[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well described, no GLP and no international guideline followed. Read across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Malachite Green Oxalate

IUPAC Name:

Malachite Green Oxalate

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 98 days old
- Number of animals: 9 males, 14 females
- Weight at study initiation: Males 165 -184 g and females 160-182 g
- Diet: pellet Alrtomin R 1324 ad libitum
- Water: Tap water ad libitum
- Other: all animals were marked into skin by picric acid

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5 °C
- Humidity (%): 60 ± 5%
- Photoperiod: 12 H radk/light cycle, artificial light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE: oral, gavage

Doses:

0.5, 0.8, 1.3, 1.6, 2.0 ml/kg/bw

No. of animals per sex per dose:

5 animal x each sex x dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

The calculation of the LD-50 for the confidence interval p <0.05 was conducted in accordance with to Rosier et al.J. Tox. Environ. Health 3, 1977, 797th

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1.2 mL/kg bw

Based on:

test mat.

95% CL:

> 1.1 - < 1.4

Remarks on result:

other: Estimated at 100 %: LD50 = ca 674 mg/Kg bw

Mortality:

All animals are dead by a dose of 5 ml/kg bw. The deaths were within the first 6 days after the application registered.

Clinical signs:

other: Dose levels between 0.8 to 2.0 ml/kg: in all the animals worsening health and bristling. At doses ≥ 1.3 ml/kg:: manifest signs of relaxation and abdominal numbness. At doses ≥ 0.8 ml / kg: growth retardation. The symptoms occurred about 1 to 2 hours afte

Any other information on results incl. tables

Results are expressed as ml/kg; correcting the value following the sample density indicated on the original report (1.123 g/mL) result is LD50 = 674 mg/kg bw

Group	Dose [ml/kg bw]	Result	Symptoms duration	Dead time	Mortality
Males and females
1	0.5	0/0/10	--	--	0
2	0.8	2/10/10	24h - 14d	3d - 6d	20
3	1.3	5/10/10	2h - 7d	4h - 5d	50
4	1.6	7/10/10	1h - 14d	2h - 3d	70
5	2.0	10/10/10	1h - 2d	2h - 3d	100

Applicant's summary and conclusion

Interpretation of results:

other: CLP: Acute tox 4

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Estimated at 100 %: LD50 = ca 674 mg/Kg bw

Executive summary:

Acute oral toxicity test with MS Astrazon Gruen liquid 50% by administration to gavage on male and female wistar rats.

Estimated at 100 %: LD50 = ca 674 mg/Kg bw