Sulfonic acids, C6-8-alkane, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 - 17 October 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkane C6-C8 (even numbered), 1-sulphonic acid, sodium salt

Cas Number:

1474044-66-0

Molecular formula:

CnH(2n+1)O3Na where n=6 or 8

IUPAC Name:

Alkane C6-C8 (even numbered), 1-sulphonic acid, sodium salt

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Bio-Terge PAS 7S-DRY
- Physical state: solid
- Analytical purity: >98%
- Lot/batch No.: PG12122011 (dried from industrial lot 7476775)
- Expiration date of the lot/batch: 12 December 2013
- Stability under test conditions: stable
- Storage condition of test material: Controlled room temperature (15-25 °C, < 70 % RH)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: Young adult
- Weight at study initiation: 201-251 g
- Fasting period before study: none
- Housing: individually caged in Type II polypropylene/polycarbonate cages
- Diet: ad libitum - ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 15-20/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back of each animal
- % coverage: approx 10 %
- Type of wrap if used: Sterile gauze pad kept in place with an adhesive hypoallergenic plater and wrapped with a semi-occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: Water at body temperature
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes (sample moistened with sufficient water to ensure good skin contact)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations on the day of treatment at 1 & 5 hours after application and once per day for 14 days thereafter. Bodyweights recorded on Day 0 (before test item administration) and on Days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

Administration of the test item at a dose level of 2000 mg/kg body weight did not cause any mortality.

Clinical signs:

other: No clinical signs were observed after treatment with the test item or during the 14-day observation period.

Gross pathology:

There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. The unilateral pelvic dilatation of the kidneys, observed in two male animals is considered to be an incidental macroscopic finding.

Other findings:

There were no observed local dermal signs after treatment with the test item at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity of the susbtance is > 2000 mg/kg bw.