Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From May 16,2012 to June 20,2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guidelines

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.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
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
- Substance type: organic viscous paste
- Analytical purity:no data
- Storage condition of test material: Room temperature
- Water content: 15%

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levelsopen allclose all
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.

Applicant's summary and conclusion

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 C14-17, chloro, sulfochlorinated, low sulphonated, saponified, 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 C14-17, chloro, sulfochlorinated, low sulphonated, saponified

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 C14-17, chloro, sulfochlorinated, low sulphonated, saponified, 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