Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: red powder
Details on test material:
no further data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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

Administration / exposure

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

Results and discussion

Effect levels
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:
no clinical signs were observed
Body weight:
growth was not retarded
Gross pathology:
no gross pathological findings

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.