Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 May 1990 - 23 May1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate

EC Number:

915-932-1

Molecular formula:

Reaction mass of C12H8O8S3.2K and C12H9O5S2.K

IUPAC Name:

Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test substance: Additive VP KU 1-1909
Lot#: DZA-UER -8919598-A
Manufacturer: Bayer AG, Leverkusen
Purity: 86.5% (see annex, appendix.3)
Identity/Stability: guaranteed for the study period
Storage: room temp, darkness
CAS #: 63316-43-8
Molecular weight: 336 g/mol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were housed in cages on low dust wood granules, at a room temperature of 22 +/- 2 degrees celsius, with artificial lighting from 6am to 6 pm, relitive humidity of about 50 +/- 10% and aprox ten air changes per hour. All animals used for this experiment were house in a single room. At the samw time animals from other acute studies were kept in the same animal room. Due to sufficient spatial separation the adequate organization of the sequence of operations a mixing up of animals of influence by another was excluded.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The substance was dissolved in tap water on a magnetic stirrer at approx. 60 degrees celsius and then applied to the prepared skin area at a volume corresponding to dose and animal weight. it was covered with gauze and aluminum foil and fixed with non-irritant skin plaster. The dressing was removed after approx 24 hours and possible substance residues on the skin were removed with luke-warm water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg-bw

No. of animals per sex per dose:

5 males and 5 females, each given 2000 mg/kg-bw.

Control animals:

no

Details on study design:

The animals were inspected several times on the day of administration and twice daily during the following 14-day observation period for clinical signs. Animals were individually weighed directly before administration and then once a week until the end of the observation period. Gross pathological examinations were done on all animals.

Statistics:

None. No animals died during the exposure or 14 day observation period.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0%. No animals died during the exposure or 14 day observation period.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No noticeable gross pathological findings

Any other information on results incl. tables

No clinical signs, changes in body weight, mortality, or gross pathological findings were noted in any of the 10 animals dermally exposed for 24 hours (occulsive dressing) at 2000 mg/kg-bw during this study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was determined to be non-toxic by the dermal route up to a concentration of 2000 mg/kg-bw.

Executive summary:

In a GLP guideline study conducted according to OECD 402 with 5 male and 5 female young Wister rats exposed to the test substance at 2000 mg/kg-bw for 24 hours under an occlusive dressing to assess the potential dermal toxicity, no clinical signs, changes in body weight, mortality, or gross pathological findings were noted in any of the animals during the exposure period or 14 day observation period. As such, the substance does not meet the criteria for acute toxicity by the dermal route.