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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 well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Method: BASF-Test. In principle, the methods described in OECD Guideline 401 were used.
5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7- to 14-day study period. The clinical signs and findings were reported in summary form.
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): Ethylviolett fluessig

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
316, 464, 681, 1000 mg/kg bw, corresponding to ca. 126, 186, 272, 400 mg/kg bw EVA.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weights

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 410 mg/kg bw
Based on:
other: preparation containing ca. 40% ethylviolet acetate, ca. 17% acetic acid, ca. 17% confidential component and ca. 26% water
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 234 mg/kg bw
Based on:
other: registered substance
Clinical signs:
Poor general state with staggering in some animals, atony, paresis, narcotic-like state with absence of pain reflex, tremors, spastic gait, diarrhea and salivation and occasionally substantial loss of weight at the beginning.
Body weight:
male: 193 g / female: 163 g
Gross pathology:
NECROPSY FINDINGS:
Animals that died:
- heart: acute dilatation
- acute passive hyperemia
- stomach: dilated and liquid contents
- organs/muscles/adipose tissue: colored
- intestines: liquid contents in some animals and atonic
Sacrificed animals:
- organs: no abnormalities detected

Any other information on results incl. tables

MORTALITY DATA:

Male animals:

Dose (test material) (mg/kg)

Dose (act. ingr.) (mg/kg)

Dead animals/animals per group after

1 h

24 h

48 h

7 d

14 d

316

126

0/5

0/5

0/5

0/5

0/5

464

186

0/5

1/5

2/5

3/5

3/5

681

272

0/5

0/5

1/5

4/5

4/5

1000

400

0/5

1/5

5/5

5/5

5/5

  

Female animals:

Dose (test material) (mg/kg)

Dose (act. ingr.) (mg/kg)

Dead animals/animals per group after

1 h

24 h

48 h

7 d

14 d

316

126

0/5

1/5

1/5

2/5

2/5

464

186

0/5

1/5

4/5

4/5

4/5

681

272

0/5

2/5

3/5

4/5

5/5

1000

400

0/5

4/5

5/5

5/5

5/5

Applicant's summary and conclusion