Reaction mass of disodium sulphide and sodium carbonate and sodium hydroxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 08-08-2013 to 10-09-2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

no data

EC Number:

908-531-8

Molecular formula:

No data

IUPAC Name:

no data

Test material form:

other: Liquid

Details on test material:

The test item was applied undiluted.

Test animals

Species:

rat

Strain:

other: Wistar Hannover

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were housed individually, during acclimatization and observation periods, in polypropylene cages (30x18x19 cm) with wire mesh tops and bedding material (autoclaved wood shavings). the bedding was regularly assayed for sontaminants at the analytical laboratories of BIOAGRI Laboratorios/ Brazil, and was considered to be suitable on the basis of analytical analysis. The results are available for inspection. Clean cages were provided three times per week.
During the observation period of the animals, the room was maintained in temperature beetween 19.0 °C to 22.0 °C, with relative humidity of 34.2% to 54.9%, room ventilation set at 10 to 20 air changes oer hour, and a photoperiod of 12 hours light and 12 hours dark. Environmental control equipments were monitored and adjusted as necessary to minimize fluctuations in the animal room environment.
The food was autoclaved Nuvilab CR-1 pelleted diet type for rodents supplied by Nuvital Nutrientes Ltda. (Curitiba - PR, Brazil), which was available ad libitum throughout the study. Filtered drinking water was supplied by CAESB in water bottles for animals also ad libitum throughout the study. The food and water were regularly assayed for chemical and microbiological contaminants at the analytical laboratories. The food was assayed at BIOAGRI Laboratorio/Brazil for nutritional composition. Both, food and water, were found to be suitable on the basis of the analytical analysis and the results are available for inspection.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hour

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Five males and five females

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No anaimal died during the study.

Clinical signs:

other: All males showed excoriation with ulcer from day 1 until the end of the observation period. All males showed crust from day 9 until the end of the observation period, this was of different sizes according to the grade of injury, for example, the animal 1

Gross pathology:

Skin microscopic examination of the animals was performed. The microscopic findings compound-related observations were: moderate irritant contact dermatitis and severe corrosve contact dermatitis.
In this study, two types of contact dermatitis were found:
- Moderate irritant contact dermatitis: it was considered when lesion affected the dermis and epidermis without reaching the muscle
- Severe corrosive contact dermatitis: it was considered when the lesion affected deep structures of the skin. The severe grade reaches up the muscle.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of the test item for male and female rats was estimated as being greater than 2000 mg/kg body weight.