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: Meets generally accepted scientific standards, well documented and acceptable for assessement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dimethyl sulphate
- Physical state: liquid

Test animals

Species:
rat
Strain:
other: US
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: US rats
- Age at study initiation: young adult animals were used
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tragacanth (polysaccharide)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: animals received emulsions of 0.5-20% test substance with tragacanth by oral gavage
- Amount of vehicle (if gavage): 25-1600 µl/kg bw
Doses:
25, 50, 64, 80, 100, 125, 200 and 1600 µl/kg body weight (corresponding to appr. 33.3, 66.5, 85.1, 106.4, 133.0, 166.3, 266.0 and 2128.0 mg/kg body weight assuming a density of 1.33 g/ml)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: animals were observed and examined for clinical signs of toxicity at least daily
- Necropsy of survivors performed: yes; deceased animals and those sacrificed at the end of the observation period were necropsied
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 was approximated

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 85.1 - < 133 mg/kg bw
Remarks on result:
other: 20/20 animals died in the 133.0 mg/kg body weight dose group, 9/20 (8 males) died in the 106.4 mg/kg body weight dose group and 3/20 (2 males) died in the 133.0 mg/kg body weight dose group.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 106.4
Sex:
female
Dose descriptor:
LD50
Effect level:
> 85.1 - < 106.4
Sex:
male
Dose descriptor:
LD50
Effect level:
> 106.4 - < 133.2
Mortality:
First deaths were noted 1 h after dosing. All deaths occurred within 24 hours (see Table 1). No deaths occurred in the 50 µl/kg-group within the 7-day observation period.
Clinical signs:
Restlessness, irregular and accelerated breathing was reported for all dose levels. Dyspnoe, convulsions, apathy, hunched posture was observed at 100 µl/kg and higher doses.
Gross pathology:
Section findings, not discriminated according to dose level: Gastrectasy, decomposition, terminal lung oedema.

Any other information on results incl. tables

Table 1: Mortality

 

Dose level

(µl/kg bw)

Mortality during the 7-day observation period

Males

Females

Total

1600

10/10

10/10

20/20

200

10/10

10/10

20/20

125

6/10

10/10

16/20

100

10/10

10/10

20/20

80

1/10

8/10

9/20

64

1/10

2/10

3/20

50

0/10

0/10

0/20

25

0/10

0/10

0/20

Applicant's summary and conclusion