Z-85

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 15 May 2007 and 6 June 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conduct in accoradance with existing guidelines with none or no significant deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: Pale amber coloured solid block

Details on test material:

Description: Pale amber coloured solid block

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats (Charles River (UK) Ltd, Margate, Kent, UK) were randomly allocated to cages and acclimated for a period of at least five days. Following random selection animals were given a unique number and marked with indelible ink. The number was also written on a cage card. Animals were eight to twelve weeks of age at the start of the study and bodyweight variation did not exceed ± 20% of the initial mean bodyweight of any previously dosed animal(s). Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes. Except for an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet) was allowed throughout the study. Diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study. Temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The air exchange rate was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness. Animals were provided environmental enrichment items that were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Based on the results of a sighting test at a dose level of 2000 mg/kg via gavage, an additional four fasted female animals were given a single oral gavage dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. All animals were subjected to gross necropsy at the end of the observation period, consisting of an external examination and opening of the abdominal and thoracic cavities. Any observed macroscopic abnormalities was recorded.

Doses:

2000 mg/kg

No. of animals per sex per dose:

1 animal for the sighting study; 4 animals for the main study.

Control animals:

no

Statistics:

Not applicable

Results and discussion

Preliminary study:

No mortality was observed in the sighting study.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed.

Mortality:

None

Clinical signs:

None

Body weight:

None

Gross pathology:

None

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute oral toxicity.

Executive summary:

Test Guidance

OECD 420 Fixed dose method

Method and materials

The acute toxicity of this substance was evaluated in rats. Following acclimation, a sighting test at a dose level of 2000 mg/kg via gavage was conducted with one animal. Based on the absence of mortality, an additional four fasted female animals were given a single oral gavage dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. 

Results

No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed. The LC50 (oral) > 2000 mg/kg.

Conclusion

Based on the results of this study, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute oral toxicity.