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Toxicological information

Acute Toxicity: oral

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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal gavage. 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 dead animals were removed. The time of death of the deceased animals was documented.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Designation: Macrolex Green G
Physical state: solid
Appearance: green powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Experimental Animais
The acute toxicity experiment was carried out with young-adult SPF-bred female Wistar rats (Strain TNO/W70 (SPF Cpb).
The rat is the preferred species for investigating acute oral toxicity in mammals. At the start of the experiment, the rats were about 8 weeks of age.
The average initial weight of the female animals was 130 g. 10 rats were used per dose.

Housing Conditions
The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules at a room temperature of 22 ± 2 °C, with humidity of about 50 ± 10%.

Nutrition
The animals received standard diet and tap water a libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal gavage on a constant application volume of 30 ml/kg body weight.
Doses:
10000 or 15000 mg/kg bw.
No. of animals per sex per dose:
10 female animals/dose.
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 an dead animals were removed. The time of death of the deceased animals was documented. The animals were weighed individually directly before administration and groupwise after one week and at the end of the observation.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
15 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the 14-day observation period.
Clinical signs:
After single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication.
Gross pathology:
Not examined.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 was greater than 15000 mg/kg bw (discriminating dose).
Executive summary:

A single dose of 10000 or 15000 mg/kg bw of the test substance was applied to 10 female Wistar rats each per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. After the single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication. No animals died during the 14-day observation period. The LD50 was greater than 15000 mg/kg bw (discriminating dose).