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Administrative data

Description of key information

In acute oral testing, the LD50 was greater than 5000 mg/kg (2500 mg/kg based on purity). One of 10 animals died at a dose of 5000 mg/kg.
In acute dermal testing, the LD50 was greater than 2 milliliters/kg or 2000 mg/kg (1000 mg/kg based on purity). No adverse effects were observed.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study followed accepted practices for an acute oral toxicity limit test. An appropriate number of animals were used with a high dosing regime (5000 mg/kg) and 14 day observation period.
Qualifier:
according to
Guideline:
other: Acute Oral Toxicity. FHSLA, CFR Title 21, para. 191.1.
Deviations:
not specified
GLP compliance:
no
Test type:
other: Limit Test
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Single dose of 5000 mg/kg
No. of animals per sex per dose:
5 male
5 female
Control animals:
no
Details on study design:

5 male and 5 female rats weighing 200-239 grams were fasted for 18 hours and then individually and singly dosed by gavage. 
The animals were observed for mortality and other signs of gross toxicity for 14days.
Food and water were provided ad-libitum.
Statistics:
None necessary.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
act. ingr.
Mortality:
1 female died on day 8 post-dosing.
No males died.
Clinical signs:
No clinical symptoms of poisoning occurred
Body weight:
At initiation males weighed 209 - 239 grams and females 200 - 206 grams. Termination weights not reported.
Gross pathology:
Gastrointestinal bloat observed.

 

Group

Dose mg / kg bw

Male

Female

% Mortality

1

5000

0/5

1/5

10

 

Oral LD50 : >5,000 mg/kg  

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
DNNSA is practically non-toxic with an oral LD50 > 2500 mg/kg.
Executive summary:

An acute oral toxicity study (limit test) was conducted with Synex 1052, a 50% formulation of DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID). 5 male and 5 female rats weighing 200-239 grams were fasted for 18 hours and then individually and singly dosed by gavage. The animals were observed for mortality and other signs of gross toxicity for 14days. Food and water were provided ad-libitum. 1 female died on day 8 post-dosing.

No males died. No clinical symptoms of poisoning occurred. The Synex 1052 formulation is practically non-toxic with an oral LD50 > 5000 mg/kg. The DNNSA component is also practically non-toxic with an LD50 > 2,500 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study followed guidelines appropriate at the time of the study. 10 animals were tested at the very high concentration of 200 mg/L and no toxicity was evident.
Qualifier:
according to
Guideline:
other: Acute Inhalation Study. US FHSLA, CFR, Title.21, 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 and environmental conditions:
The spray was introduced into the chamber via a nebulizer, was circulated and was directed away from the animals. The chamber was saturated with 200mg/liter.
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Five male and five female Wistar rats, 200 - 300g. A group of five male and five female Wistar rats were exposed to an aerosol
of the test material in an inhalation chamber for one hour. The spray was introduced into the chamber via a nebulizer, was circulated and was directed away from the animals. The chamber was saturated with 200mg/liter, nominal, of test material prior to the period of exposure.
The rats were observed for 14 days following exposure.
exposu reo
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 1 h
Concentrations:
200 mg/L
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Statistics:
None Required
Preliminary study:
The study was a limit test without a preliminary exposure.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 200 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 100 mg/L air
Based on:
act. ingr.
Exp. duration:
1 h
Mortality:
No mortality
Clinical signs:
other: No clinical symptoms or other adverse effects
Body weight:
See table - attached
Gross pathology:
No remarkable findings.

Body Weights of Wistar Rats

Rat No.

Sex

Body Weight - grams

Mortality

1

M

230

No

2

M

241

No

3

M

256

No

4

M

267

No

5

M

280

No

6

F

214

No

7

F

217

No

8

F

225

No

9

F

232

No

10

F

230

No

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: EPA Category IV ( practically non-toxic based on LC50 greater than 20 mg/L)
Conclusions:
A one-hour exposure to a 50% formulation of DNNSA at 200 mg/L was not toxic to male and female Wistar rats.
Executive summary:

Synex 1052, a 50% liquid formulation of DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID), was evaluated for acute inhalation toxicity. Five male and five female Wistar rats, (Body Wt. 200 - 300g) received a whole body exposure for one hour to an aerosol of the test material in an inhalation chamber. The spray was introduced into the chamber via a nebulizer, was circulated and was directed away from the animals. The chamber was saturated with 200 mg/liter, nominal, of test material prior to the period of exposure. The rats were observed for 14 days following exposure. In the one-hour exposure, and during the 14 day observation period, the test material did not cause mortality or clinical symptoms of poisoning. The 1-hour LC50 is > 200 mg/L of the 50% formulation of DNNSA. Based on the concentration of DNNSA, the 1-hour LC50 is > than 100 mg/L. The study reports that the result support classification as EPA Category IV (practically non-toxic based on LC50 greater than 20 mg/L).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.

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: Study follows generally accepted practices. Result (>2 ml/kg) gives clear indication of low toxicity by dermal route.
Qualifier:
according to
Guideline:
other: This test methodology follows the procedure of the US Federal Hazardous Substances Act (1973) to determine substance toxicity.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
Ten healthy mature albino rabbits of New Zealand variety were selected from the stock colony for this study. They were housed in individual
stainless steel cages. Purina Rabbit Chow and water were available ad libitum.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The compound was applied to the moistened clipped skin of ten rabbits (five intact and
five abraded). The rabbits then were wrapped with a rubber dam. After 24 hours, the rubber dam was removed and the residue gently washed off.
Duration of exposure:
24 hour exposure
Doses:
2 ml / kg
No. of animals per sex per dose:
10 (5 abraded and 5 unabraded)
Control animals:
no
Details on study design:
The compound was applied at a dose of 2 ml per kg body weight to the moistened clipped skin of ten rabbits (five intact and
five abraded). The rabbits then were wrapped with a rubber dam. After 24 hours, the rubber dam was removed and the residue gently washed off.
The test site was examined for erythema and edema and scores were recorded daily for fourteen days. Body weights were recorded on Days 0 and 14. Rabbits were observed daily for signs of toxicity. All surviving animals were sacrificed at 14 days after treatment and a thorough necropsy was conducted.
Statistics:
Average body weights computed.
Preliminary study:
Dermal LD50 > 2 ml/kg
Dermal LD0 > 2 ml/kg
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
None.
Body weight:
All animals gained weight during the observation period. See table.
Gross pathology:
No abnormal effects observed.

Body Weights (g)

Animal Skin Day 0 Day 14
1 Abraded 2175 2230
2 Abraded 2370 2410
3 Abraded 2940 2990
4 Abraded 1915 2100
5 Abraded 2810 2885
6 Intact 2425 2510
7 Intact 2270 2340
8 Intact 2390 2465
9 Intact 2800 2895
10 Intact 2630 2720
     
Ave. 2472.5 2554.5
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: Guidelines established by the US Federal Hazardous Substances Act (1973)
Conclusions:
The dermal LD0 and LD50 are greater than 2 ml/kg.
Executive summary:

Ten healthy mature albino rabbits of New Zealand variety were selected from the stock colony for this study. They were housed in individual stainless steel cages. Purina Rabbit Chow and water were available ad libitum. The compound was applied at a dose of 2 ml/kg (liquid) to the moistened clipped skin of ten rabbits (five intact and five abraded). The rabbits then were wrapped with a rubber dam. After 24 hours, the rubber dam was removed and the residue gently washed off. The test site was examined for erythema and edema and scores were recorded daily for fourteen days. Body weights were recorded on Days 0 and 14. Rabbits were observed daily for signs of toxicity. All surviving animals were sacrificed at 14 days after treatment and a thorough necropsy was conducted.

The rabbits showed no signs of toxicity and no abnormal findings were noted in the necropsy. The dermal LD0 and LD50 are greater than 2 ml/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
1 000 mg/kg bw

Additional information

The available testing showed that DNNSA has low toxicity by oral and dermal routes. Based on the results of the acute oral test (LD50 > 2500 mg/kg) it is reasonable to assume that a dose of 2000 mg/kg in the dermal study would also have shown no mortality.


Justification for selection of acute toxicity – oral endpoint
Scientifically sound study following acceptable testing procedure.

Justification for selection of acute toxicity – inhalation endpoint
The use as a lubricant additive is unlikely to result in significant human exposure to inhalable droplets.
An inhalation study is available that was conducted with a 1 hour exposure (4 hour exposure is required). This study showed no toxicity at an exposure of 200 mg/Liter (Acute Inhalation Study, Report T-307, February 27, 1978 with Synex 1052 (50% DNNSA).

Justification for selection of acute toxicity – dermal endpoint
Scientifically sound study following acceptable testing procedure.

Justification for classification or non-classification

Based on finding in acute oral, dermal and inhalative studies with the 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 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.