[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2011-12-06 to 2011-12-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate

EC Number:

265-449-9

EC Name:

[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate

Cas Number:

65113-55-5

Molecular formula:

C25H30N3.C18H14N3O3S

IUPAC Name:

[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - FRANCE)
- Age at study initiation: MALE: 8 weeks old. FEMALE: 9 weeks old
- Weight at study initiation: MALE : from 265 g to 290 g. FEMALE: from 210 g to 242 g
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5, in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): ad libitum (foodstuff: M20-SDS)
- Water (e.g. ad libitum): ad libitum (tap water from public distribution system)
- Acclimation period: of at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 dark/12 light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

paraffin oil

Details on dermal exposure:

TEST SITE
- Area of exposure:dorsal area of the trunk
- % coverage: at least 10% of the body surface cleared for the application of the test item
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with liquid paraffin
- Time after start of exposure: After 24 hours exposure period

TEST MATERIAL
- Concentration (if solution): 2000 mg/L
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICULE

Duration of exposure:

Exposure period of 24 hours

Doses:

Group 1: 2000 mg/kg
Group 2: 2000 mg/kg

No. of animals per sex per dose:

Group 1: 5 male rats
Group 2: 5 female rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily examination (spontaneous activity, preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance). Weighing on days D0 (before administration of th test item), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examinations at the end of the study (after anaesthesia) with the examination of organs likely to be modified in cases of acute toxicity (oesophagus, stomach, the entire digestiv tract, spleen, liver, thymus, trachea, lungs, heart, kidneyx, urinary bladder, testicules, skin of the treatment area, adrenals, pancreas).

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study

Clinical signs:

other: No clinical sign was observed. A slight black coloration of the treatment site was noted in all animals on D1.

Gross pathology:

No gross pathology was observed.

Any other information on results incl. tables

Current control study: The study identified TAD-PH-11/0623 was performed to assess the behaviour of the strain of rat used at this laboratory in its environment and to give additional historical data. The study was performed from 25 October 2011 to 08 November 2011.

the method was designed to meet the requirements of the following: OECED guideline for the testing of chemicals N°402 dated February 24thn, 1987 and the method B3 of the Council regulation N°440/2008.

Test item: Liquid paraffin

METHODS:

Ten aminals, five males and five females, received by topical administration, an effective dose of 10 ml/kg body weight of the control item liquid paraffin, under porous gauze dressing, during 24 hours.

RESULTS:

Clinical examinations: Nothing to report. Animal normal (10/10)

Bodyweight evolution: Normal throught the study

Necropsy: No treatment related changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.

Executive summary:

The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3. of the Council regulation n°440/2008 of 30 May 2008.

 

No mortality occured during the study.

 

No systemic clinical sign related to the administration of the test item was observed. A slight black coloration of the treatment site was noted in all animals on day 1.

 

The body weight evolution of the animals remained normal throughout the study.

 

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

 

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.

According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item must not be classified. No symbol or risk phrase is required.

In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.