bw
Based on:
test mat.
Mortality:
1250 mg/kg bw 0/10 ;
2000 mg/kg bw 2/10 ;
3200 mg/kg bw 8/10 ;
5000 mg/kg bw 10/10
Clinical signs:
Animals that died showed a ragged breathing, disturbance of equilibrium and cramps and were convulsing in ventral position.
Body weight:
No data
Gross pathology:
In animals that died a pale, white coloured small intestine was noted.
Necropsy revealed no abnormalities in animals that survived.

Applicant's summary and conclusion

Executive summary:

In this acute oral toxicity study (Hoechst AG, Pharma Forschung Toxikologie, 1975), groups of fasted, young adult Wistar rats (10/dose) were given a single oral dose of Glyoxylic Acid 50 % in water at doses of 1250, 2000, 3200 or 5000 mg/kg bw and observed for 14 days. In animals that died a pale, white coloured small intestine was noted. Necropsy in animals that survived revealed no abnormalities. The oral LD50 value was calculated to be 2528 mg/kg bw.