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Administrative data

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:
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
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:
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.
5 222 mg/m³
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.