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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
2,2’-Azobis(2-amidinopropane) dihydrochloride is expected not to be acute dermal toxic because the analogue 2,2’-Azobis(2-amidinopropane) sulfate has not shown acute dermal toxicity properties in a well performed study. The source chemical 2,2’-Azobis(2-amidinopropane) sulfate is sufficiently similar to read-across towards 2,2’-Azobis(2-amidinopropane) dihydrochloride.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 2,2'-Azobis (2-amidinopropane) sulfate
- Molecular formula (if other than submission substance): C8H20N6O4S
- Molecular weight (if other than submission substance): 296,347 g/mol
- Smiles notation (if other than submission substance): OS(O)(=O)=O.CC(C)(\N=N\C(C)(C)C(N)=N)C(N)=N
- InChl (if other than submission substance): InChI=1S/C8H18N6.H2O4S/c1-7(2,5(9)10)13-14-8(3,4)6(11)12;1-5(2,3)4/h1-4H3,(H3,9,10)(H3,11,12);(H2,1,2,3,4)
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: solid

Purity/impurities

The impurities in the target substance do not indicate toxicological relevence to this endpoint. The impurities are all below 1 %.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 207 to 300 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: aquesous methylcellulose 1%
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 %
- Type of wrap if used: aluminium foil, held in place with impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- suspended in vehicle
- Amount(s) applied (volume or weight with unit): 6.3 ml/kg bw
- Concentration (if solution): 60 % w/v suspension
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 6.3 ml/kg bw
- Concentration (if solution): 60 % w/v suspension
Duration of exposure:
24 hours
Doses:
3.78 g /kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No statistics necessary

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 780 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Local dermal reactions at the site of application included slight to well-defined erythemaof a focal nature in nine animals between one and four days after treatment. This was accompanied by slight oedema in six animals between one and four days after treatment. A small necrotic area (dimension 0.2 cm2) was recorded in two female rats. Amelioration of these reactions was apparently complete within twelve days of treatment in all rats.
Body weight:
Bodyweight gains for all treated males and for two treated female rats were depressed during the first week of observation only. Reduced bodyweight gains were also recorded in one treated and one control female rat throughout the 14-day observation period. Bodyweight losses were noted in one treated and one control female during the first week of observation
Gross pathology:
Terminal autopsy findings were normal

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:

For 2,2’-Azobis(2-amidinopropane) sulfate an in vivo study is available showing no dermal toxicity up to the dose of 3780 mg/kg bw.
Executive summary:

For 2,2’-Azobis(2-amidinopropane) sulfate an in vivo study is available showing no dermal toxicity up to the dose of 3780 mg/kg bw.