Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex

Endpoint summary

Description of key information

- Acute oral toxicity: In a study (1973) similar to OECD TG 401, non-GLP, the LD50 was determined to be greater than 6000 mg/kg bw in rats. Responses to the administered test substance were negligible. No death occured at any dosage levels used.

- Acute inhalative toxicity: No study was performed with the test item. Reliable experimental data from an analogue substances are available. Based on the absence of mortality in a study (2018) according to OECD TG 403 and GLP, the LC50 was determined to be greater than 5 mg/L in male and female rats.

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif:RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 and 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night before starting the treatment
- Housing: the animals were segregated and housed in Macrolon cages in groups of 5.
- Diet: The animals received water and food ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 50 %

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Concentration used: 30% (w/v)

Doses:

4640, 6000 mg/kg bw (no higher doses were possible)

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered wihtin 5 days.

Body weight:

no data

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.

Executive summary:

Groups of twenty, 6 to 7 weeks old Tif. RAI rats (10/sex) were given a single oral dose of the test substance in carboxymethyl cellulose (CMR) at doses of 4640 and 6000 mg/kg bw (no higher doses were possible) and observed for 7 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 5 days and no death occured at any dosage levels used. The acute oral LD50 of the test substance after a single oral administration to rats is greater than 6000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

6 000 mg/kg bw

Quality of whole database:

Study was conducted similar to OECD TG 401, non-GLP, Klimisch 2.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please, see the attached justification.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: CAS 6417-83-0

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 mg/L

Physical form:

inhalation: aerosol

Quality of whole database:

Study was conducted according to OECD TG 403, GLP, Klimisch 1.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

In an acute oral toxicity study (BASF, 1973), groups of twenty 6 to 7 weeks old Tif. RAI rats (10/sex) were given a single oral dose of the test substance in carboxymethyl cellulose (CMR) at doses of 4640 and 6000 mg/kg bw (no higher doses were possible) and observed for 7 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 5 days and no death occured at any dosage levels used. The acute oral LD50 of the test substance after a single oral administration to rats is greater than 6000 mg/kg bw.

 

Acute inhalative toxicity

A study on acute toxicity via inhalation was not performed for the test item. Reliable experimental data for an analogue approach are available. Please, see the attached read-across justification in section 7.2.2 or 13.

 

CAS 6417-83-0:

An acute inhalation toxicity study was performed according OECD TG 403 and GLP principles with male and female rats. The test concentration was analyzed to be approximately 5 mg/L. During exposure, slow breathing and/or laboured breathing was seen for all animals. Lethargy, hunched posture, laboured respiration were observed in all animals. Animals recovered from the clinical signs at day 4 and 5. No mortality was seen during exposure or during the 14 day observation period. Red staining of the animals was noted throughout the observation period and was considered to be due to the staining properties of the test item and therefore not toxicologically relevant. Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals.

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 1272/2008. No mortality occurred in both tests. As a result, the substance is not considered to be classified for acute oral or inhalative toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.