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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 13 days without abnormal symptoms.
Body weight:
no data available
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.