Reaction product of naphthalene, butanol, 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 is sufficiently documented. Basic data given: comparable to guidelines/standards. Test substance purity is 65%.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium diisobutylnaphtalene sulfonate

Cas Number:

91078-64-7

IUPAC Name:

sodium diisobutylnaphtalene sulfonate

Test material form:

not specified

Details on test material:

See confidential details on test material section

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BASF
- Weight at study initiation: mean: male and female = 2.4 kg
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

The product was administered in various dosages as a 50% aqueous dispersion processes once to the shaved skin.

Duration of exposure:

24 hours

Doses:

1000, 2000, 4000 mg/kg bw

No. of animals per sex per dose:

4000 mg/kg: 4 males and 2 females; 2000 mg/kg: 1 male and 2 females; 1000 mg/kg: 2 males and 1 female

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes

Statistics:

no data available

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 000 mg/kg bw

Based on:

test mat.

Remarks:

(equivalent to the substance as registered)

Mortality:

4000 mg/kg: 3 males and 1 female died between 48 hours and day 14.
2000 and 1000 mg/kg: all animals survived

Clinical signs:

other: 4000 mg/kg: Apathy, weight loss, reduced food intake were observed. No clinical signs in the surviving animals after 3-4 days. 2000 and 1000 mg/kg: No clinical signs observed.

Gross pathology:

Deceased animal: Petechiae on the mucous membranes of the stomach in 3/4 rabbits at 4000 mg/kg.

Other findings:

no data available

Any other information on results incl. tables

Table: results

Doses mg/kg	Concentration %	N° of animals	mortality
			1 hour	24 hours	48 hours	7 days	14 days
4000	50	4 males 2 females	0/4 0/2	0/4 0/2	2/4 1/2	3/4 1/2	3/4 1/2
2000	50	1 male 2 females	0/1 0/2	0/1 0/2	0/1 0/2	0/1 0/2	0/1 0/2
1000	50	2 males 1 female	0/2 0/1	0/2 0/1	0/2 0/1	0/2 0/1	0/2 0/1

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 Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda was ca. 3000 mg/kg in rabbits.

Executive summary:

The substance has been tested for acute dermal toxicity in rabbits, according to a method similar to O.E.C.D. guideline Nb.402. The test article was applied as a 50% aqueous dispersion to groups of male and female rabbits at doses of 1000, 2000 and 4000 mg/kg bw, respectively for 24 hours. At the end of the period of exposure, the animals were examined for 14 days.

At 4000 mg/kg, 3 males and 1 female died between 48 hours and day 14. Apathy, weight loss, reduced food intake were observed. No clinical signs were observed in the surviving animals after 3-4 days. At 2000 and 1000 mg/kg, all animals survived. No clinical signs were observed.

As the acute dermal LD50 was calculated as ca. 3000 mg/kg under the conditions of the test, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is not classified according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/CEE.