2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and is described in sufficient detail. Comparable to guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

: 3 instead of 5 animals per dose

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate

EC Number:

258-946-7

EC Name:

2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate

Cas Number:

54060-92-3

Molecular formula:

C20H24N3O.CH3O4S C21H27N3O5S

IUPAC Name:

2‐{[2‐(4‐methoxyphenyl)‐2‐methylhydrazin‐1‐ylidene]methyl}‐1,3,3‐trimethyl‐3H‐indol‐1‐ium methyl sulfate

Details on test material:

- Name of test material (as cited in study report): Basacryl-Goldgelb X-GFL konz.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: 233 g (males), 184 g (females)
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm²
- Cover: inert plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tempered water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (50% concentration), 1000 mg/kg (50% concentration, 400 mg/kg (50% concentration), 200 mg/kg (25% concentration) and 100 mg/kg (25% concentration)

Duration of exposure:

24 hours

Doses:

2000, 1000 and 400 mg/kg bw (test item concentration: 50% in water); 200 and 100 mg/kg bw (test item concentration: 25% in water)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Investigations: Mortality, clinical signs, local effects
- Necropsy performed: yes

Statistics:

N.A.

Results and discussion

Preliminary study:

N.A.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

see table 1 in section "any other information on results incl. tables"

Clinical signs:

other: Systemic clinical signs: dyspnea, apathia, excitation, ataxia, spastic gait and poor general condition

Gross pathology:

Dead animals: heart: acute hyperemia; stomach organs, fat tissue/musculature: substance-related discoloration

Surviving animals: no effects

Other findings:

N.A.

Any other information on results incl. tables

Table 1: Mortality
Dose (mg/kg bw)	Concentration (%)	Animal number	found dead within
			1 hour	24 hours	48 hours	7 days	14 days
2000	50	3m	0/3	0/3	1/3	1/3	1/3
		3f	0/3	2/3	2/3	2/3	2/3
1000	50	3m	0/3	0/3	1/3	0/3	0/3
		3f	0/3	1/3	1/3	1/3	1/3
400	50	3m	0/3	0/3	0/3	0/3	0/3
		3f	0/3	0/3	0/3	0/3	0/3
200	25	3m	0/3	0/3	0/3	0/3	0/3
		3f	0/3	1/3	1/3	1/3	1/3
100	25	3m	0/3	0/3	0/3	0/3	0/3
		3f	0/3	1/3	1/3	1/3	1/3

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 in male and female rats is approx. 2000 mg/kg bw based on a product containing 75% of the test item. The corrected LD50 is approx. 1500 mg/kg.

Executive summary:

In an acute dermal toxicity study Sprague Dawley rats (3 males and 3 females per dose group) were dermally exposed to a product containing 75% of the test item in water for 24 hours to 50 cm² of body surface area at 2000, 1000, 400, 200 and 100 mg/kg bw. Animals were observed for a total of 14 days. The animals showed the following systemic clinical signs: dyspnea, apathia, excitation, ataxia, spastic gait and poor general condition. Two females and one male animal of the high dose group died during the observation period. Furthermore, one female animal of the dose groups 100, 200 and 1000 mg/kg bw was found dead within the 14 days. Gross pathology of animals found dead showed an acute hyperemia of the heart and a substance-related discoloration of the stomach, fat tissue and of the musculature. Animals survived the entire observation period showed no treatment related effects at gross pathology observations. Based on the results obtained, the dermal LD50 value of the product in rats was established to be approx. 2000 mg/kg body weight for both sexes. Based on the test item (75%), the corrected LD50 is approx. 1500 mg/kg.