Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 (Acute Oral Toxicity)

Deviations:

not specified

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner/Ottobrunn, Germany
- Weight at study initiation: mean: male = 225 g, female = 165 g
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous solution with traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4, 8, 16, 20, 30%

Doses:

3200, 2500, 2000, 1600, 800, 400 mg/kg bw

No. of animals per sex per dose:

10; except for the 1600 mg/kg bw dose group (20 animals per sex)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes

Statistics:

no data available

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

ca. 1 800 mg/kg bw

Based on:

test mat.

Remarks:

(equivalent to the substance as registered)

Mortality:

3200 mg/kg bw: all animals died within 24 hours
2500 mg/kg bw: 9/10 males and all females died within 24 hours
2000 mg/kg bw: 5/10 males died (4 within 48 hours, 1 between 7 and 14 days); 7/10 females died within 24 hours, one more after 48 h and by day 14 all females were dead
1600 mg/kg bw: 0/20 males died; 11/20 females were dead after 24 hours, 12/20 after 48 hours and 13/20 after 7 days
800 and 400 mg/kg bw: all animals survived

Clinical signs:

other: 3200 mg/kg bw: dyspnea, partly diarrhea remaining dose groups: dyspnea, dislike to move, calm behavior after administration of high doses (2500 and 1600 mg/kg bw, respectively) partly abdominal position, bloody snout and paw; surviving animals after 6 to

Gross pathology:

found dead: smeared anus (result of diarrhea), ectasia of stomach which contained a lot liquid, loose intestinal tract, slightly serous blurred snouts
sacrificed scheduled: nothing abnormal detected

Other findings:

no data available

Any other information on results incl. tables

Table: results

Doses mg/kg	Concentration in vehicle %	N° of animals	mortality
			1 hour	24 hours	48 hours	7 days	14 days
3200	30	10 males 10 females	0/10 0/10	10/10 10/10	10/10 10/10	10/10 10/10	10/10 10/10
2500	20	10 males 10 females	0/10 0/10	9/10 10/10	9/10 10/10	9/10 10/10	9/10 10/10
2000	20	10 males 10 females	0/10 0/10	0/10 7/10	4/10 9/10	4/10 10/10	5/10 10/10
1600	16	20 males 20 females	0/20 0/20	0/20 11/20	0/20 12/20	0/20 13/20	0/20 13/20
800	8	10 males 10 females	0/10 0/10	0/10 0/10	0/10 0/10	0/10 0/10	0/10 0/10
400	4	10 males 10 females	0/10 0/10	0/10 0/10	0/10 0/10	0/10 0/10	0/10 0/10

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the oral LD50 of Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda was ca. 1800 mg/kg in rats.

Executive summary:

In an acute oral toxicity study (similar to OECD TG 401; 1970), groups of Sprague Dawley rats (10 or 20/sex) were given a single oral dose of the test substance in an aqueous solution with traganth at 3200, 2500, 2000, 1600, 800 and 400 mg/kg bw and observed for 14 days. Mortality occurred from the 1600 mg/kg bw dose group onwards. Dyspnea and diarrhea were seen, being common symptoms in acute tests. Surviving animals recovered after 6 to 13 days. At autopsy, liquid filled stomachs and loose intestinal tracts were found. No deviations from normal morphology were found in the animals which were scheduled sacrificed. An approximated LD50 of ca. 1800 mg/kg bw was estimated.

As the acute oral LD50 was ca. 1800 mg/kg under the conditions of the test, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is classified as Acute tox. 4 (H302) according to the Regulation (EC) 1272/2008 (CLP) and as harmful Xn, R22 according the Directive 67/548/CEE.