Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates

Endpoint summary

Description of key information

LD50, rat, oral, (m/f) > 2000 mg/kg OECD 401, limit test

LC0, inhalation, > 6.51 mg/l, OECD 403

LD50, dermal > 2500 mg/kg, OECD 402

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

Study period:

November 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: five to eight weeks old
- Weight at study initiation: 142 - 177 g
- Fasting period before study: overnight
- Housing: in groups of up to five by sex in solidfloor polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 45 - 54%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

Doses:

1

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2, 4h, and each day until day 14
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes

Preliminary study:

Of two tested animals (male and female) at 2000 mg/kg bodyweight no signs of systemic toxicity were noted, the staining of the fur and the faeces were blue-coloured from 4 h up to 3 days.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: Dark blue-coloured liquid discharged from the anus was noted in all animals four hours after dosing. Dark blue-coloured staining of the fur was commonly noted. All animals recovered one day after dosing.

Gross pathology:

no abnormalities

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Qualifier:

according to guideline

Guideline:

other: H.F. Smyth et. aI .: Am. Ind. Hyg. Ass. J. 23, 95-107 (1962)

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the enrichment 200 L air/h were ducted through a 5 cm layer of the test substance. The mean concentration was calculated to be 6.51 mg/L

FORM AS APPLIED IN THE TEST
solid

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 547 - 822 g

ENVIRONMENTAL CONDITIONS
not specified

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

calculated concentration: 6.51 mg/L

No. of animals per sex per dose:

6

Control animals:

not specified

Details on study design:

- Observation period following administration: no
- Frequency of observations: 3, 10, 30 min, 1, 3, 7h
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

6.51 mg/L air

Based on:

test mat.

Exp. duration:

7 h

Mortality:

no mortality

Clinical signs:

other: no abnormalities

Body weight:

not specified

Gross pathology:

no results

Other findings:

Purple staining of the fur by the test substance was observed throughout the study period.

Interpretation of results:

GHS criteria not met

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the enrichment 200 L air/h were ducted through a 5 cm layer of the test substance. The mean concentration was calculated to be 7.53 mg/L

FORM AS APPLIED IN THE TEST
solid

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Mean weight at study initiation: 157 g

ENVIRONMENTAL CONDITIONS
not specified

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

calculated concentration: 7.53 mg/L

No. of animals per sex per dose:

6

Control animals:

yes

Remarks:

air control

Details on study design:

- Observation period following administration: yes, one week
- Frequency of observations: 3, 10, 30 min, 1, 3, 8h
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

7.53 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Mortality:

no mortality

Clinical signs:

other: slight mucosal irritations

Body weight:

not specified

Gross pathology:

no results

Other findings:

Purple staining of the fur by the test substance was observed throughout the study period.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

6.51 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

other: D.N.Noakes & D.M.Sanderson (A Method for Determining the Dermal Toxicity of Pesticides; Brit. Journ. Ind. Med. 26, 59, 1969)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga
- Weight at study initiation: 107 - 152 g
- Housing: not specified

ENVIRONMENTAL CONDITIONS
not specified

Type of coverage:

not specified

Vehicle:

water

Remarks:

aqua dest.

Details on dermal exposure:

TEST SITE
- Area of exposure: back, 50 cm²
- % coverage: not specified
- Type of wrap if used: not specified

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2500 mg/kg
- Concentration: 50 %

Duration of exposure:

24 h

Doses:

2500 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 24, 48 h, 7, 14 days
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: no results

Gross pathology:

no results

Other findings:

Purple remains of the test substance were observed throughout the study period.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Additional information

VIA ORAL ROUTE:

KEY: Acute oral toxicity (Ferro, 1993)

In an acute oral toxicity study performed according to OECD 401, a fixed concentration of 2000 mg/kg bw of Pigment Violet 3 PTM was administered by gavage to five fasted Sprague-Dawley rats each. The following test substance-related clinical observations were recorded, clinical signs occurred within the first 14 days after administration:

2000 mg/kg: No mortality in all animals; good general state in all animals;

Dark blue-coloured liquid discharged from the anus was noted in all animals four hours after dosing. Dark blue-coloured staining of the fur was commonly noted. All animals recovered one day after dosing. All animals showed expected gain in bodyweight during the study except for one male which showed a reduced gain in bodyweight during the second week. No abnormalities in macroscopic pathological findings.

The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

SUPPORTING: Acute oral toxicity (BASF, 1980)

In an acute oral toxicity study (equivalent or simlar to the method described in OECD guideline 401) five male and 5 female Sprague-Dawley rats were exposed per gavage the read-across substance Similar Substance 01 at 2150 and 5000 mg/kg bw. The animals were observed for clinical signs and mortality during a 14-day post-exposure observation period. No mortality occured. Under the conditions of the test the LD50 in male and female rats after oral application was > 5000 mg/kg bw.

SUPPORTING: Acute oral toxicity (BASF, 1975)

In an acute oral toxicity study (equivalent or simlar to the method described in OECD guideline 401) five male and 5 female Sprague-Dawley rats were exposed via to the read-across substance Similar Substance 02 at 3200, 6400 or 10000 mg/kg bw. The animals were observed for clinical signs and mortality during a 14-day post-exposure observation period. No mortality occured in the 3200 mg/kg bw dose group. At 6400 and 10000 mg/kg bw 4 of 10 and 5 of 10 animals died, respectively. Clinical signs comprised dyspnoea, violet discolored skin and faeces, partially diarrhoea, apathy, and slight atonia. During necropsy, acute cardiac dilation with congestive hyperemia, diarrheal intestinal contents, stomach dilation, and slightly stained organs were observed in animlas that died. Under the conditions of this study the LD50 in male and female rats after oral application was determined to be ca. 10000 mg/kg bw.

VIA INHALATION ROUTE: 

WOE: Acute inhalation toxicity (BASF, 1980)

Six male and six female Sprague-Dawley rats were exposed for seven hours to the read-across substance Similar Substance 01 at a calculated saturated concentrations of 6.51 mg/L air. All animals were observed for clinical signs and mortality during the inhalation exposure. Body weights were recorded prior to exposure on test day 1. After 7h all surviving animals were sacrificed and necropsied.

No mortality and no clinical signs of toxicity after exposure to the test item were detected. No abnormalities in macroscopic pathological findings.

Thus, the LC0, inhalation (aerosol), rat was determined to be > 6.51 mg/L air.

WOE: Acute inhalation toxicity (BASF, 1975)

Six male and six female rats (strain not specified) were exposed for eight hours to the read-across substance Similar Substance 02 at a calculated saturated concentrations of 7.53 mg/L air. All animals were observed for clinical signs and mortality during the inhalation exposure. Body weights were recorded prior to exposure on test day 1. After 8h all surviving animals were sacrificed and necropsied.

No mortality and no clinical signs of toxicity after exposure to the test item were detected. No abnormalities in macroscopic pathological findings.

Thus, the LC0, inhalation (aerosol), rat was determined to be > 7.53 mg/L air.

VIA DERMAL ROUTE:

KEY: Acute dermal toxicity (BASF, 1975)

In an acute dermal toxicity study 5 male and 5 female young adult Sprague-Dawley rats were dermally exposed to a single dose of 2500 mg/kg bw of the read-across substance Similar Substance 02 (as suspension in water) to the clipped skin (dorsal) for 24 hours. The application area was 50 cm². The animals were observed for 14 days. The following test substance-related clinical observations were recorded:

No mortality and no clinical signs of toxicity after exposure to the test item were detected. No abnormalities in macroscopic pathological findings. Purple remains of the test substance were observed throughout the study period.

Thus, the LD0, dermal, rat was determined to be > 2500 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

The acute oral LD50 was determined to be greater than 2000 mg/kg bw. As a result the substance is not classified and labelled as acute toxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

The acute inhalation LC50 was determined to be greater than 6.51 mg/L after 8h exposure in saturated air. As no higher concentrations can be measured due to saturation, the substance is not classified and labelled as acute toxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

 

The acute dermal LD50 was determined to be greater than 2500 mg/kg bw. As a result the substance is not classified and labelled as acute toxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.