Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

Endpoint summary

Description of key information

Acute Oral toxicity

Rat: LD50 (m/f) > 2200 mg/kg bw (EU B.1; BASF AG, 1993)

Rat:LD50 (m/f) > 5000 mg/kg bw (OECD 401; BASF AG, 1984)

            

Acute Inhalation toxicity

Rat:LC50 (m/f) > 5200 mg/m3, 4h (OECD 403; BASF AG, 1988)

Acute Dermal toxicity

Actually, there is no information available.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

Department of Toxicology, BASF AG

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. Thomae GmbH, D-7950 Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: mean 181 g (males), 174 g (females)
- Fasting period before study: at least 16h, with water ad libitum
- Housing: single housing in stainless steel wire mesh cages, Type DLK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Concentration of test material in vehicle: 11%
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: aquous formulation corrresponds to the physiological medium


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

2200 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 day
- Frequency of observations and weighing: recording of signs and symptomps several times on the day of administration, at least once each workday; individually body weights shortly before application (day 0), and on days 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: In the male and female animals was black discolored feces. Males additionally exhibited piloerection and black smeared fur in the anogenital area

Gross pathology:

No pathological findings

Other findings:

Symptoms after administration of 2200 mg/kg bw of test material in vehicle by gavage:

Males:
day1-day2: piloerection (2/3 animals)
hour4-day2: discoloured feces (black) (3/3 animals)
hour4-day3: black smeared fur in the anogenital area (2/3 animals)

Females:
hour1-day1: discoloured feces (black) (3/3 animals)

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for acute oral toxicity following OECD 401. The test substance showed LD50 (rat, oral) > 2200 mg/kg bw, without mortality or gross pathological changes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 200 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Internal BASF method was used, which were in large parts equivalent to method described in OECD guideline 403

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr . K . Thomas GmbH, 7950 Biberach
- Age at study initiation: 8 weeks
- Weight at study initiation: mean 245 g (males), 161 g (females)
- Housing: five per cage in stainless stelle wire mesh cages, Type D-III
- Diet (e.g. ad libitum): KLIBA Labordiät Ratte/Maus A 343 10 mm Pellet, Klingentalmühle AG, CH-4303 Kaiseraugst; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: INA 20 head/nose inhalation system ( glass/steel construction, BASF AG);
- Exposure chamber volume: ca. 55 l
- Method of holding animals in test chamber: the animals sit in tubes and their snouts project into the inhalation chamber
- Source and rate of air: 1500 l/h of compressed air through the injector and 1500 l/h of conditioned air as dilution air
- Method of conditioning air: via a central airconditioning unit
- System of generating particulates/aerosols: the substance to be tested was transformed into a dust aerosol by means of a automatic vibrator, and was passed into the inhalation system
- Method of particle size determination: gravimetrically
- Temperature, humidity, pressure in air chamber: 19 - 25°C, 10% lower than that of the supply air system (excess pressure)

TEST ATMOSPHERE
- Brief description of analytical method used: The preweighed filter was placed in a filtration equipment. A volume of dust aerosol characterized by a flow-limiting nozzle was passed through the filter by means of a vacuum compressed air pump. The dust concentration (mg/l) was calculated from the difference between the preweight of the filter and the weight of the filter after sampling with reference to the sample volume.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: dust proportion of 83% .
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.2 µm / 2.8

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically

Duration of exposure:

4 h

Concentrations:

5.2 mg/l

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were checked before the start of the study, after 7 days and at the end of the observation period. The animals were checked for clinical signs on each working day. The lethality was checked daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The statistical evaluation of the concentration response relationship was based on the binomial test (Wittig, H.: Mathematische Statistik 1974, (Mathematical Statistics), pages 32 to 35) according to the Tables issued by the BASF computer center.
The particle size determination was based on mathematical and graphical evaluation methods for particle measurements (Silverman, L .: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235 - 259) and was carried out at the Department of Toxicology of BASF AG.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air (analytical)

Exp. duration:

4 h

Remarks on result:

other: dust

Mortality:

No mortality

Clinical signs:

other: During exposure: initially attempts to escape, irregular breathing After exposure: nothing abnormal detected

Body weight:

Mean body weights (g) on days 0/7/14:
- Males: 245 / 275 / 308
- Females: 161 / 177 / 189

Gross pathology:

Nothing abnormal detected in the organs

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for acute toxicity inhalation following internal guidelines similar to OECD 403. This dust inhalation study shows that the LC50 (rat,inhalation) is >5.2 mg/l. No mortality or gross pathological changes were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 200 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are valid, guideline conform, in vivo data available for the assessment of the acute toxicity of the test substance.

Acute Oral toxicity

The acute oral toxicity of the test substance was investigated in two groups of 3 male and 3 female rats according to EU B.1/OECD 401 guideline, given a limit dose of 2200 mg/kg bw as gavage. Clinical signs were discoloured feces for male and female rats and piloerection and smeared fur in the anogenital area in male animals. No mortality or gross pathological changes were reported.

In the second study the acute oral toxicity of the test substance was investigated according to OECD guideline 401 in two groups of 3 male and 3 female rats, given a limit dose of 5000 mg/kg bw as gavage. Clinical signs were black feces for male and female rats. No mortality or gross pathological changes were reported.

 

Acute Inhalation toxicity

The acute dust inhalation toxicity of the test substance was investigated according to OECD 403 guideline in 5 male and 5 female rats. The test material was applied as dust (dust generator; dose determination: gravimetrically) via head/nose inhalation at a limit dose level of 5200 mg/m3 for 4 hours. Clinical signs during exposure were attempts to escape and irregular breathing. After exposure no deaths and no signs of toxicity were noted.

 

Acute Dermal toxicity

Appropriate data to assess the acute dermal toxicity of the test article are not available.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be ore than 2200 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.

For Acute toxicity inhalation route (dusts and mists, mg/l)

Category 1: ATE <= 0.05

Category 2: 0.05 < ATE <= 0.5

Category 3: 0.5 < ATE <= 1

Category 4: 1 < ATE <= 5

The LC50 of the test substance was determined to be more than 5.2 mg/l, therefore, the test substance is not classified for Acute toxicity by inhalation exposure.