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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1981)
Qualifier:
according to guideline
Guideline:
other: EEC Directive 79-831, Annex V, Part B: Methods For The Determination Of Toxicity, 4.1.1 Acute Toxicity Orally
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glyoxal
EC Number:
203-474-9
EC Name:
Glyoxal
Cas Number:
107-22-2
Molecular formula:
C2H2O2
IUPAC Name:
oxalaldehyde
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Code HF 0001

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark, at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Glyoxal as 40% aqueous solution is stable for 6 months

OTHER
- Impurities (identity and concentrations): acetic acid, formic acid, glycolic acid, glyoxylic acid, nitric acid, formaldehyde, acetaldehyde, glycol aldehyde, ethylene glycol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Weight at study initiation: males, 190.3 g (182 - 203 g); females, 177.9 g (165 - 193 g)
- Fasting period before study: 16 hours prior and 2 hours after treatment
- Housing: five animals per cage, in Makrolon cages
- Diet (e.g. ad libitum): rat feed (Rattendiaet Altromin 1324), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): housing in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- The concentration of test substance in vehicle was 25 % as w/v, for each dose level
- The application volume was 8, 12.6 and 20 mL/kg bw for the 2000, the 3150 and the 5000 mg/kg bw dose level, respectively
Doses:
2000, 3150 and 5000 mg/kg bw of test substance containing 40% a.i., i.e. 800, 1260 and 2000 mg/kg bw of active ingredient
No. of animals per sex per dose:
10 animals/sex/dose
Control animals:
no
Details on study design:
- The treatment was followed by a 14-day post -exposure period of observation;
- The animals were observed for mortality and clinical symptoms of toxicity several times, as recommended by the OECD guideline;
- Body weight was recorded once a week;
- Animals that died during the 14-day observation period were subjected to necropsy and were examined for gross pathology;
- At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy.
Statistics:
The determination of the LD50 was based on the Probit Analysis

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 300 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
3 660 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
2 960 mg/kg bw
Mortality:
- In the 2000 mg/kg bw group:  0/5 males 1/5 females (i.e. 10% mortality)
- In the 3150 mg/kg bw group:  2/5 males 2/5 females (i.e. 40% mortality)
- In the 5000 mg/kg bw group:  4/5 males 5/5 females (i.e. 90% mortality)
- All cases of death occurred between 70 minutes and 24 hours following dosing.
Clinical signs:
- Clinical symptoms indicative of toxicity were seen in all groups and both sexes.
- Following treatment, the animals showed decreased spontaneous activity, decreased respiration rate, increased water consumption, uncoordinated gait, squatting position, and retracted abdomen and flanks.
- At the higher dose levels (3150 and 5000 mg/kg bw) some symptoms indicative of acute neurotoxicity were reported that included diminished to absent startle response, toe pinch response and corneal response; furthermore, the animals showed prone and side position and often suffered from increased respiratory rate.
- After a couple of hours, those rats that survived showed a long-legged position and were very jumpy; they recovered, however, within 3 days following treatment and showed no more symptoms of intoxication thereafter.
Body weight:
Body weight gain was inconspicuous
Gross pathology:
- Necropsy of animals that died: partly firm small and large intestines filled with a colorless liquid, some cases of reddening of the stomach mucosa, spotted liver and dark discoloration of the adrenals, some cases of increased blood content in the lung, and some cases of grey-pink discoloration of the lung were reported.
- Necropsy of animals that survived and were sacrificed at the end of the observation period: no abnormalities were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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