Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From June 7,2012 to June 29,2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material: SSP-SAMPLE 1
- Physical state: Amber-yellowish/brown undefined liquid
- Analytical purity:no data
- Substance type: organic viscous paste
- Storage condition of test material: Room temperature
- Water content: 15%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy
- Age at study initiation:6-7 weeks old
- Weight at study initiation: 150 to 174 g
- Fasting period before study: overnight fast prior to dosing and a period of approximately 4 hours after dosing.
- Housing: 5 of one sex to a cage, in polisulphone solid bottomed cages measuring 59 x 38.5 x 20 cm.
- Diet: A commercially available laboratory rodent diet (4RF18, Mucedola S.r.l) will be offered ad libitum throughout the study.
- Water : Drinking water will be supplied ad libitum to each cage via water bottles
- Acclimation period: 5 days
- Health check: yes
- Water content: 15%

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr):15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 ml/kg w

Doses:
5, 50, 300, 2000 mg/kg bw (based on active ingredient)
No. of animals per sex per dose:
4 females x doses
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily
- Sings: Animals will be examined for signs of reaction to treatment on dosing, approximately 30 minutes, 2 and 4 hours after dosing on Day 1, then at least once daily for a total of 14 days.
- Body weight: Each animal will be weighed on the day of allocation to study, on the day of dosing (Day 1) and on Days 2, 8 and 15. Animals dying dur ing the study will be weighed at the time of death or when found.
- Necropsy of survivors performed: yes, Necropsy was carried out on all animals, (gross necropsy examination for both external and internal abnor malities, with particular attention to the gastro-intestinal tract). All abnormalities were recorded.
Animals in extremis and those that have completed the scheduled test period will be killed with carbon dioxide.
- Other examinations performed: gross examination including the opening of the cranial, thoracic and abdominal cavities and the examination of the major organs. The stomach and representative sections of the gastro-intestinal tract will be opened for examination.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
Four additional female animals were treated at 2000 mg/kg. No mortality was observed in the main study. No clinical signs were noted during the observation period in 3 out of 4 animals treated. In the fourth animal (no. 91080023) clinical signs such as salivation, hunched posture, piloerection, rales, breathing difficulties and emaciated appearance were observed generally during the observation period. Due to the nature and succession of these signs, they could be related to a slight damage on dosing.
Body weight:
The body weight changes were within the expected range for this species and age of animals during the study with the exception of the animal showing clinical signs in which a body weight loss was observed.
Gross pathology:
No abnormalities were observed at the necropsy examination performed on termination of the observation period in the sighting study animal and in 3 out of 4 animals of the main study (those who did not show clinical signs). In the remaining animal of the main study, swollen abdomen was noted and at the internal examination, gas content and swelling were observed in the stomach, duodenum, jejunum, ileum, caecum and colon.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results indicate that the test item, has no toxic effect on the rat following oral administration of single doses of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
Executive summary:

The acute toxicity of Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified was investigated following a single oral administration (10 mL/kg in corn oil) to the Sprague Dawley rat followed by a 14-day observation period. A sighting study was performed in which a single female animal was dosed at 2000 mg/kg. No mortality and no clinical signs were seen during the observation period. A main study was then performed on an additional 4 females which were dosed at 2000 mg/kg. No mortality occurred. No clinical signs considered related to the toxicity of the test item were noted during the observation period. The body weight changes observed in the animals were not remarkable with the exception of body weight loss observed in a single animal showing signs that could be unrelated to the toxicity of the test item. All animals were killed at the end of the observation period and subjected to necropsy examination. No abnormalities were observed at the necropsy examination performed on termination of the observation period in 4 out of 5 animals treated. In the remaining animal, swollen abdomen, gas content and swelling were observed in the gastrointestinal tract. These results indicate that the test item,

Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified, has no toxic effect on the rat following oral administration of single doses of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.