Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Dose levels are in terms of the test item as supplied by the sponsor.
The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weighed: volume).
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occured during the study.
Clinical signs:
One hour after treatment all female animals showed slightly ruffled fur which persisted up to the 5-hour reading. In the male animals slightly ruffled fur was observed 5 hours after treatment. There were no furthere clinical signs noted until test day 15, the end of observation time.
Body weight:
The body weight of animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macrosopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified EU DSD and UN GHS
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of GRO 266 after single oral administratin to rats of both sexes, observed over a period of 14 days is:
LD50(rat): greather than 2000 mg/kg body weight
This result corresponds to Category 5 or Unclassified based on the GHS classification criteria and an LD50 cut off of 5000 mg/kg body weight according to the OECD 423 Test Procedure.
Executive summary:

Two groups, one of three female and one of three male HanRcc: WIST(SPF) rats, were treated with GRO 266 by oral gavage administration at a dosage of 2000 mg/kg bw. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/ml and administered at avolume of 10 ml/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1,2,3 and 5 hours after treatment on day 1 and ance daily during test days 2 -15. Mortality/viability was recorded at approximately 30 minutes, 1,2,3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 -15. Body weights were on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopally.

All animals survived until the end of the study period.

One hour after treatment all female animals showed slightly ruffled fur which persisted up to the 5-hour reading. In the male animals slightly ruffled fur was observed 5 hour after treatment. There were no further clinical signs noted until test day 15, the end of observation time.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were recorded at necropsy.

The median lethal dose of GRO 266 after single oral administration to rats of both sexes, observed over a period of 14 days is:

LD50(rat): greather than 2000 mg/kg body weight

This result corresponds to Category 5 or Unclassified based on the GHS classification criteria and an LD50 cut off of 5000 mg/kg body weight according to the OECD 423 Test Procedure.