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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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

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.