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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: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
, reduced documentation level
Principles of method if other than guideline:
BASF-Test
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): Butylglykolacetat;
- Physical state: fluid;
- Analytical purity: not reported;
- Stability under test conditions: not reported;
- Storage condition of test material: not reported.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder, Hannover, Germany.
- Mean weight at study initiation: 194.2 g (males), 159.6 g (females)

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion containing Traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2; 20; 30 %

MAXIMUM DOSE VOLUME APPLIED: 2.25 ml/animal corresponding to 21.3 ml/kg b.w.

Doses:
0.2; 1.25; 1.6; 2.0; 2.5; 3.2; 6.4 mL/kg b.w. corresponsing to 188; 1175; 1504; 1880; 2350; 3008; 6016 mg/kg. Calculation using density of 0.94 g/cm³, 20 °C.
No. of animals per sex per dose:
5 (except for 188 mg/kg b.w.: 3 females, 2 males and 6016 mg/kg b.w.: 3 males, 2 females.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing was performed only at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes

Statistics:
No statistics were performed.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 880 mg/kg bw
Remarks on result:
other: Effect level was calculated using the density of 0.94 g/cm³. The original value in the study was 2.0 mL/kg b.w..
Sex:
female
Dose descriptor:
LD0
Effect level:
ca. 188 mg/kg bw
Remarks on result:
other: Effect level was calculated using the density of 0.94 g/cm³. The original value in the study was 0.2 mL/kg b.w..
Sex:
male
Dose descriptor:
LD0
Effect level:
ca. 1 504 mg/kg bw
Remarks on result:
other: Effect level was calculated using the density of 0.94 g/cm³. The original value in the study was 1.6 mL/kg b.w..
Mortality:
see table below
Clinical signs:
In summary: stagger, face-down position, narcotic, diuresis, blood in the urine, haemolysis, 2 -3 days after substance application the animals showed blood in the urine and a strong, reversible decrease in haemoglobin. Female rats were more sensitive to the treatment than male rats.
In detail:
6.4 mL/kg b.w.: 5 min after application: strong stagger and atonic, spasmodically abduction of the lower lip. After ca. one hour narcosis appeared. About 3 hours later, the animals began to excrete bloody urine. (Qualitative spectroscopic investigation shows: positive Oxy-Haemoglobin and negative Met-Haemoglobin).
3.2 - 0.2 mL/kg b.w.: weak stagger in both higher doses; no other symptoms. After ca. 2 hours, at the latest during the night following treatment, in all doses abnormal high amounts of urine were excreted, which contained - dependent on the dose - smaller to higher amount of blood. After 2 further days only traces of blood were detected. Additionally, the animals exhibited except of weak apathy no specific symptoms. Only in higher doses the appearance of the animals suggested anaemia.
Investigations of the blood showed a reduction of the haemoglobin content during the first 24 hours to 50 - 20 % of the amount in the beginning of the study. Within 7 days the animals recovered, but the haemoglobin content did not reach baseline. No abnormality was detected in the surviving animals after 2 - 5 days.
Body weight:
no data
Gross pathology:
Animals, that died: pale livers; in two animals enlarged kidneys were observed; urinary bladder with boody content; sacrificed animals: no abnormalities detected.
Other findings:
- Other observations: late death; females were more sensitive than males

Any other information on results incl. tables

Mortality

 

Dose

Concentration

Animals

Females

Males

Exitus

mL/kg

%

N

N

N

24h

48h

7 days

14 days

 

 

 

 

 

 

 

 

females

males

6.4

30

5

2

3

4

5

5

2

3

3.2

30

10

5

5

2

4

4

4

1

2.5

30

10

5

5

2

3

5

5

0

2.0

30

10

5

5

1

3

5

2

3

1.6

20

10

5

5

1

2

3

4

0

1.25

20

10

5

5

0

2

3

3

0

0.2

2

5

3

2

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance meets criteria for classification as harmful
Executive summary:

In a reliable acute toxicity study in male and female rats which follows the principles of a guideline study, an LD50 of1880mg/kg was obtained. On the basis of these results, the substance would be classified as harmful by the oral route of ingestion