Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

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.

Test guideline 2

Qualifier:

according to guideline

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. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified

EC Number:

939-273-4

Molecular formula:

CnHxCly(SO3Na)z • n= 14-17 • z < 0,5 • y = 0 ÷ 2,7

IUPAC Name:

Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 176 to 200 g
- Housing: limited access rodent facility, individually housed in polisulphone solid bottomed cages measuring 59 x 38.5 x 20 cm. Nesting material will 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: 22°C ± 2°C
- Humidity: 55% ± 15%
- Air changes: 15 to 20 air changes per hour
- Photoperiod: 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 place 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.

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 cavities 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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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:

other: remarks

Applicant's summary and conclusion

Interpretation of results:

other: not classified as toxic according to the CLP Regulation (EC) No. 1272/2008

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