Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

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:

weight of evidence

Study period:

December, 1982 - February, 1983

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The global experiment is well documented and scientifically acceptable; nevertheless details about the tested substance composition are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not 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

Principles of method if other than guideline:

The test item acute oral toxicity was tested on male and female wistar rats. The substance was administered by oral gavage in dosage of 0.5, 0.8, 1.3, 1.6, 2.0 ml/kg/bw. The duration of observation period following administration was of 14 days, then animals were necropsied.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

EC Number:

241-922-5

EC Name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

Cas Number:

18015-76-4

Molecular formula:

C23H25N2 x C2HO4

IUPAC Name:

4-{[4-(dimethylamino)phenyl](phenyl)methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium hydrogen 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: 22 ± 1.5 °C
- Humidity: 60 ± 5 %
- Photoperiod: 12 hrs dark/light cycle, artificial light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

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.

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:

1.2 mL/kg bw

Based on:

test mat.

95% CL:

1.1 - 1.4

Mortality:

All animals are dead by a dose of 2 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

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: Acute tox 4 (H302), according to the CLP Regulation (EC 1272/2008)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

LD50 (rat): 1200 mg/kg/bw

Executive summary:

The test item acute oral toxicity was tested on male and female wistar rats. The substance was administered by oral gavage in dosage of 0.5, 0.8, 1.3, 1.6, 2.0 ml/kg/bw. The duration of observation period following administration was of 14 days, then animals were necropsied.

All animals are dead by a dose of 2 ml/kg bw; the deaths were within the first 6 days after the application registered. Dose levels between 0.8 to 2.0 ml/kg caused in all the animals worsening health and bristling. At 1.3 ml/kg manifest signs of relaxation and abdominal numbness were recorded. At 0.8 ml/kg growth retardation was observed. The symptoms occurred about 1 to 2 hours after application and kept in individual animals until the end of the experiment. The LD50 was identified to be 1.2 ml/kg bw.

Conclusion

LD50 (rat): 1200 mg/kg/bw