Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 28 - Feb 17, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(24 Feb 1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts

EC Number:

701-179-4

Molecular formula:

(C18H33)nO7K2S, n= 1-2

IUPAC Name:

Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts

Specific details on test material used for the study:

- Name of test material (as cited in study report): Octadecanoic acid, sulfo-, potassium salt
- Test item No.: 14/0449-1
- Physical state/appearance: liquid, brownish
- Analytical purity: 51.92%
- Homogeneity: homogeneous by visual inspection
- Stability: stable under storage conditions
- Expiry date: June 22, 2016
- Storage conditions: room temperature
- Lot/batch No.: 0012127444
- Density: 1.111 g/mL

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Additional strain characteristics: Crl:WI (Han)
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks (males), 12 weeks (females)
- Mean weight at study initiation: approx. 240.6 g (males), 211.8 g (females)
- Housing: single housing in Makrilon cages type III
- Diet: VRF 1 (P) (SDS Special Diets Services, Altrip, Germany), ad libitum (analyses for chemical and microbial contaminants by the manufacturer was performed in quarterly intervals)
- Water: tap water, ad libitum (analyses was regularly performed by the municipal authorities of Heidelberg)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 40 cm² (dorsal and dorso-lateral parts of the trunk)
- % coverage: at least 10%
Fur was removed by clipping about 24 h before administration.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.29 mL/kg bw
- Concentration: 100%
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: shortly before administration, weekly thereafter and on the last day of observation
- Frequency of observations: several times on the day of administration and at least once daily thereafter each workday
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, scoring of skin findings Skin findings (according to Draize)

Statistics:

Calculations were perfomred using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs of toxicity were observed during clinical examination. Local skin effects at the application site comprised in one male animal well-defined erythema (grade 2) on study day 1, which decreased to very slight erythema (grade 1) fro

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information