Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July - October 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline for the testing methode is mentioned in the report. Nevertheless the test result seems to be reliable as the observation period is also stated to be 14 days and the testing procedure as well as the choice of doses seems to be reasonable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acetoguanamine
- Appearance/physical state/colour: white powder

Test animals

Species:
rat
Strain:
other: Wistar derived
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: colony of TNO institute
- Weight at study initiation: 150 to 260 g (males) and 108 to 208 g (females)
- Fasting period before study: 16 hours
- Stock diet and tap water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: a 20 % (w/v) suspension of Acetoguanamine in a 5 % aqueous solution of carboxy methyl cellulose

MAXIMUM DOSE VOLUME APPLIED:
15 ml of the 20 % suspension of Acetoguanamine in a 5 % aqueous solution of carboxy methyl cellulose for each kg of body weight.
Doses:
10, 11, 12, 13, 14 and 15 ml of the 20 % suspension of Acetoguanamine in a 5 % aqueous solution of carboxy methyl cellulose for each kg of body weight.
No. of animals per sex per dose:
five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
no statistics reported

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2.74 other: g/kg
95% CL:
2.57 - 2.92
Mortality:
Some of the animals died within three hours after the treatment with Acetoguanamine.
Deaths occurred up to two days after dosing.
Clinical signs:
One hour after the treatment all animals became sluggish and showed severe diarrhoea.
But the survivors recovered rapidly and looked quite healthy again at the end of the first week.
Body weight:
no data
Gross pathology:
No abnormalities were seen in these animals at autopsy.
Other findings:
no data

Any other information on results incl. tables

TABEL 1: The mortality in the test animals of the various dose groups after the treatment with Acetoguanamine.

dose

mortality

ml 20 % solution/kg

g test substance/kg

number

%

males

females

10

2.0

0/5

0/5

0

11

2.2

0/5

2/5

20

12

2.4

1/5

0/5

10

13

2.6

0/5

2/5

20

14

2.8

2/5

4/5

60

15

3.0

3/5

5/5

80

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value of Acetoguanamine was calculated to be 2.74 g/kg body weight with 2.92 and 2.57 as 95 % confidence limits. Because of this reason Acetoguanamine is not classified as acute oral toxic.
Executive summary:

An acute oral toxicity test with Acetoguanamine was performed. No guideline for the testing methode is mentioned in the report. Nevertheless the test result seems to be reliable as the observation period is also stated to be 14 days and the testing procedure as well as the choice of doses seems to be reasonable.

On the basis of some preliminary observations the following doses were given as as one single dose to groups of five male and five female rats: 2.0, 2.2, 2.4, 2.6, 2.8, 3.0 g test substance / kg bw.

The animals were observed for a 14 -day period. Then the survivors were killed and examined grossly. With the obtained study results the LD50 of Acetoguanamine was calculated to be 2.74 g/kg body weight. Because of this reason Acetoguanamine is not classified as acute oral toxic.