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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: Comparable to guideline study with acceptable restriction (pre-GLP study).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test. The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyldiaethanolamin
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 180 - 260 g; female: 144 - 210 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
200, 1600, 3200, 4000, 5000, 6400 ml/kg bw (208, 1664, 3328, 4160, 5200, 6656 mg/kg bw; conversion into mg/kg is based on the density d= 1.04 g/cm3 -according to BASF internal data)
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
A test group consisting of 10 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 680 mg/kg bw
Remarks on result:
other: Conversion into mg/kg is based on the density d= 1.04 g/cm3
Mortality:
The test substance caused systemic toxicity including mortality in a dose dependent manner.
See details in remarks on results.
Clinical signs:
3328 - 6656 mg/kg bw: immediately squatting posute, ruffled fur and gasping. On the next day some animals showed bloody eyes and noses, ruffled fur and gasping.
1664 mg/kg bw: immediately squatting posute, ruffled fur and gasping.
Body weight:
no data
Gross pathology:
Animals that died: all animals had smeared snouts and urogenital tracts. 11xdroopy gastrointestinal tract with bloody content;
Sacrificed animals: 8x bronchitis and bronchiectasis.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw)  Gender  Conc.(%)   1h  24 h  48 h   7 days              
 6656  male 30  0/10  7/10  7/10  7/10              
 6656  female 30  0/10  10/10  10/10  10/10              
5200  male 30  0/10  3/10 3/10  3/10              
5200  female 30  0/10  10/10  10/10  10/10              
4160  male 30  0/10  2/10  2/10  2/10              
4160  female 30   0/10   5/10   6/10   6/10                
3328  male 30   0/10   1/10   1/10   1/10                
3328  female 30   0/10    0/10   0/10   0/10                
1664  male 20    0/10    0/10   0/10   0/10                
1664 female   20  0/10   0/10   0/10   0/10                
208  male  2   0/10   0/10   0/10  0/10                 
208  female  2   0/10   0/10   0/10   0/10                

The test substance caused systemic toxicity including mortality in a dose dependent manner.

Applicant's summary and conclusion