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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
5 rats per sex were dosed with 200 - 3200 mg/kg bw and observed up to 14 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethanolamine substance-No. XV/306
- no further data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: US rats

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 and 20%
- Amount of vehicle (if gavage): 5, 6.25, 8.0, 10.0, 12.5 ccm/kg bw
Doses:
200, 800, 1000, 1250, 1600, 2000, 2500, 3200 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females;
2000 and 2500 mg/kg bw dosing groups: only 5 males tested each
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology, histopathology

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 100 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 500 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 600 mg/kg bw
Mortality:
200 to 1000 mg/kg dosing group: no death occurred;
1250 mg/kg dosing group: 5/5 females died on day 4 (2 animals) and on day 5 (3 animals)
1600 mg/kg dosing group: 5/5 females died on day 5
2000 mg/kg dosing group: no death occurred
2500 mg/kg dosing group: 2/5 males died on day 5
3200 mg/kg dosing group: 5/5 females died within 48 hours; 5/5 males died within 7 days (3/5 died within 48 hours)
Clinical signs:
dyspnea, tumbling, staggering gait, twitches, saltation convulsions, dyspnoea, abdominal lateral position, scrubby coat, anacasm to chew,
Body weight:
nothing abnormal reported
Gross pathology:
hydrothorax, local adhesions of the gut; signs of irritation on gastro-intestinal tract

Any other information on results incl. tables

Survival of rats after oral application of various doses of diethanolamine

Dose (mg/kg)

Concentration in vehicle (%)

No. of animals

sex

No. of animals died within

1h

24h

48h

7d

14d

3200

20

5

males

1/5

1/5

3/5

5/5

-

5

females

0/5

3/5

5/5

5/5

-

2500

20

5

males

0/5

0/5

0/5

2/5

2/5

females

2000

20

5

males

0/5

0/5

0/5

0/5

0/5

females

0/5

0/5

0/5

0/5

-

1600

20

5

males

0/5

0/5

0/5

5/5

-

5

females

0/5

0/5

0/5

0/5

-

1250

20

5

males

0/5

0/5

0/5

0/5

-

5

females

0/5

0/5

0/5

5/5

-

1000

20

5

males

0/5

0/5

0/5

0/5

-

5

females

0/5

0/5

0/5

0/5

-

600

20

5

males

0/5

0/5

0/5

0/5

-

5

females

0/5

0/5

0/5

0/5

-

200

2

5

males

0/5

0/5

0/5

0/5

-

5

females

0/5

0/5

0/5

0/5

-

Applicant's summary and conclusion