Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a method equivalent to EU / OECD guidelines and was performed before GLP implementation.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium isopropylnaphtalene sulfonate

IUPAC Name:

sodium isopropylnaphtalene sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

See confidential details on test material section

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source, Age at study initiation, Weight at study initiation, Housing, Diet, Water, Acclimation period: data not available

ENVIRONMENTAL CONDITIONS:
- Temperature, Humidity, Air changes, Photoperiod: data not available

IN-LIFE DATES: data not available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no data available
- % coverage: no data available
- Type of wrap if used: a cuff of polyethylene film which encircled the trunk of the animal


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable


TEST MATERIAL
- Amount(s) applied: 2500, 5000 and 10000 mg/kg
- Concentration (if solution): 2500, 5000 and 10000 mg/kg
- Constant volume or concentration used: not applicable
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied: not applicable
- Concentration: not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of exposure:

24 hours

Doses:

2500, 5000 and 10000 mg/kg

No. of animals per sex per dose:

4 animals at 2500 and 5000 mg/kg ; 5 animals at 10000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: yes
- Other examinations performed: local irritation

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

ca. 4 200 mg/kg bw

Based on:

test mat.

Mortality:

5 animals died at 10000 mg/kg within the period of exposure. 3/5 animals died at 5000 mg/kg.

Clinical signs:

other: Severe erythema and edema of the skin of the affected area, with capillary hemorrhages and congestion of the larger vessels in the dermis were obserbed at 10000 mg/kg. Skin irritation at the lowest dosage was initially equally severe as that seen at the h

Gross pathology:

The only noteworthy gross pathology, excluding the skin, that was seen at autopsy was somewhat pronounced congestion of the blood vessels of the stomach and small intestine.

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the dermal LD50 of the test item sodium isopropylnaphtalene sulfonate was calculated as 4200 mg/kg in rabbits.

Executive summary:

The substance sodium isopropylnaphtalene sulfonate has been tested for acute dermal toxicity in Male Albino rabbits, according to similar O.E.C.D. guideline Nb.402. The test article (75% active) was applied as an aqueous paste to groups of male albino rabbits at doses of 2500, 5000 and 10000 mg/kg bw, respectively under an occlusive dressing applied for 24 hours. At the end of the period of exposure, the cuff and any excess of the dose were removed, and the skin examined for primary irritation for 7 days.

At 10000 mg/kg, 5 animals died within the period of exposure. At 5000 mg/kg, 3/5 animals died. Severe erythema and edema of the skin of the affected area, with capillary hemorrhages and congestion of the larger vessels in the dermis were obserbed at 10000 mg/kg. Skin irritation at the lowest dosage was initially equally severe as that seen at the higher dosages. Over the course of the observation period, edema subsided within 2 to 3 days, but the formerly erythematous areas became blackened and leathery. This appearance persisted until sacrifice at 7 days after the dose.

The only noteworthy gross pathology, excluding the skin, that was seen at autopsy was somewhat pronounced congestion of the blood vessels of the stomach and small intestine.

As the acute dermal LD50 was calculated as 4200 mg/kg under the conditions of the test (i.e 3150 mg/kg in terms of active ingredient), sodium isopropylnaphtalene sulfonate is not classified according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/CEE.