Ferrate(1-), bis[4-[2-[5-chloro-2-(hydroxy-.kappa.O)phenyl]diazenyl-.kappa.N1]-3-(hydroxy-.kappa.O)-N-phenyl-2-naphthalenecarboxamidato(2-)]-, ammonium (1:1)

Endpoint summary

Description of key information

Acute toxicity (oral): LD50 (male/female) > 5000 mg/kg bw (OECD 401)

Acute toxicity (dermal): LD50 (male/female) >2000 mg/kg bw (Annex V; Method B3)

Acute inhalation toxicity LC50 (male/female): >3.37 mg/L air (GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

other: SNIF

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Information from migrated NONS file, as per inquiry number 06-0000021057-76-0000, permission to refer granted by ECHA.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CD rats [Crl : CD(SD)BR]

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: 1 % aqueous methylcellulose

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: No signs of toxicity were observed other than pilo-erection throughout day 1 and day 2. There were no other clinical signs and recovery was complete by Day 3.

Gross pathology:

No effects were observed in any organs.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats, the LD50 (male/female) was >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity test (OECD 401), 5 male and female CD rats [Crl : CD(SD)BR] were adminstered DL-N33 in 1 % aqueous methylcellulose by oral gavage at a dose of 5000 mg/kg bw.

LD50(male/female): >5000 mg/kg bw

There were no deaths. No signs of toxicity were observed other than pilo-erection throughout day 1 and day 2. There were no other clinical signs and recovery was complete by Day 3. No effects were observed in any organs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

There is one study available and the Klimisch code is 2.

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:

other: See 'Remark'

Remarks:

All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

other: 92/69/EEC

Principles of method if other than guideline:

Information from migrated NONS file, as per inquiry number 06-0000021057-76-0000, permission to refer granted by ECHA.

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Type of inhalation exposure:

whole body

Vehicle:

other: none

Duration of exposure:

4 h

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 3.37 mg/L air

Exp. duration:

4 h

Mortality:

Male: 0 mg/L; Number of animals: 5; Number of deaths: 0
Male: 3.37 mg/L; Number of animals: 5; Number of deaths: 0
Female: 0 mg/L; Number of animals: 5; Number of deaths: 0
Female: 3.37 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Signs of exposure were confined to staining of the skin, fur and tail by the substance. There was a small reduction in food and water consumption in male exposed rats on day 1.

Gross pathology:

Effects on organs:
The lungs of all treated animals were coloured greyish due to the substance. Lung to bodyweight ratios were unaffected. No treatment - related changes were found in tissues examined microscopically(lungs, liver, kidneys).

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

3 370 mg/m³ air

Quality of whole database:

There is one study available and the Klimisch code is 2.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

other: SNIF

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Principles of method if other than guideline:

Information from migrated NONS file, as per inquiry number 06-0000021057-76-0000, permission to refer granted by ECHA.

GLP compliance:

not specified

Species:

rat

Strain:

other: CD rats [Crl : CD(SD)BR]

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

other: distilled water

Doses:

2000 mg/kg only (53.3% paste in distilled water)

No. of animals per sex per dose:

5 males
5 females

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: There were no systemic signs of toxicity.

Gross pathology:

Terminal autopsy findings were normal.

Other findings:

Dense black staining prevented assessment of any erythematous responses after removal of the occlusive dressing on Day 2. The slight black staining that persisted on Days 3 and 4 was insufficient
to impede assessment of erythema. No erythema, oedema or other indication of dermal irritation were observed at any site of application during this study.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study in rats, the LD50 (male/female) was >2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study (Annex V; Method B3), 5 male and female CD rats [Crl : CD(SD)BR] were dermally exposed (occlusive) to DL-N33 (53.3% paste) at a dose of 2000 mg/kg bw for 24 hours.

The LD50 (male/female) was >2000 mg/kg bw.

There were no deaths. There were no systemic signs of toxicity. Slightly low bodyweight gains were recorded for one male and one female rat during week 2. Dense black staining prevented assessment of any erythematous responses after removal of the occlusive dressing on Day 2. The slight black staining that persisted on Days 3 and 4 was insufficient to impede assessment of erythema. No erythema, oedema or other indication of dermal irritation were observed at any site of application during this study. Terminal autopsy findings were normal.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

There is one study available and the Klimisch code is 2.

Additional information

Acute oral toxicity

There is one acute oral toxicity study in rats.

In an acute oral toxicity test (OECD 401), 5 male and female CD rats [Crl : CD(SD)BR] were adminstered DL-N33 in 1 % aqueous methylcellulose by oral gavage at a dose of 5000 mg/kg bw. There were no deaths. No signs of toxicity were observed other than pilo-erection throughout day 1 and day 2. There were no other clinical signs and recovery was complete by Day 3. No effects were observed in any organs. The LD50 (male/female) was >5000 mg/kg bw.

Acute dermal toxicity

There is one acute dermal toxicity study in rats.

In an acute dermal toxicity study (Annex V; Method B3), 5 male and female CD rats [Crl : CD(SD)BR] were dermally exposed (occlusive) to DL-N33 (53.3% paste) at a dose of 2000 mg/kg bw for 24 hours. There were no deaths. There were no systemic signs of toxicity. Slightly low bodyweight gains were recorded for one male and one female rat during week 2. Dense black staining prevented assessment of any erythematous responses after removal of the occlusive dressing on Day 2. The slight black staining that persisted on Days 3 and 4 was insufficient to impede assessment of erythema. No erythema, oedema or other indication of dermal irritation were observed at any site of application during this study. Terminal autopsy findings were normal. The LD50 (male/female) was >2000 mg/kg bw.

Inhalation route

There is one inhalation toxicity study in rats.

In an acute inhalation toxicity study (GLP), groups of Sprague-Dawley rats (5/sex) were given DL-N33 (whole body) at a dose of 3.37mg/L air (limit test; maximum attainable concentration) for 4 hours. There were no mortalities in males or females. Signs of exposure were confined to staining of the skin, fur and tail by the substance. There was a small reduction in food and water consumption in male exposed rats on day 1. The lungs of all treated animals were coloured greyish due to the substance. Lung to bodyweight ratios were unaffected. No treatment-related changes were found in tissues examined microscopically (lungs, liver, kidneys). The LC50 (male/female) was >3.37mg/L air.

The studies are suitable to use in the human health risk assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance DL-N33 (CAS No. 104815-18-1) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.