Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: applied as 50% solution in light paraffinic petroleum oil
Details on test material:
Synex 1052 is a brown-black viscous liquid.
Composition:
50% DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID)
50% light paraffinic petroleum oil

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

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.

Results and discussion

Effect levelsopen allclose all
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.

Any other information on results incl. tables

 

Group

Dose mg / kg bw

Male

Female

% Mortality

1

5000

0/5

1/5

10

 

Oral LD50 : >5,000 mg/kg  

Applicant's summary and conclusion

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.