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Description of key information

A valid acute oral study equivalent to OECD 401 (limit test) and an inhalation toxicity study according OECD 403 are available. No acute dermal study is on hand.

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: short report, in compliance with the guideline
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 were given 5000 mg MACROLEX Red CA 51038 (CAS no 6829-22-7)/kg bw dissolved in lutrol and observed for mortality and clinical signs and body weight development over a period of 14 days. Gross pathological examinations were done on all animals sacrificed at the end of study.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: males 9 weeks; females 14 weeks
- Weight at study initiation: males ca 158 g; females ca 164 g
- Fasting period before study: 16 hours
- Housing: in groups of 5 per sex
- Diet : fasting post administration for 4 hours then ad libitum
- Water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
Single oral application by gavage of 5000 mg/kg bw to male and female rats
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration and then twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological evaluation
Statistics:
no
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit test: no animal died, no clinical signs, growth not retarded
Mortality:
no rat died
Clinical signs:
other: no clinical signs were observed
Gross pathology:
no gross pathological findings

After single administration of 5000 mg/kg no clinical signs of systemic poisoning were observed.

No deaths occurred.

The male and female rats sacrificed at the end of the study did not show any noticeable gross pathological findings.

Interpretation of results:
GHS criteria not met
Conclusions:
No animal died. Thus the LD50 is greater than 5000 mg/kg bw/day.
Executive summary:

In a study according to the respective guideline 5 male and 5 female Wistar rats were given 5000 mg MACROLEX Red CA 51038 (CAS no 6829-22-7)/kg bw dissolved in lutrol and observed for mortality and clinical signs and body weight development over a period of 14 days. No animal died or displayed clinical signs. Necropsy revealed no gross pathological changes. Thus the LD50 is considered to be greater than 5000 mg/kg bw/day.

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
A study on the acute inhalation toxicity of Macrolex Rot E2G (CAS no 6829-22-7) on rats has been conducted in accordance with OECD TG#403 (2009). One group of rats was nose-only exposed to the solid aerosol of the test item at the actual concentration of 1817 mg/m³ (maximum attainable concentration). Rats exposed to air only under otherwise identical circumstances served as control animals.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
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:
Actual concentration of 1817 mg/m³
No. of animals per sex per dose:
Three male and three female rats per concentration were simultaneously exposed under nose-only conditions for 4 h.
Control animals:
yes
Key result
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
1 817 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³.
Mortality:
Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³.
Clinical signs:
other: Rats exposed to the test item showed clinical signs (labored breathing, irregular breathing, piloerection).
Body weight:
Significant changes in incremental body weight gain were found in females on day 1.
Gross pathology:
Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³. Rats exposed to the test item showed clinical signs (labored breathing, irregular breathing, piloerection). Significant changes in incremental body weight gain were found in females on day 1. Neither reduction in body temperature nor changes during the reflex measurement were observed. Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality occurs at the technically maximum attainable concentration of 1817 mg/m³.
Executive summary:

A study on the acute inhalation toxicity of Macrolex Rot E2G (CAS no 6829-22-7) on rats has been conducted in accordance with OECD TG#403 (2009). One group of rats was nose-only exposed to the solid aerosol of the test item at the actual concentration of 1817 mg/m³ (maximum attainable concentration). Rats exposed to air only under otherwise identical circumstances served as control animals.

Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³. Rats exposed to the test item showed clinical signs (labored breathing, irregular breathing, piloerection). Significant changes in incremental body weight gain were found in females on day 1. Neither reduction in body temperature nor changes during the reflex measurement were observed. Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

In summary, there is evidence of low acute inhalation toxicity in rats after exposure (4h) of aerosolized Macrolex Rot E2G (CAS no. 6829-22-7). The LC50 is > 1817 mg/m³.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating conc.
Value:
1 817 mg/m³ air
Quality of whole database:
GLP guideline study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the acute oral toxicity study groups of 5 male and 5 female rats were administered by gavage a single oral dose of 5000 mg/kg bw of the test material Macrolex Rot E2G (CAS no. 6829-22-7). Animals were observed for mortality, clinical signs and body weight for 14 days. A gross pathological examination was done on all animals sacrificed at the end of study. No clinical signs of systemic poisoning were observed and no deaths occurred. The male and female rats sacrificed at the end of the study did not show any noticeable gross pathological findings. The LC50 is > 5000 mg/kg bw.

In the acute inhalation toxicity study one group of 3 male and 3 female rats was nose-only exposed to the solid aerosol of the test material at the actual concentration of 1817 mg/m³ (maximum attainable concentration). Rats exposed to air only under otherwise identical circumstances served as control animals.

Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³. Rats exposed to the test material showed clinical signs (labored breathing, irregular breathing, piloerection). Significant changes in incremental body weight gain were found in females on day 1. Neither reduction in body temperature nor changes during the reflex measurement were observed. Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

In summary, there is evidence of low acute inhalation toxicity in rats after exposure (4h) of aerosolized Macrolex Rot E2G (CAS no. 6829-22-7). The LC50 is > 1817 mg/m³.

Justification for classification or non-classification

In the acute oral toxicity study a LD50 > 5000 mg/kg bw and in the acute inhalation toxicity study a LD50 > 1817 mg/m³ (technically maximum attainable concentration) was found.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.