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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was classified as reliable without restriction. The study was conducted according to OECD guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): R 9107
- Substance type: Paraffin wax
- Physical state: Solid
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
- Other: White, hard block (wax) in appearance

Test animals

Species:
rat
Strain:
other: SPF Wistar rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Zucht Winkelmann (Paderborn)
- Age at study initiation: Not reported
- Weight at study initiation: 113.8 grams
- Fasting period before study: 16 hours
- Housing: All animals house in a single cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45-55%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light


IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 mg/mL and 100 mg/mL depending on dose administered
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: Not reported
- Purity: Not reported


MAXIMUM DOSE VOLUME APPLIED:
Doses:
1000 mg/kg and 5000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: 20 minutes, 1, 24, 48, 72 hours and 7 days post dosing; Body weight - prior to dosing and on day 7 post-dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Average (mean) body weights prior- to and post-dosing were calculated for each dosing group.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Based on lack of systemic toxicity or mortality observed at this dose level
Mortality:
No mortality was observed in male or female rats in either dose group through the 7 day observation period.
Clinical signs:
No signs of clinical toxicity were observed through the study period in either male or female rats in both dose groups.
Body weight:
Body weight gain was normal for male and female rats in the 1000 mg/kg dose group. Body weight gain of animals in the highest dose tested (5000 mg/kg) was below average but this was attributed to the fact that animals did not eat properly for the first 2 days post dosing.
Gross pathology:
No treatment-related effects were observed in either male or female rats in both dose groups.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the lack of systemic toxicity or mortality observed at the highest dose tested, the acute oral LD50 is >5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study, groups of fasted, SFP Wistar rats (5/sex) were given a single oral dose of R 9107 in arachis oil at doses of 1000 or 5000 mg/kg bw and observed for 7 days. 

 

There were no treatment related clinical signs, necropsy findings or changes in body weight. Based on the lack of systemic toxicity effects and mortality, the oral LD50 was determined to be >5000 mg/kg bw (male and female).

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because the study was conducted according to OECD guideline 401.