Reaction mass of melamine and Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes

Endpoint summary

Description of key information

Valid studies for acute oral toxicity according OECD 401 and acute inhalation toxicity according OECD 403 are 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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and well documented

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Five male and five female Wistar rats (158-182 g) received a single dose of 5000 mg/kg bw of Bayplast Gelb 5G per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals sacrificed at the end of the 14 days observation period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

No signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced.

None of the animals sacrificed at the end of study showed any noticable gross pathological findings.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

Five male and five female Wistar rats (158-182 g) received a single dose of 5000 mg/kg bw of Bayplast Gelb 5G per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals sacrificed at the end of the 14 days observation period.

No signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced. None of the animals sacrificed at the end of study showed any noticable gross pathological findings.

LD50 > 5000 mg/kg bw (rat, male + female)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The materials/methods and results are described in detail und are sufficient for evaluation

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

One group of 3 male and 3 female Wistar rats was nose-only exposed to the dry powder aerosol of Gelbpigment E4GN atat an actual concentration of 5222 mg/m³ for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0, 5222 mg/m³

No. of animals per sex per dose:

control group: 5 male and 5 female ratstest group: 3 male and 3 female rats

Control animals:

yes

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

5 222 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m³.

Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.

The respirability of the aerosol was adequate to achieve the objective of study, i.e. the average mass median aerodynamic diameter (MMAD) was 2.8 µm, the average geometric standard deviation (GSD) was 2.7.

Executive summary:

A study on the acute inhalation toxicity of Gelbpigment E4GN on rats has been conducted in accordance with OECD TG#403 (2009). Test procedures were adapted so as to comply also with the EU Directive 92/69/EEC, and especially OECD GD#39 (2009). One group of 3 male and 3 female Wistar rats was nose-only exposed to the dry powder aerosol of Gelbpigment E4GN atat an actual concentration of 5222 mg/m³ for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed. The aerosol was generated so that it was respirable to rats. The results can be summarized as follows:

LC50(inhalation, 4h) -males&females: > 5222 mg/m³

Mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m3. Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.

In summary, the aerosolized test substance (solid aerosol) proved to have essentially no acute inhalation toxicity in rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 222 mg/m³ air

Quality of whole database:

The materials/methods and results are described in detail und are sufficient for evaluation

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the acute oral toxicity study no signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced. None of the animals sacrificed at the end of study showed any noticable gross pathological findings.

In the acute inhalation toxicity study mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m³.

Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.

Justification for selection of acute toxicity – oral endpoint
only available study

Justification for selection of acute toxicity – inhalation endpoint
only available study

Justification for classification or non-classification

Due to the results of the acute oral toxicity study (LD50 > 5000 mg/kg bw) and the acute inhalation toxicity study (LC50 > 5222 mg/m³) a classification is not justified.