Registration Dossier

Administrative data

Description of key information

LD50 rat (oral): ca. 234 mg/kg bw
LC50 rat (by inhalation; inhalation hazard test): > 4.32 mg/l air

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
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
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

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

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
234 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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
Principles of method if other than guideline:
Based on H.F. Smyth et al. (1962), Am. lnd. Hyg. Ass. J. 23, 95-107.
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20 °C. Young adult laboratory rats, 3 per sex, were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h.
GLP compliance:
no
Test type:
other: Inhalation hazard test
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 227 g (mean)/ female: 180 g (mean)



Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature in air chamber: 20 °C


Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
7.56 mg/l, corresponding to ca. 3.02 mg/l EVA
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7.56 mg/L air
Based on:
other: preparation containing ca. 40% ethylviolet acetate, ca. 17% acetic acid, ca. 17% confidential component and ca. 26% water
Exp. duration:
8 h
Remarks on result:
other: no mortality
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.32 mg/L air
Based on:
other: registered substance
Exp. duration:
8 h
Remarks on result:
other: no mortality
Mortality:
No mortality was observed.
Clinical signs:
No symptoms were observed.
Body weight:
male: 227 g / female: 180 g
Gross pathology:
During necropsy nothing abnormal was detected.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

In the key study that was performed equivalent or similar to the methods described in OECD Guideline 401 five rats per sex and dose were treated simultaneously by gavage with a preparation of the test substance (ca. 40% ethylviolet acetate, ca. 17% acetic acid, ca. 17% confidential component and ca. 26% water) in water at doses of 316, 464, 681, 1000 mg/kg bw. Group-wise documentation of clinical signs was performed over the 14-day study period. Clinical signs were poor general state with staggering in some animals, atony, pareses, narcotic-like state with absence of pain reflex, tremors, spastic gait, diarrhea and salivation, and occasionally substantial loss of weight at the beginning. Necropsy findings in animals that died were acute dilatation and acute passive hyperemia of the heart, dilation and liquid contents of the stomach, colored organs/muscles/adipose tissue, and liquid intestinal contents in some animals and atonic intestines. In sacrificed animals no abnormalities were detected in organs at necropsy. The LD50 was determined to be approx. 410 mg/kg bw (BASF AG, 1978).

The substance registered in this dossier consists of 70% ethylviolet acetate, 25% acetic acid and some minor impurities not contributing to the classification. Acetic acid is classified as a dangerous substance, but not for acute oral toxicity. The presence of 25% acetic acid is therefore not considered of toxicological relevance for this endpoint. Because the concentration of ethylviolet acetate in the substance which is registered is 70%, it is believed that the actual oral LD50 is approximately 234 mg/kg bw.

Inhalation:

The key study is a study on the acute inhalation hazard of ethyl violet liquid (ca. 40% ethylviolet acetate, ca. 17% acetic acid, ca. 17% confidential component and ca. 26% water) in rats (inhalation hazard test based on H. F. Smyth et al. (1962), Am. Ind. Hyg. Ass. J. 23, 95-107). Twelve young adult laboratory rats were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The mean concentration was 7.56 mg/l. No symptoms were observed. During necropsy nothing abnormal was detected. No mortality was observed (BASF AG, 1978).

The substance registered in this dossier consists of 70% ethylviolet acetate, 25% acetic acid and some minor impurities not contributing to the classification. Acetic acid is classified as a dangerous substance, but not for acute inhalation toxicity. The presence of 25% acetic acid is therefore not considered of toxicological relevance for this endpoint. Because the concentration of ethylviolet acetate in the substance which is registered is 70%, it is believed that the actual LC50 is higher than 4.32 mg/l.

Dermal:

There are no data available concerning the acute dermal toxicity of the substance.

Justification for classification or non-classification

As no mortality was observed in the acute inhalation toxicity study (LC50 > 4.32 mg/l), classification for acute inhalation toxicity is not needed.

Based on the results of the acute oral toxicity study with rats (oral LD50 = ca. 234 mg/kg bw), the substance has to classified as follows: Xn, R22 according to Directive 67/548/EEC and H301, Category 3 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.