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:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), B.1
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
SAT 080003
Batch No.: Huc-Sa-9370-163
Purity >99% (NMR)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Since the test item was not soluble in water, solubility trials were performed in PEG 300 and corn oil. Both these vehicles were found to be suitable, but corn oil was chosen in order to use the same vehicle as in Harlan Laboratories Study C57885 (acute oral toxicity study with SAT 080004/CAS 1001161-63-2).
This formulation trial is excluded from the statement of compliance.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Per step three females were used. For confirmation of the highest tolerated dose a group of three males was used due to possibility of different responses in both sexes.
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:
All animals survived until the end of the observation period.
Clinical signs:
All three females showed slight sedation, slightly ruffled fur and poor coordination several hours following the treatment. No clinical signs were
observed in any female from day 2 until the end of the observation period.
Slight to moderate sedation, ruffled fur and poor coordination were also noted in the three males several hours after the treatment. In addition, all males showed hunched posture and one of them showed ventral recumbency 5 hours post-dosing. This latter animal also showed several clinical
signs on day 2, including ruffled fur, hunched posture, moderate sedation, ocular opacity, and red secretion from nose. The other two males only
showed slightly ruffled fur on day 2. On day 3, no clinical signs were noted in these animals, whereas ruffled fur and hunched posture were still
observed in the third male. No clinical signs were observed in any male from day 4 until the end of the observation period.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information EU DSD and Regulation (EC) No 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of SAT 080003 after single oral administration to rats of both sexes, observed over a period of 14 days, is:
LD50 (rat): greater than 2000 mg/kg body weight

Based upon the results of this study the following classifications are proposed:

• According to the Commission Directive 2001/59/EC of 06 August 2001 (Official Journal of the European Communities Nr. L 225/1, August 21,
2001), SAT 080003 does not have to be classified and labelled with respect to acute oral toxicity in the rat.

• According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, SAT 080003 does not have to be classified and labelled with respect to acute oral toxicity in the rat.

• According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Second revised Edition, 2007, SAT 080003 should be classified as Category 5.
Executive summary:

Two groups, each of three female or three male RccHan:WIST (SPF) rats, were treated with SAT 080003 by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was formulated in corn oil at a concentration of 0.2 g/mL and administered at a dosing volume 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 once daily during test days 2-15. Mortality/viability was recorded within the first 30 minutes and approximately 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 recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the observation period.

All three females showed slight sedation, slightly ruffled fur and poor coordination several hours following the treatment. No clinical signs were observed in any female from day 2 until the end of the observation period. Slight to moderate sedation, ruffled fur and poor coordination were also noted in the three males several hours after the treatment. In addition, all males showed hunched posture and one of them showed ventral recumbency 5 hours post-dosing. This latter animal also showed several clinical signs on day 2, including ruffled fur, hunched posture, moderate sedation, ocular opacity, and red secretion from nose. The other two males only showed slightly ruffled fur on day 2. On day 3, no clinical signs were noted in these animals, whereas ruffled fur and hunched posture were still observed in the third male. No clinical signs were observed in any male from day 4 until the end of the observation period.

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 SAT 080003 after single oral administration to rats of both sexes, observed over a period of 14 days, is:

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

Based upon the results of this study the following classifications are proposed:

• According to the Commission Directive 2001/59/EC of 06 August 2001 (Official Journal of the European Communities Nr. L 225/1, August 21, 2001), SAT 080003 does not have to be classified and labelled with respect to acute oral toxicity in the rat.

• According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, SAT 080003 does not have to be classified and labelled with respect to acute oral toxicity in the rat.

• According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Second revised Edition, 2007, SAT 080003 should be classified as Category 5.