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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines, but not to GLP and not fully reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA 16CFR 1500.3
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): alkaryl magnesium salt derivative (CAS 71786-47-5)

Test animals

Species:
rat
Strain:
Sherman
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
single dose of undiluted test material administered by oral gavage (intragastrically)
MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg bw
Dose volumes: 1, 2, 4, 8 and 16 mL/kg
Doses:
1000, 2000, 4000, 8000 and 16000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weights were recorded on day of dosing and at termination
- Necropsy of survivors performed: yes
Statistics:
Use of statistics not indicated

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Remarks on result:
other: 95% CL not determined
Mortality:
Mortality did not occur in treated animals. No deaths were observed during the 14-day observation period.
Clinical signs:
Animals dosed with 8000 and 16000 mg/kg bw exhibited ruffled fur for 18-24 hours post dosing. They appeared normal within 48 hours.
Body weight:
No significant change in bodyweights occurred in treated animals.
Gross pathology:
No treatment related effects were observed on necropsy.

Any other information on results incl. tables

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

1000

 0/5

-

-

 -

0/5

-

-

2000

 0/5

-

-

 -

0/5

-

-

 4000  0/5  -  -  -  0/5  -  -
 8000  0/5  -  -  - 5/5  -  -
 16000  0/5  -  -  -  5/5  -  -

No deaths were observed during the 14-day observation period. The animals at 8 and 16 g/kg exhibited ruffled fur for 18-24 hours post dosing. Within 48 hours all animals appeared normal. No body weight effects were observed. Gross necropsy findings were unremarkable.

The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of greater than 16.0 g/kg

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mortality did not occur at doses of 16000 mg/kg bw, therefore an LD50 was not determined.
Executive summary:

In an acute oral toxicity study, groups of 5 male Sherman rats were given a single oral dose of alkaryl magnesium salt derivatives at doses of 1000, 2000, 4000, 8000 and 16000 mg/kg bw and observed for 14 days. No mortality occurred, therefore an LD50 has not been determined. Animals dosed with 8000 and 16000 mg/kg bw exhibited ruffled fur for 18-24 hours post dosing but they appeared normal within 48 hours. No significant change in bodyweights occurred in treated animals. No treatment related effects were observed on necropsy. This acute oral toxicity study is acceptable. It satisfies the guideline requirement for an acute oral study in the rat. The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of greater than 16.0 g/kg.