Registration Dossier

Diss Factsheets

Administrative data

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.

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: 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

Test material

Constituent 1
Chemical structure
Reference substance name:
di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid
EC Number:
939-714-0
Cas Number:
1474044-77-3
Molecular formula:
C18H30SO3 to C40H67SO3
IUPAC Name:
di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid
Test material form:
other: used as 50% solution in light naphthenic petroleum oil
Details on test material:
Synex 1052 (black-brown I iquid):
50% DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID)
50% Light Naphthalenic Petroleum Oil

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system 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.

Administration / exposure

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

Results and discussion

Preliminary study:
The study was a limit test without a preliminary exposure.
Effect levelsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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).