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

Endpoint summary

Description of key information

The oral LD50 is > 2500 mg/kg.
The dermal LD50 is > 10,000 mg/kg.
The use as additive is unlikely to result in significant human exposure to inhalable droplets. In addition, a 1 hour exposure at 9 mg/L did not cause mortality.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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.

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An appropriate number of animals were exposed to a concentration (~18 mg/L) greatly exceeding the standard limit concentration (5 mg/L).

Qualifier:

according to guideline

Guideline:

other: FHSLA, CFR, Title 21 J para. 191.10.

Deviations:

not specified

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

A group of five male and five female Wistar rats were exposed to the test
material.

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

Rats were exposed to NASUL 729 (vaporized) in an inhalation chamber for 1 hour. The chamber was saturated with
18 mg/liter nominal of the test material prior to the period of exposure.
The rats were observed for 14 days following exposure. Feed and water were provided ad libitum.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 1 h

Concentrations:

18 mg/liter nominal

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Statistics:

None required. No mortality.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 18 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

1 h

Mortality:

No mortality.

Clinical signs:

other: No untoward reactions.

Body weight:

See table.

Gross pathology:

None reported.

Rat No.	Sex	Body Weight - grams	Mortality
1	M	229	No
2	M	265	No
3	M	229	No
4	M	256	No
5	M	263	No
6	F	291	No
7	F	271	No
8	F	256	No
9	F	261	No
10	F	278	No

Interpretation of results:

other: relatively harmless

Conclusions:

The Inhalation LC50 of rats exposed for 1 hour to the test material is greater than 18 mg/liter.

Executive summary:

A group of five male and five female Wistar rats were exposed to NASUL 729. The rats were exposed to NASUL 729 (vaporized) in an inhalation chamber for 1 hour. The chamber was saturated with 18 mg/liter nominal of the test material prior to the period of exposure. The rats were observed for 14 days following exposure. Feed and water were provided ad libitum. No mortalities or clinical symptoms observed. The Inhalation LC50 of rats exposed for 1 hour to the test material is greater than 18 mg/liter. On an active ingredient basis the LC50 > 9 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

9 000 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Methods generally follow accepted procedures for acute dermal toxicity studies. The applied dose exceeds current requirements and the result is considered valid.

Qualifier:

equivalent or similar to guideline

Guideline:

other: FHSLA, CFR. Title 21. para. 191.10 and Appraisal of the Safety of 'Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the U.S.

GLP compliance:

no

Test type:

other: limit test

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Five male and 5 female rabbits were prepared by cl ipping the skin of the trunk
free of hair. Epidermal abrasions were made over a 5-6 cm2 area on 2 males and 3
females. A patch containing 20 g/kg body weight of the test material was placed over a
5-6 cm2 area on all rabbits and secured with an elastic sleeve. The rabbits were immobil ized
in head stocks for 24 hours at which time the patches were removed and the rabbits returned
to their cages. Feed and water were provided ad libitum. The rabbits for observed for 14 days.

Duration of exposure:

24 hours

Doses:

20 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 other: g / kg bw

Mortality:

No mortality.

Clinical signs:

other: Anorexia - first 5 days, some weight loss, reversed after 9 days.

Rabbit-No.	Sex	BodyWeight kg	Dose grams	Mortality - Day -
1-abraded	M	3.0	60	Survived
2-abraded	M	3.0	60	Survived
3	M	2.92	59	Survived
4	M	2.88	57	Survived
5	M	2.92	58	Survived
6-abraded	F	2.33	47	Survived
7-abraded	F	2.46	49	Survived
8-abraded	F	2.60	52	Survived
9	F	2.75	55	Survived
10	F	2.68	54	Survived

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 > 20g/kg. The dermal LD50 on an active ingredient basis is > 10 g/kg (10,000 mg/kg).

Executive summary:

A dermal acute toxicity study was conducted with NASUL 729. This formulation contains 50% Calcium DNNSA.

Five male and 5 female rabbits were prepared by cl ipping the skin of the trunk free of hair. Epidermal abrasions were made over a 5-6 cm2 area on 2 males and 3 females. A patch containing 20 g/kg body weight of the test material was placed over a 5-6 cm2 area on all rabbits and secured with an elastic sleeve. The rabbits were immobil ized in head stocks for 24 hours at which time the patches were removed and the rabbits returned to their cages. Feed and water were provided ad libitum. The rabbits for observed for 14 days.

No mortalities occurred. Anorexia was reported for the first 5 days, some weight loss occurred but reversed after 9 days. NASUL 729 is practically non-toxic by dermal exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
An oral LD50 was conducted with NASUL 729, a 50% formulation of Calcium DNNSA. No clinical symptoms were reported. One male rat died on day 1. The oral LD50 is > 5000 mg/kg. On an active ingredient basis, the LD50 is > 2500 mg/kg.

Justification for selection of acute toxicity – inhalation endpoint
The use as additive is unlikely to result in significant human exposure to inhalable droplets.
Rats were exposed to NASUL 729 (vaporized) in an inhalation chamber for 1 hour. The chamber was saturated with
18 mg/liter nominal of the test material prior to the period of exposure. The rats were observed for 14 days following exposure.

Justification for selection of acute toxicity – dermal endpoint
A dermal acute toxicity study was conducted with NASUL 729 at a high dose of 20 grams/kg. This formulation contains 50% Calcium DNNSA.
Five male and 5 female rabbits were tested. Epidermal abrasions were made over a 5-6 cm2 area on 2 males and 3 females to increase dermal exposure.

Justification for classification or non-classification

Based on finding in acute oral, dermal and inhalative studies with the reference substance it can be concluded that no classification for acute toxicity by oral, dermal or inhalative route is required according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC). Given the high viscosity and the fact that Ca-DNNSA is not a pure hydrocarbon, classification for aspiration hazards is not required. No specific target organ toxicity was observed in any of the acute studies and thus STOT single exposure classification is not required.