Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

most likely 8002-74-2

IUPAC Name:

most likely 8002-74-2

Constituent 2

Reference substance name:

R 9107 paraffin wax

IUPAC Name:

R 9107 paraffin wax

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 or test system 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:

other: No signs of clinical toxicity were observed through the study period in either male or female rats in both dose groups.

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.