Naphthalenesulfonic acid, butyl-, Me derivs., sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-11-15 till 1978-12-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Performed before GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Limited reporting.
- 1 sex.
- Acclimation period and housing conditions are unknown.

GLP compliance:

not specified

Remarks:

Before GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Morwet B

IUPAC Name:

Morwet B

Test material form:

solid: granular

Details on test material:

Material: Petrochemicals Company, Inc. - Morwet B

Specific details on test material used for the study:

Commercial product.

Test animals

Species:

rat

Strain:

other: Sherman - Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Albino rats of the Sherman-Wistar strain
- Weight at study initiation: weighing between 200 and 300 gm
- Fasting period before study: 24 hours prior to dosing
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: a 20% w/v suspension in water (200 mg/ml)

MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg

Doses:

Dosage levels:
0,2 gm/kg
0,4 gm/kg
0,8 gm/kg
1,6 gm/kg
3,2 gm/kg

No. of animals per sex per dose:

5 male rats per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Weighing: Prior to dosing and final weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Remarks:

Based on interpolation to 50% mortality between 800 mg/kg bw (0% mortality) and 1600 mg/kg bw (60% mortality)

Effect level:

ca. 1 500 mg/kg bw

Based on:

test mat.

Mortality:

Dose level 1.6 gm/kg 3 animals died.
Dose level 3.2 gm/kg 5 animals died.

Clinical signs:

other: Dose level 0.2 gm/kg and 0.4 gm/kg animals were slightly lethargic (normal after 24 hours). Dose level 0.8 gm/kg animals were depressed (normal after 24 hours). Dose level 1.6 gm/kg animals were depressed and exhibited shallow respiration after 1 hour. Th

Gross pathology:

Gross pathologic examination revealed nothing remarkble in the surviving animals sacrified at the conclusion of the study.
Some Hemorrhaging of the upper G.I. tract was evident in the animlas that died.

Any other information on results incl. tables

Concentration: 200 mg/ml
Dosage Level gm/kg	Number of Animals Dosed	Mortalities Days														Total Dead 14 Days	Total Survived 14 Days	Initial Weight gm	Final Weight gm
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
0.2	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	240	280
0.4	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	215	250
0.8	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	260	280
1.6	5	2	1	0	0	0	0	0	0	0	0	0	0	0	0	3	2	240	255
3.2	5	5	-	-	-	-	-	-	-	-	-	-	-	-	-	5	0	235	-

Based on the results LD50 is around 1.5 gm/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The subject material when studied in male albino rats has an acute oral LD50 of around 1500 mg/kg bw.

Executive summary:

There was limited reporting.

The study was performed with similarities to OECD Guideline 401 (Acute Oral Toxicity), but not according to GLP standards.

The test material, Morwet B, was evaluated for its acute oral toxicity potential in albino rats when administered as gavage doses at levels of 0.2, 0.4, 0.8, 1.6 and 3.2 gm/kg to males. No mortality occurred in animals dosed at the 0.2, 0.4 and 0.8 gm/kg level. At 1.6 g/kg bw 3/5 animals died between 8 and 30 hours, and at 3.2 g/kg bw all 5 animals died in less than 2 hours.

Clinical signs of toxicity included shallow respiration and depression. Gross pathologic examination revealed nothing remarkable in the surviving animals sacrificed at the conclusion of the 14 -day observation period. Some haemorrhaging of the upper G.I. tract was evident in the animals that died.

Conclusions: The LD50 is about 1500 mg/kg bw.