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Administrative data

Description of key information

LD50 oral rat > 2000 mg/Kg bw
LD50 dermal rat > 2000 mg/Kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 7,2012 to June 29,2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guideline
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
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

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.
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.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, 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, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1 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, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Just one good study is available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 16,2012 to June 20,2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guidelines
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Protocol deviations with no negative impact on the study.
Deviations:
yes
Remarks:
Protocol deviations with no negative impact on the study.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Protocol deviations with no negative impact on the study.
Deviations:
yes
Remarks:
Protocol deviations with no negative impact on the study.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan Italy
- Age at study initiation:6-8 weeks old
- Weight at study initiation: 176 to 200 g
- Fasting period before study:
- Housing: limited access rodent facility, individually housed in polisulphone solid bottomed cages measuring 59 x 38.5 x 20 cm. Nesting material wil l be provided inside suitable bedding bags; nesting material will be changed at least twice a week.
- Diet: A commercially available laboratory rodent diet (4RF18 Mucedola ) 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

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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:5 x 7 cm
- % coverage:10%
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in p lace by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.

REMOVAL OF TEST SUBSTANCE
- Washing: The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure:

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw based on active ingredient
No. of animals per sex per dose:
5 x sex x dose
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Signs: Day of dosing (on dosing, approximately 1, 2 and 4 hours after dosing), Daily thereafter (14 days).
- Bodyweight: Allocation (Day -1), Days 1, 8 and 15.
- Necropsy of survivors performed: yes
Animals in extremis and those that have completed the scheduled test period will be killed with carbon dioxide.
- Other examinations performed: All animals will be subjected to gross examination including the opening of the cranial, thoracic and abdominal cavi ties and the examination of the major organs. Particular attention will be paid to the treatment site. All abnormalities will be recorded.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in male or female animals following treatment.
Clinical signs:
Clinical signs recorded during the observation period were limited to the treatment site, in which redness (from marked to slight) and/or scabs were generally observed during the study. Fissuring and desquamation of the treated site were also observed in the females. However, all males recovered from these signs by Day 13 while all females by Day 15.


Body weight:
The body weight changes were within the expected range for this species and age of animals at the end of the study.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, has no systemic toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
Executive summary:

The acute toxicity of PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1 was investigated following dermal administration of a single dose to the rat. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days all animals were killed and subjected to necropsy examination.

No mortality occurred in male or female animals after treatment during the observation period. Clinical signs observed were limited to the treatment site in which redness and/or scabs and/or desquamation and/or fissuring were generally observed during the study. However, all males recovered from these signs by Day 13 while all females by Day 15. The reaction in the treated site demonstrates that the test item was not well tolerated by the skin of the rats after 24 hours of semi-occlusive exposure. The body weight changes observed during the study were within the expected range for this species and age of animals.

No abnormalities were found at necropsy carried out in the animals at termination of the study.

These results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, has no systemic toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:

Classification: No Category

Signal word : No Signal word required

Hazard statement: No hazard statement required

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Just one good study is available

Additional information

Just two good studies are available on the substance, but both agreed in not showing any clinical sign and any toxicity at doses of 2000 mg/Kg bw for oral and dermal routes


Justification for selection of acute toxicity – oral endpoint
There is only one study on the substance assessing oral toxicity, but it is a reliable GLP well described new study

Justification for selection of acute toxicity – dermal endpoint
There is only one study on the substance assessing oral toxicity, but it is a reliable GLP well described new study

Justification for classification or non-classification

Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg both for oral and dermal exposure pattern

No classification for acute toxicity oral is warranted under Regulation 1272/2008

No classification for acute toxicity dermal is warranted under Regulation 1272/2008