Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., calcium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February - April 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Methods generally follow accepted procedures for acute oral toxicity studies. The number of animals tested (10) exceed current requirements and the result is considered statistically valid.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSLA, CFR Title 21, para. 191.1

Deviations:

not specified

GLP compliance:

no

Test type:

other:

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

50% Calcium DNNSA (CAS 57855-77-3)

IUPAC Name:

50% Calcium DNNSA (CAS 57855-77-3)

Details on test material:

A dark brown viscous liquid identified as NASUL 729

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were fasted for 18 hours and then individually and singly dosed by gavage
with 5 ml /kg body weight of test material. The rats were individually caged and observed
for mortal ity or other signs of gross toxicity for 14 days. Food and water were provided ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Limit dose of 5000 ml/kg body weight

No. of animals per sex per dose:

5 males and 5 females.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

One male rat died on day 1.

Clinical signs:

other: All animals appeared active and healthy.

Gross pathology:

No remarkable findings for animal 63 that died on day 1.

Any other information on results incl. tables

Rat-No.	Sex	BodyWeight-Initial grams	Dose ml	Death Day
63	M	210	1.05	1
64	M	200	1.0	Survived
65	M	225	1.12	Survived
66	M	205	1.02	Survived
67	M	200	1.0	Survived
47	F	228	1.14	Survived
48	F	210	1.05	Survived
49	F	213	1.06	Survived
50	F	219	1.10	Survived
51	F	200	1.0	Survived

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The rats were fasted for 18 hours and then individually and singly dosed by gavage
with 5 ml /kg body weight of test material. The rats were individually caged and observed
for mortal ity or other signs of gross toxicity for 14 days. Food and water were provided ad libitum.
The test material is not toxic at a single oral dose of 5ml/kg. The oral LD50 is > 5g/kg. On an active ingredient basis, the LD50 is > 2.5 mg/kg.

Executive summary:

An oral LD50 was conducted with NASUL 729, 50% Calcium DNNSA (CAS 57855-77-3). Five male and five female Sprague Dawley derived albino rats were fasted for 18 hours and then individually and singly dosed by gavage with 5 ml /kg body weight of test material. No clinical symptoms were reported. One male rat died on day 1. The test material was considered not toxic at a single oral dose of 5ml/kg. The oral LD50 is > 5g/kg. On an active ingredient basis, the LD50 is > 2.5 mg/kg.