Reaction mass of 3-[(2-aminoethyl)ammonio]propane-1-sulfonate and 3,3'-(ethane-1,2-diyldiammonio)dipropane-1-sulfonate and ethane-1,2-diamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 2008 - Jan 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Actual guideline method. GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2-aminoethyl)amino]propane-1-sulfonic acid

Cas Number:

14235-54-2

Molecular formula:

C5H14N2O3S

IUPAC Name:

3-[(2-aminoethyl)amino]propane-1-sulfonic acid

Details on test material:

Hill formula: C5H14N2O3S.
Molecular mass: 182.24
Batch No.: 06060423/101.
Forms of the test substance supplied: Two forms of the test substance were supplied by the sponsor:
1) The highly viscous to solid test substance, containing ca. 5 % residual water. This form was produced by the sponsor by evaporating the water of the ca. 50 % solution of EPS in a rotating evaporator.
This form of the test substance was not used for the present test.
2) A ca. 50 % solution of EPS in water. Actually the concentration is 48.5 % w/w, according to the sponsor.
This form was used for the test.
Appearance of the solution of the test substance: Clear yellowish-brown liquid.
Solubility: Miscible with water.
Conditions of storage for both forms: Room temperature in the dark.
Stability at conditions of storage for both forms: Stable.
Stability of an aqueous solution: Stable.
Expiry date: Not available.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species, strain: Rats, Crl:CD(SD).
Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.
Number of animals and sex: 5 males and 5 females. Females were nulliparous and non-pregnant.
Age: Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
Hygienic status: Optimal hygienic conditions.
Room number: EH1-23.
Room temperature: Average of 22.2 °C (continuous control and recording).
Relative humidity: Average of 47.5 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
Bedding material: Aspen wood chips, Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved. Random samples of the bedding material are analysed for contaminants by the supplier. Changes 1 / week.
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week.
Feed: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff.
Water: Tap water, from an automatic watering system, ad libitum. Random samples of the water are analysed by the "AGES", A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
Identification: Labelling with felt-tipped pen on the tail and on the cage.
Acclimatisation: At least 5 days.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

A single dermal administration was performed by spreading the test substance on an area of at least 10 % of the estimated body surface.
The test site was located on the dorsal thoracal region. An area of 6.5 cm x 8 cm (52 cm2) was marked on a relaxed animal.
The hair of the dorsal trunk was clipped with an electrical hair clipper (Aesculap GH, 0.1 mm cutter head) one day before application of the test substance. The amounts of the test substance were calculated and weighed for each individual using the body weights determined on the day of the administration. A cellulose patch (Pehazell, Hartmann AG) with the calculated amount of the test substance on the surface was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M). Patch and tape were covered semi-occlusively by a dressing (Fixomull Stretch, Fa. Beiersdorf). At the end of the exposure period the dressing, the tape and the patch were removed. Residual test substance was wiped off using wet cellulose tissue, if necessary.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Observations in life:
Performed 0 - 0.5, > 0.5 - 1, > 1 - 2, > 2 - 4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Body weights determined:
before administration, 7 days p.a., 14 days p.a.
Body weight gain was calculated for each week of the study, i.e. between 0 and 7 days p.a. and 7 and 14 days p.a.

Necropsy:
All animals were sacrificed by inhalation of 80 % CO2 + 20 % O2 14 days p.a. and subjected to a necropsy including a gross pathological examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: General findings: All animals did not show any clinical signs during the entire observation period. Observations of skin condition: Exposed skin was not found to be altered by the test substance.

Gross pathology:

No abnormal findings were made in the animals at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No local or systemic test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight.

Executive summary:

In an acute dermal toxicity study 5 male and 5 female Crl:CD(SD) Rats were exposed to "3-[(2-aminoethyl)ammonio]propane-1-sulfonate" with a dose of 2000 mg/kg body weight. No local or systemic test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. No classification of "3 -[(2 -aminoethyl)ammonio]propane-1 -sulfonate " is therefore derived from the results of this study according to the Directive 2001/59/EC.