Dinonylnaphthalenedisulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP study with limited information on test design and results. The study allows a conclusion on the height of the LD50. The information in the report is limited to the information in the summary.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

method seems similar to OECD 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dinonylnaphthalenedisulphonic acid

EC Number:

262-110-7

EC Name:

Dinonylnaphthalenedisulphonic acid

Cas Number:

60223-95-2

Molecular formula:

C28 H44 O6 S2

IUPAC Name:

dinonylnaphthalenedisulphonic acid

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Nacure 155

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data:
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:

2000, 3000, 4000, 4500 and 5000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

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: no, only on decendents
- Other examinations performed: clinical signs

Statistics:

Litchfield-Wilcoxin Probit Analysis

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 700 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 080 - <= 4 440

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 035 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 1 694 - <= 2 442

Mortality:

1 male + 1 female at 2000 mg/kg bw
2 males + 1 female at 3000 mg/kg bw
2 males + 3 females at 4000 mg/kg bw
1 male + 5 females at 4500 mg/kg bw
4 males + 4 females at 5000 mg/kg bw

Clinical signs:

none

Body weight:

no data

Gross pathology:

degeneration and necrosis of the stomach; liver discoloration in several dead rats

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

tance is 2035 mg/kg bw

Executive summary:

Groups of rats (5/sex/dose) received a single dose of the test substance at 2000, 3000, 4000, 4500 and 5000 mg/kg bw. In all groups mortality was reported. Necropsy showed degeneration and necrosis of the stomach as well as liver discoloration in several dead rats. The LD50 is 2035 mg/kg bw.