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Description of key information

Acute oral toxicological investigations were conducted in an old study after administration of Macrolex Red 5B to male Wistar rats.

After single administration of 5000 mg/kg no clinical systemic poisoning were observed. No deaths occurred. The male rats sacrificed at the end of the study did not show any noticeable gross pathological findings.

The discriminating dose is >1175 mg/m3 in an OECD TG 403 complient recent acute inhalation study. The mean mass median aerodynamic diameter (MMAD) was 11.18 µm and the mean geometric standard deviation (GSD) was 2.24. Animals exposed to the test item did not reveal any clinical symptoms. Nonetheless test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery. No toxicological relevant test item-related changes in incremental body weight gain were observed. Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups. Mortality did not occur at 1175 mg/m3. No gross pathological findings were found in animals exposed to the test item. In summary, the maximum attainable aerosol concentration was tested in this study.

No acute dermal toxicity study is available. Based on the low oral toxicity and no irritation potential to skin or eyes, no dermal toxicity is anticipated.

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
Acute toxicological investigations were conducted after oral administration of 5000 mg/kg MACROLEX Red 5B to 10 male Wistar rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
physical state: solid
Appearance: red powder
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules (supplier: Firma Bogner, Solingen) at a room temperature of 22 ± 2 •c, with artificial lighting from 6 a.m. to 6 p.m., relative humidity of about 50 ± 10% and approximately ten air changes per hour.
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
The substance was suspended in Lutrol (Polyethylene glykol 400) at room temperature on a magnetic stirrer.
Details on oral exposure:
The substance was suspended in Lutrol (Polyethylene glykol 400) at room temperature on a magnetic stirrer. It was then administered intragastrically to 10 male animals each by way of a rigid metal gavage at a constant application volume of 20 ml/kg body weight. The test substance was formulated in the application medium immediately before administration.
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During
inspections, the type, onset, duration, and intensity of clinical signs were recorded and any dead animals were removed. The time of deat of the deceased was documented.

The animals were weighed before administration (day 0) and at the end of the observation period. The application volume for each individual animal was based on its body weight just before application.
Statistics:
not applied
Sex:
male
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
noe deaths
Clinical signs:
Aftersingle administration of 5000 mg/kg MACROLEX Red 5B no clinical signs were observed.
Body weight:
Growth was not retarded
Gross pathology:
no noticeable gross pathological findings
Other findings:
no data
Interpretation of results:
GHS criteria not met
Executive summary:

Acute toxicological investigations were conducted in an old study after oral administration of Macrolex Red 5B to male Wistar rats.

After single administration of 5000 mg/kg no clinical systemic poisoning were observed. No deaths occurred. The male rats sacrificed at the end of the study did not show any noticeable gross pathological findings.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 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
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
traditional method
Limit test:
yes
Specific details on test material used for the study:
Test item: Macrolex Rot 58
Purity: 99.4 %
Aggregation state: solid powder, red
Batch number: CHC002


Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
A study on the acute inhalation toxicity of Macrolex Rot 58 (henceforward referred to as test item) on rats has been conducted in accordance with OECD Test Guideline no. 403 (2009). Test procedures were adapted so as to comply also with the Method B.2 of the Annex to Regulation (EC) No 440/2008, and especially OECD Guidance Document no. 39 (2009). One group of rats, consisting of 3 male and 3 female animals, was nose-only exposed to the solid aerosol of the test item at the maximum attainable concentration of 1175 mg/m3. Efforts have been made to meet the limit test criteria of the OECD Test Guideline no. 403 (2009). Animals were exposed to 1175 mg/m3 of an aerosol with a mean MMAD of 11.18 µm and mean GSD of 2.24. The generation of a test atmosphere with higher concentrations as well as lower MMAD was from a technical point of view not feasible, also using two other dust
generators. Furthermore micronization was not feasible as well. Thus 1175 mg/m3 was considered to be the highest technically feasible concentration with lowest achievable MMAD. Rats exposed to dry conditioned air only under otherwise identical circumstances served as controls.
Route of administration:
inhalation: mist
Type of inhalation exposure:
nose only
Vehicle:
clean air
Mass median aerodynamic diameter (MMAD):
11.18 µm
Geometric standard deviation (GSD):
2.24
Remark on MMAD/GSD:
The generation of a test atmosphere with higher concentrations as well as lower MMAD was from a technical point of view not feasible, also using two other dust generators. Furthermore micronization was not feasible as well. Thus 1175 mg/m3 was considered to be the highest technically feasible concentration with lowest achievable MMAD.
Details on inhalation exposure:
Three male and three female rats were simultaneously exposed under nose-only conditions for 4 h. This procedure is in compliance with the limit test described in OECD Test Guideline No. 403 and OECD GD#39 (2009).
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1175 mg/m3
No. of animals per sex per dose:
3 males and 3 females
Control animals:
yes
Details on study design:
This procedure is in compliance with the limit test described in OECD Test Guideline No. 403 and OECD GD#39 (2009).
Statistics:
not applicable
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
1 175 mg/m³ air (analytical)
Based on:
act. ingr.
Exp. duration:
4 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no
Clinical signs:
other: Test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery.
Body weight:
No toxicological relevant test item-related changes in incremental body weight gain were observed.
Gross pathology:
No gross pathological findings were found in animals exposed to the test item.
Other findings:
Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups.
Interpretation of results:
GHS criteria not met
Executive summary:

The mean mass median aerodynamic diameter (MMAD) was 11.18 µm and the mean geometric standard deviation (GSD) was 2.24. Animals exposed to the test item did not reveal any clinical symptoms. Nonetheless test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery. No toxicological relevant test item-related changes in incremental body weight gain were observed. Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups. Mortality did not occur at 1175 mg/m3. No gross pathological findings were found in animals exposed to the test item. In summary, the maximum attainable aerosol concentration was tested in this study.

The discriminating dose is >1175 mg/m3

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
1 175 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No acute toxicity was seen in acute oral or inhalation toxicity studies. Classification is not warranted.